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- Server/Network/rPDU device rack, stack and cable incl. Cable Management - Rack/MOR Cabling - General supervised Deployment support - Decommission IT equipment (server and network under MSFT supervision), DBD removal only (does not perform any scanning) - Physical audits of datacenter assets - Basic Server (Discrete/Rack-based) repair following documented procedures - Physically assist in moving and racking equipment - Maintain data center facilities removing debris and empty boxes once no longer needed - Hard drive shredding - Moving Locked DBD Bins to shred area - Audit and inventory management support &amp; spine clean up - Physical audit of drinks/stationary on campus and reorder as necessary through CBRE/Staples - Perform rack movementAdditional Skills &amp; QualificationsMust be willing to get their hands dirty when the time calls for it, working a pallet jack, running cables in the data center, inventory of devices/equipment. This isn't a strictly technical role.

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Data Center Technician

Responsibilities: • Will be handling about 35-45 inbound calls per day, sometimes more and sometimes less, depending on how long each call lasts, average is about 11-14 minutes per call. • This person will be responsible for handling inbound calls pertaining to insurance servicing questions. • Will receive questions from borrowers, insurance agents and financial institutions. • The insurance questions will pertain to home owners insurance and will be from borrowers, insurance agents and financial institutions. • Majority of calls will be in regards to payment and/or coverage questions. • The CSR must be able to multi-task between various systems to research and document the phone calls. • The CSR has to respond quickly and accurately ensuring that both our internal and external standards are being met on a consistent basis. • Problem solving and problem resolutions skills are required as well as the ability to handle all calls in a professional manner. MUST HAVE: • At least 1 year of RECENT customer service experience (call center experience is preferred, but will consider candidates with front desk/admin experience - NOT just retail or food service) • Efficient in using a windows PC computer and navigating their software system (super easy to learn) • typing: at least 35 WPM • Good verbal and written communication skills (will be on the phone all day and be required to follow up via email in some instances) • internet connection - will be required to train remote and work remote. • Reliable transportation NICE TO HAVE: • 2+ years of call center experience • Insurance or mortgage background

Customer Service Representative

Job DescriptionPosition Overview: As a Member Services Representative, you will be the first point of contact for members seeking assistance with their health plan benefits, account status, and service-related inquiries. This is a high-impact role requiring empathy, attention to detail, and a commitment to delivering exceptional service. Key Responsibilities: -Respond to inbound calls and digital inquiries from Medicare and Medicaid members regarding benefits, claims, payments, and services. -Resolve member concerns with professionalism and empathy, ensuring first-contact resolution whenever possible. -Document all interactions accurately in the system according to compliance and procedural standards. -Collaborate with internal departments and external partners (e.g., medical groups, facilities) to resolve complex issues. -Meet or exceed performance metrics including call handling time, resolution rate, and customer satisfaction. -Participate in ongoing training and coaching sessions to maintain up-to-date knowledge of products and procedures.Additional Skills &amp; Qualificationso Must have a High School Diploma or GED o Must be flexible to work varied shifts ranging anywhere from 8 a.m. to 8 p.m., seven days a week. o Possess excellent listening skills/ability to analyze for resolution and be solution-oriented. o Must possess above-average verbal and written communication skills, proven soft skill abilities/proficiency, a strong attention to detail, and an interest in preventing errors. o Demonstrate critical thinking and decision-making abilities. o Must possess demonstrated competency in Windows (*Outlook, Word, Internet Explorer, Excel, and PowerPoint). o Ability to deliver ‘delightful’ customer service experiences and build customer satisfaction and loyalty. o Strike a positive and cooperative tone with both customers and coworkers. o Possess a positive attitude, is upbeat, outgoing, and confident. o Be self-reliant and dependable, ability to work independently and as a team. o Be patient, stress-tolerant, and show empathy. o Ability to thrive in a lively working environment and multi-task. o Ability to accept constructive feedback. o Possess ability and/or some experience in presentation capability to individuals, groups, and leadership audiences. o Ability to mentor peer group in best practice standards o Must be a team player, self-starter, and have demonstrated initiative. o Must be able to build and/or retain excellent customer relationships. o Must possess the ability to problem solve and resolve customer complaints. o Must possess the ability to upsell our products and our company, possess a sales aptitude, be passionate about our products and our customers. o Must possess basic reading, writing, and arithmetic skills (reading/math comprehension). o Must be able to do some travel. o Service-oriented, actively looking for ways to help people. o Meet quality, productivity, and behavior expectations.

Member Services Representative

Summary Location: this role will be based in Cambridge, MA US. LI-#hybrid The Novartis Strategy & Growth, Corporate and Business Development team is seeking a new Associate Director, Search and Evaluation (S&E). This individual will report to the Head of Search & Evaluation for Platforms and AI and will play a key role in identifying and evaluating external platform technologies that align with strategic priorities across the value chain, from discovery to commercialization. About the Role Key responsibilities: <ul><li>Build and analyze competitive landscapes and innovation ecosystems in strategic areas of interest to inform search priorities and opportunity assessments.</li><li>Collaborate with internal stakeholders across R&D, commercial, and corporate development functions to drive strategic growth through partnerships, licensing, and M&A.</li><li>Present opportunities within the global S&E team and broader C&BD team.</li><li>Represent Novartis externally at industry conferences, and meetings to build relationships and enhance visibility.</li><li>Build and maintain a robust knowledge base of emerging platform technologies and trends.</li><li>Deliver against the S&E organization's Business Development & Licensing strategies and plans/objectives.</li><li>Lead the execution of search activities and ensure alignment with strategic priority targets.</li><li>Conduct triage and due diligence on inbound opportunities, ensuring thorough documentation and internal alignment.</li><li>Collaborate with internal teams to prepare materials for governance and deal execution.</li><li>Work constructively with key stakeholders, present to internal leadership teams, and drive internal consensus on opportunities.</li><li>Support the formal governance process and adhere to internal BD&L review standards to ensure consistency and quality in evaluations.</li><li>Actively participate in external engagements to support branding and visibility of the S&E team.</li></ul>Essential requirements: <ul><li> Bachelor's degree in life sciences required. Advanced degree (PhD, MD) is strongly preferred. </li><li> 5+ years of experience in business development, strategy, consulting or R&D within the pharmaceutical or biotech industry. </li><li> Demonstrated understanding of drug discovery, clinical development, and platform technologies. </li><li> Strong analytical, organizational, and communication skills. </li><li> Ability to work independently and collaboratively in a matrixed environment. </li><li> Experience with cross-functional stakeholder engagement and governance processes. </li><li> Willingness to travel domestically and internationally as needed. </li></ul>The salary for this position is expected to range between $152,600.00 and $283,400.00 USD per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Associate Director, Search & Evaluation

Summary The Downstream Manager, Manufacturing is responsible for organizing, managing, and continuously improving the manufacturing operations and process at a manufacturing site. About the Role Location: This position will be located in Durham, NC and will be an On-Site role. Key Responsibilities: <ul><li> Leads a team of Manufacturing Associates whose direct responsibilities include producing product on the manufacturing floor. </li><li> First line of contact to handle process and equipment deviations on the floor. Areas of responsibility could include upstream (cell culture), downstream (Purification), and/or fill/finish activities as well as media and buffers. </li><li> Produces clinical and commercial material on an annual basis that meets the site's strategic objects and is compliant with cGMPs and safety regulations. </li><li> Accountable for performance in their area </li><li> Sets vision, strategy and goals for their area. </li><li> Accountable to have leader standard work for Supervisors and ensure activities are manageable within normal scheduled work hours. </li><li> Proactively identifies risks to achieving goals and mitigates them. </li><li> Creates environment where org can successfully achieve their goals, equally on all shifts. </li><li> Partners with support groups to address issues safely, compliantly and effectively. </li><li> Ensures documentation (batch records and SOPs) are accurate and updated as required. </li><li> Participates in tours or information requests for all agency and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure. </li><li> Provides monthly manufacturing metrics as determined by management. </li><li> Leads areas of tech transfer of new products and processes into the manufacturing area. Provide manufacturing feedback on engineering related projects. </li><li> Identifies and implements continuous improvement opportunities. </li><li> Leads and mentors staff. Write performance reviews and annual goals, hold one-on-ones, and handle HR related matters. </li><li> Other related duties as assigned. </li></ul> Essential Requirements: <ul><li>B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.</li><li>Prior management experience.</li><li>5 years of experience in biopharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification (TFF, chromatography), aseptic fill/finish with:<ul><li>Solid knowledge of FDA regulations and GMP systems</li><li>Excellent oral and written communication skills.</li><li>Strong technical writing ability.</li><li>Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence. </li><li>Demonstrated leadership skills.</li></ul></li><li>Experience in strategic/tactical planning, team building, and meeting budgets.</li></ul>Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $103,600 and $ 192,400 annually. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. #LI-Onsite Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Downstream Manager, Manufacturing

Summary The Drug Product Manager, Manufacturing, is responsible for organizing, managing, and continuously improving the manufacturing operations and process at a manufacturing site. About the Role Location: This position will be located in Durham, NC and will be an On-Site role. Key Responsibilities: <ul><li> Leads a team of Manufacturing Associates whose direct responsibilities include producing product on the manufacturing floor. </li><li> First line of contact to handle process and equipment deviations on the floor. Areas of responsibility could include upstream (cell culture), downstream (Purification), and/or fill/finish activities as well as media and buffers. </li><li> Produces clinical and commercial material on an annual basis that meets the site's strategic objects and is compliant with cGMPs and safety regulations. </li><li> Accountable for performance in their area </li><li> Sets vision, strategy and goals for their area. </li><li> Accountable to have leader standard work for Supervisors and ensure activities are manageable within normal scheduled work hours. </li><li> Proactively identifies risks to achieving goals and mitigates them. </li><li> Creates environment where org can successfully achieve their goals, equally on all shifts. </li><li> Partners with support groups to address issues safely, compliantly and effectively. </li><li> Ensures documentation (batch records and SOPs) are accurate and updated as required. </li><li> Participates in tours or information requests for all agency and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure. </li><li> Provides monthly manufacturing metrics as determined by management. </li><li> Leads areas of tech transfer of new products and processes into the manufacturing area. Provide manufacturing feedback on engineering related projects. </li><li> Identifies and implements continuous improvement opportunities. </li><li> Leads and mentors staff. Write performance reviews and annual goals, hold one-on-ones, and handle HR related matters. </li><li> Other related duties as assigned. </li></ul> Essential Requirements: <ul><li>B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.</li><li>Prior management experience.</li><li>5 years of experience in biopharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification (TFF, chromatography), aseptic fill/finish with:<ul><li>Solid knowledge of FDA regulations and GMP systems</li><li>Excellent oral and written communication skills.</li><li>Strong technical writing ability.</li><li>Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence. </li><li>Demonstrated leadership skills.</li></ul></li><li>Experience in strategic/tactical planning, team building, and meeting budgets.</li></ul>Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $103,600 and $ 192,400 annually. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. #LI-Onsite Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Drug Product Manager, Manufacturing

Summary Location: East Hanover NJ, Cambridge MA or Basel Switzerland. If applying in Europe, please refer to REQ-10066636. LI-#hybrid The Strategy & Growth Portfolio Insights Forecasting team is seeking a new Director of Forecasting Excellence. This individual will oversee and assess transparent, evidence-based long-term forecasts and assumptions, including both modelling and the ability to generate and validate insights to support key assumptions, across the oncology solid tumor therapy area. The Director will also be able to synthesize key risk and opportunities in commercial assessments across programs and the portfolio. About the Role Key responsibilities: <ul><li> Is the subject matter expert in long-term revenue forecasting in Oncology Solid Tumor therapy area </li><li> Develops and maintains indication-specific and epidemiology-based sales forecasts for pipeline and in-market brands on both an as needed and evolving basis </li><li> Works collaboratively with the Strategy & Growth (S&G), US and International (INT) teams, as well as other cross-functional partners, to ensure market insights are integrated into forecasts, and US & INT numbers rolled into a single set of brand numbers </li><li> Coordinates with and obtains alignment from key stakeholders, including US & INT, on critical assumptions and generating and aligning on the treatment journey. </li><li> Identifies key risks and opportunities inherent in the forecast and employs appropriate methodologies for addressing and communicating these. </li><li> Monitors the industry to remain informed of best practices, identifies opportunities to leverage new techniques and technologies that will enhance modelling and forecasting capabilities </li><li> Consolidates and summarizes sales forecast assumptions, methodology, and results to all relevant systems and platforms </li><li> Provides forecast models, assumption guidance, and training to S&G, US, INT colleagues and priority country teams </li><li> Coaches and mentors junior colleagues </li></ul>Essential Requirements: Education:<ul><li>Bachelor's degree in Science/Economics/ Statistics/Engineering/Business/related field required; MBA or advanced degree in one or more fields strongly preferred.</li></ul>Languages:<ul><li>Fluent oral and written English, other language(s) are an additional asset</li></ul>Experience/Professional requirement:<ul><li>Minimum 7 years of experience in Biotech/Pharmaceutical industry, life sciences consulting with commercial assessment experience; in-market commercial, finance, or new product planning experience strongly preferred</li><li>Direct experience in assessing and forecasting oncology solid tumor projects</li><li>Familiarity with epidemiology sources, IQVIA, Evaluate Pharma, claims, and other standard pharmaceutical data</li><li>Experience incorporating big data analytics, competitive intelligence, primary & secondary market research into forecast models</li><li>Comfortable with identifying and implementing AI solutions where appropriate</li><li>Strong understanding of forecast methodologies, including expertise in patient-based forecast modelling, risk simulation (i.e. monte carlo)</li><li>Expertise in translating inputs from cross-functional business partners into forecast model assumptions</li><li>Demonstrated ability to work independently with minimal direction</li><li>Strong project management skills, with the ability to manage multiple projects simultaneously</li><li>Effective team building and consulting skills, with demonstrated ability to work collaboratively in cross-functional teams</li><li>Excellent written, verbal, and presentation skills</li></ul>Novartis Compensation Summary: The salary for this position is expected to range between $185,500.00 and $344,500.00 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Director, Forecasting Excellence

Summary The Scientist/Principal Scientist provides technical leadership and site support for current and future Quality Control operations within Novartis which may The Scientist/Principal Scientist provides technical leadership and site support for current and future Quality Control operations within Novartis which may include analytical method lifecycle management, including method transfer, development, qualification, validation, testing, release, troubleshooting, and specification strategy. This role supports new and ongoing project support for regulatory submissions, QC operations, and cross-functional initiatives across sites. Location: Durham #LI-Onsite This role is located on-site in Durham, NC. Novartis is unable to offer relocation support for this role; please only apply if this location is accessible for you. Shift: Monday-Friday, 1st - 2 positions About the Role Key Responsibilities: Technical Leadership & Method Lifecycle<ul><li>Lead method development, transfer, qualification, and validation (ICH/USP/EP).</li><li>Drive method optimization, technology scouting, and digitalization (e.g., LIMS, e-notebooks).</li><li>Manage method control, reference standards, and critical reagent programs.</li></ul>Project & Cross-Functional Support<ul><li>Collaborate with global AST, QC, site operations, QA, and Novartis stakeholders.</li><li>Support capacity planning, lab design, equipment strategy, and procurement.</li><li>Lead assay transfers, validations, verifications, and equipment qualifications.</li><li>Provide technical expertise for site planning beyond GTX as a project management support</li></ul>Quality & Compliance<ul><li>Author/review SOPs, URS, specifications, sampling plans, and validation protocols.</li><li>Own and lead GMP records such as Change controls, CAPAs, investigations, etc.</li><li>Ensure inspection readiness and alignment with quality systems.</li><li>Lead investigations, trend analyses, and continuous improvement (Lean/Six Sigma).</li><li>Maintain data integrity (ALCOA+), audit trails, and audit readiness.</li></ul>Laboratory & Equipment Oversight<ul><li>Partner with Engineering, Facilities, EHS, and vendors for lab setup and equipment commissioning (URS, FAT/SAT/IOQ).</li></ul>Regulatory & Documentation<ul><li>Support regulatory filings (IND/BLA), inspections, and responses.</li><li>Author and approve experimental protocols, reports, and submissions.</li><li>Represent QC/AST in cross-functional teams (CMC, Regulatory, Manufacturing).</li></ul>Team Leadership & Development<ul><li>May manage FTEs or contractors across multiple projects as project needs require.</li><li>Coach and develop staff; maintain training matrices and qualification plans.</li></ul>External Collaboration<ul><li>Oversee contract testing labs to ensure project success.</li><li>Drive supplier qualification and negotiate service agreements.</li></ul>Essential Requirements<ul><li> Education & Experience: <ul><li> BS in scientific discipline with 10+ years in biotech/pharma </li><li> MS with 8+ years or PhD with 6+ years relevant experience </li><li> 4+ years leadership experience preferred </li></ul></li><li> Technical Expertise: <ul><li> Strong background in analytical support for biologics </li><li> End-to-end method lifecycle experience </li><li> Proficiency in techniques: HPLC/UPLC, GC, LC-MS, ICP-MS, UV-Vis, FTIR, KF, TOC, NGS, STR, AA, rcAAV, raw materials, dissolution, titration, particle size, virology, biologics, osmolality; microbiology/EM as applicable </li><li> Experience with lab commissioning, equipment validation, and LIMS </li></ul></li><li> Regulatory & Quality Systems: <ul><li> Familiarity with cGMP/GLP, data integrity, and audit processes </li><li> Experience with deviations, CAPA, change control, and document management </li><li> Regulatory filing and agency interaction experience </li></ul></li></ul> Preferred: <ul><li> Six Sigma/Lean experience </li><li> ISO 17025 familiarity </li><li> Project management and lab startup experience </li></ul> The salary for this position is expected to range between $98,700 and $183,300/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Scientist/Principal Scientist Quality Control

Summary This position will be located at the East Hanover, NJ site and will not have the ability to be located remotely. This position will require 20% travel as defined by the business (domestic and/ or international). The Director, NPS Lifecycle Management and Process Transformation is responsible for life cycle planning for in-line patient support programs and will develop deep forward-looking planning and right-sizing of our programs after launch to LoE. This individual will need to collaborate with the NPS Competitive Intelligence team to understand the external competitive environment and our internal product/portfolio strategies. This role ensures our Disease State teams are in a constant state of readiness to anticipate and act on external macro-environmental market changes, competitor new launches and other competitor strategies in a legal and compliant manner. This individual will work closely with NPS Vendor Management, NPS Competitive Intelligence, Disease Area & Product, Quality, Enterprise Content Design as well as Finance and Compliance partners. The role includes overseeing the implementation of a lifecycle management framework, integrating patient services into in-line programs, and leading strategic patient support initiatives. The Director stays at the forefront of trends by demonstrating thought leadership in personalized, technology-driven patient support, ensuring a patient-first approach in redefining industry standards for patient-centric care. About the Role Key Responsibilities: <ul><li>Lead the strategic planning for lifecycle management across the Therapeutic Area portfolio.</li><li>Develop and implement focused strategies for brand performance by evaluating insights, category trends, in-market performance, and competitive activity.</li><li>Collaborate with cross-functional teams to develop an LCM framework for key products through active involvement in Governance Framework such as CCRB, Quantum, and PSOC.</li><li>Oversee the optimal rollout and implementation of the LCM framework, including training where needed, to integrate Patient Services offerings for in-line programs. This includes components such as Copay, Free Goods, Patient Hubs, Clinical Support, Digital Solutions, and E-services.</li><li>Develop effective patient support program strategies for in-line products, new indications, and Loss of Exclusivity (LoE).</li><li>Utilize competitive intelligence to provide unbiased, fact-based cross-functional strategies and prioritize resources effectively.</li><li>Collaborate cross-functionally to develop strategies that reduce spend and reallocate resources as the Patient Support Program matures. Ensure resource optimization and cost management to maintain high efficiency and effectiveness in patient support initiatives.</li><li>Oversee the Quantum Portfolio Management (QPM) role, to ensure strategic initiatives are prioritized across the NPS roadmap and implemented accordingly.</li><li>Ensure Business Excellence assets (workflows, business requirement documents (BRD) and user acceptance testing (UAT) are maintained and executed.</li><li>Monitor testing for system release via offshore resources. Develop and maintain Process maps, and BRDs. Maintain support Mature products Portfolio</li></ul>Essential Requirements: <ul><li>Education: Bachelor's degree required, Advanced degree (MA, MS, MBA) preferred.</li><li>Minimum of 10 years of experience within the US healthcare sector, including significant roles in consulting at biopharmaceutical companies.</li><li>Broad experience across various disciplines/functions such as commercial, marketing & sales, regulatory compliance, payors, providers, manufacturing, and quality. Demonstrated expertise in patient support disciplines/functions.</li><li>Proven success in leading and managing cross-functional strategic projects with substantial business impact, showcasing the ability to drive organizational change. Exceptional strategic planning, organizational, and communication abilities with a proven track record in problem-solving and escalation resolution.</li><li>Extensive experience in senior stakeholder management, adept at effectively engaging and managing associates across diverse backgrounds and functions within a complex, matrixed organization.</li><li>Strong capability to influence and drive decisions without direct authority, coupled with exceptional communication skills and proficiency in leading meetings with senior management.</li><li>Skilled in developing forward-looking plans and right-sizing programs from launch through Loss of Exclusivity (LoE).Demonstrated ability to anticipate and adapt to market changes and competitive launches, maintaining legal and regulatory compliance.</li><li>Proven experience in driving process standardization and transformation initiatives, maintaining high standards of efficiency and effectiveness.</li><li>Expertise in developing and implementing lifecycle management frameworks and patient support program strategies.</li><li>Superior problem-solving skills combined with strong interpersonal abilities to effectively convey strategic needs and directives to teams, colleagues, and functions throughout the organization. Demonstrated expertise in managing teams to deliver process improvement initiatives, achieving enhanced operational efficiency and productivity.</li><li>Prior people leadership experience is preferred</li></ul>The pay range for this position at commencement of employment is expected to be between $185,500 and $344,500 per year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Director, NPS Lifecycle Management and Process Transformation

Summary Location: #LI-Onsite Job Description Summary The Insights and Decision Science (IDS) team is dedicated to enabling improved decision making at Novartis by lever-aging data and advanced analytics capabilities to generate actionable insights that drive business growth. We collab-orate closely with the US business, bringing insights and challenging ideas to empower smarter, data-driven decision-making. Reporting into the ED, Integrated Field Insights & Analytics, the Manager, Integrated Field Insights & Analytics (FIA) will play a pivotal role in supporting agile delivery execution across multiple therapeutic areas (TAs), coordinating cross-functional initiatives, and driving project management excellence across the portfolio. This role is de-signed to enhance operational efficiency and strategic alignment within the FIA team, contributing to the broader goals of the IDS organization. This position will be located at the East Hanover, NJ site and will not have the ability to be located remotely. This position will require 10% travel as defined by the business (domestic and/ or international). About the Role Key Responsibilities: Agile Delivery Execution<ul><li>Lead and facilitate agile workflows across FIA squads and cross-functional teams, ensuring consistent delivery cadence and backlog prioritization.</li><li>Champion continuous improvement by identifying process inefficiencies and implementing agile best practices across squads.</li><li>Facilitate sprint planning, retrospectives, and delivery tracking.</li><li>Mentor team members on Agile principles and practices.</li></ul>Coordination & Communication<ul><li>Act as a central coordination hub for TA-specific initiatives, ensuring seamless collaboration and stakeholder alignment.</li><li>Develop and maintain stakeholder maps and communication plans to ensure clarity of roles, responsibilities, and expectations.</li><li>Ensure timely communication and alignment between stakeholders, including EDs, Directors, and cross-functional partners.</li></ul>Project Management<ul><li>Manage cross-portfolio projects from initiation to completion.</li><li>Develop and maintain project plans, timelines, and deliverables.</li><li>Drive portfolio-level prioritization and resource alignment in collaboration with IDS leadership and TA partners.</li><li>Adapt project plans and methodologies needed to meet evolving requirements.</li><li>Manage project backlogs and scope.</li><li>Continuously monitor progress, proactively identify risks or blockers, and implement mitigation strategies.</li></ul>Strategic Support<ul><li>Provide operational and analytical support to Therapeutic Area (TA) -specific squads.</li><li>Translate field insights into actionable recommendations that inform TA strategy and commercial decision-making.</li><li>Contribute to the development and execution of strategic plans, roadmaps, and performance metrics aligned with IDS objectives.</li></ul>Documentation & Reporting<ul><li>Ensure documentation integrity and consistency across FIA repositories including SharePoint, Smart Sheets, and JIRA.</li><li>Establish and enforce version control and governance standards for documentation and reporting assets.</li><li>Support reporting needs for leadership and cross-functional reviews.</li><li>Create dashboards and reports to update leadership on Epics/Programs/Projects status.</li></ul>Education: Bachelor's degree in Business, Life Sciences, Data Analytics, or related field; Master's preferred. Essential Requirements:<ul><li>Minimum 5+ years of experience in project management, analytics, or operations within pharma or healthcare.</li><li>Demonstrated expertise in agile methodologies, including Scrum or SAFe, and experience navigating cross-functional team dynamics.</li><li>Excellent communication, organizational, and stakeholder management skills.</li><li>Proficiency in project management tools and Microsoft Office Suite.</li></ul>Desirable Requirements:<ul><li>Experience working in field insights, analytics, or commercial operations.</li><li>Familiarity with therapeutic area-specific strategies and data-driven decision-making.</li><li>Prior experience in leading agile delivery model implementations and managing enterprise-level project coordination.</li><li>PMO experience and PMP certification preferred; Agile certifications (e.g., Certified Scrum Master, SAFe Agilist) are a plus.</li></ul>The salary for this position is expected to range between $119,700.00 and $222,300.00 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Manager, Integrated Field Insights & Analytics

Job Description This is a hands-on pipeline project facing opportunity to be the primary day-to-day RCMCS lead to develop study design (DOE), statistical analysis, and reported output using in-house developed JMP tools in fast-paced, critical path projects. You will participate on process characterization teams to understand requirements to design study experiments and discuss results. Experiment design entails having joint conversations with the Process scientists/engineers to discuss the issues and constraints on study design and execution, working with Process Scientists/Engineers to complete study reports as needed. Work with and mentor junior statisticians. In addition to pipeline project responsibilities, there will be an abundance of opportunity to pursue applied statistics research problems to address critical business needs. Your passion for DOE and statistical modelling will drive you to mentor, teach, and innovate to address business critical problems. Education and Minimum Requirement Masters in statistics/biostatistics a minimum of 6 years relevant work experience, or PhD or equivalent degree with a minimum of 3 years relevant work experience. Required Skills and Experience:<ul><li>Proven experience applying and teaching DOE in real-life process development problems working with scientists/engineers.</li><li>Proven knowledge of statistical analysis methodologies and experimental design (e.g., Split-Plot, DSD, OMARS, Optimal).</li><li>Proven hands-on experience with JMP and working knowledge of other statistical and data processing software (e.g., Design Expert, Minitab, R, Python)</li><li>Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution often under accelerated timelines.</li><li>Strong oral and written communication skills to be able to function and lead effectively in a team environment.</li><li> Must be able to work effectively if remote work is required. </li></ul> #eligibleforERP Required Skills: Business Administration, Communication, Data Analysis, Data Management, Data Science, Numerical Analysis, Oral Communications, Pipeline Management, Process Characterization, Process Consulting, Remote Workforce, Research Designs, SAS JMP (Statistical Software), Scientific Modeling, Scientific Study Design, Statistical Analysis, Statistical Theory, Statistics, Waterfall Model, Written Communication Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $139,600.00 - $219,700.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 11/18/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R374092

Associate Principal Statistician, CMC

Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! The Senior Specialist, Engineer is a member of the Engineering team providing technical support within a new therapeutic manufacturing facility located in Durham, North Carolina. The new facility includes end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse. The candidate will be responsible/support the reliability, operation, and maintenance of HVAC, and clean utility equipment and systems (WFI, Clean Steam, HVAC, and CDA), utility equipment and systems (Boilers, Chillers, etc) to ensure proper functionality of manufacturing equipment such as washers, autoclaves, filling line, lyophilizers and isolators. The successful candidate will also develop Standard Operating Procedures (SOPs), Preventative Maintenance (PM) plans as necessary and responsible for supporting root cause investigations and change control activities. Key Duties: <ul><li> Responsible for the maintenance and reliability of Clean Utility Equipment (e.g. HVAC, Clean steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems) </li><li> Leads deviation investigations for HEPA and HEPA system failures, ensuring events are well-investigated and well-documented, while meeting timing commitments </li><li> Manages small projects for equipment/maintenance-related improvements, including obtaining quotes, drawing/specification review/approval, and review of contracts </li><li> Interact with vendors and support project coordination activities like design reviews, and engineering assessments </li><li> Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units </li><li> Responsible for assisting in the identification, development, and implementation of new systems which enhance the operation and/or engineering processes. </li><li> Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges </li><li> Consults on an as-needed basis with next-level manager for newly identified priorities </li><li> Develops operating strategy from an Engineering / Maintenance perspective supporting site reliability initiatives </li></ul> Process Execution / Continuous Improvement: <ul><li> Oversee improvement projects and implementation of productivity enhancement initiatives. </li><li> Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment uptime, minimizing cost and maintaining process consistency </li><li> Anticipates and interprets client and/or customer needs to identify solutions </li><li> The successful candidate must have strong problem-solving skills and a hands-on approach to problem solving. </li></ul> Quality & Safety Compliance: <ul><li> Must be fully aware of requirement specifications from a qualification perspective (IC/OC, IQ/OQ, CRs, etc.) </li><li> The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and identify root causes. </li><li> Provide input to investigate deviations (both minor and major), with responsibility to interface with Operations, Maintenance, Automation, and Quality approvers. </li><li> As part of the deviation management role, present and defend investigations during regulatory inspections, as required. </li><li> Actively supports safety initiatives, including shop floor audits, lockout/tagout and Hazardous Energy Control Procedure updates </li></ul> Communication: <ul><li> Works as a liaison between Engineering, Maintenance, Production and other Site Business Partner's </li><li> Support daily meetings to facilitate flow of information up/down through the organization </li><li> Escalate issues as needed to ensure the right support/awareness is given to issues as they arise </li><li> Develop training material. Working as a subject matter expert (SME), provide necessary training for system maintenance. </li><li> Serve as a Subject Matter Expert during tours to provide area/process overview information to visitors/auditors upon request </li></ul> Financial: <ul><li> Ensure inventory/purchase order transactions are complete, timely, and accurate </li><li> Recognize and communicate opportunities for cost savings </li></ul> Education Minimum Requirement: <ul><li> Bachelor Degree in Engineering, Science and 6 years experience or a Master's Degree in Engineering, Science and 4 years experience in a production and/or calibration and/or maintenance background </li></ul> Preferred Experience and Skills: <ul><li> Proficient in PI Processbook, Siemens BAS, and DeltaV </li><li> Project management, including change control and equipment qualification </li><li> SAP experience related to plant maintenance and spare parts procurement systems </li><li> cGMP experience in a sterile, bulk or finished pharmaceutical environment </li><li> Experience authoring PM/calibration job plans and management of spare parts </li><li> Mechanical functionality and reliability knowledge (asset management) </li></ul>VETJOBS<ul></ul>Required Skills: Adaptability, Adaptability, Deviation Investigations, Engineering Process, Facility Management, Failure Mode and Effects Analysis FMEA, HVAC Systems, Identifying Customer Needs, Interpersonal Relationships, Lean Six Sigma Tools, Lockout Tagout, Manufacturing Quality Control, Pharmaceutical Microbiology, Plant Maintenance, Process Improvement Projects, Productivity Improvements, Project Coordination, Project Management, Regulatory Compliance, Regulatory Inspections, Root Cause Analysis (RCA), Steam Generators, Strategic Thinking, System Maintenance, Technical Writing {+ 1 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 11/28/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R372934

Senior Specialist, Engineering

Job Description Our Quality Assurance group ensures our products are manufactured, processed, tested, packaged, stored and distributed in alignment with our incredibly high standards of quality and meet all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The Quality Line Oversight Program at West Point is an entry level 2 year program with 8 month rotations focused on providing hands-on experience in pharmaceutical quality assurance supporting our Company's largest and most complex vaccine manufacturing plant site. This entry level program provides individuals with a range of experiences across several core quality functions fostering a foundational introduction to the vaccine manufacturing business. This multi-faceted program supports opportunities to learn, upskill, and gain meaningful experience across different parts of vaccine manufacturing, facilitating future career development and job opportunities. The successful candidate will be part of the Quality Line Oversight Program as a Quality Associate Specialist located at the West Point, PA site. In addition to hands-on shopfloor experience, the employees will be provided with an exciting opportunity to participate in a quality rotational program. This program is designed such that employees will be assigned with appropriate mentors within various key areas of the Quality organization as part of the rotation. The employees will be provided training and shadowing opportunities and will gain exposure to tasks within key areas of quality, providing the employee with a broad view of the work at West Point At the completion of the QLO program including the rotations, successful individuals will be assigned to a Quality or Operations Specialist role to further develop the individual's knowledge of the vaccine manufacturing business as well as help position them for future career growth. The targeted start date for this position will be in Feb 2026 and Dec 2026. The QLO Associate Specialist position is a direct manufacturing support role primarily on the shop floor within our Quality Line Oversight team. This team rotates through the vaccine filling and packaging departments at the West Point site providing quality and compliance oversight to our 24/7 manufacturing operations. Primary responsibilities involve:<ul><li>Quality checks of finished product including visual inspection of vials, syringes and packages</li><li>Verification of appropriate line clearance between batches to prevent product mix-ups</li><li>GMP document / batch record review</li></ul>Additional responsibilities include:<ul><li>Rotational support of Quality Assurance, Quality Operations, and Environmental Monitoring providing a foundational understanding of vaccine Quality oversight and production.</li><li>Continuous improvement projects by participating in problem solving and partnering with Operations, Technology, and/or other Quality groups in areas such as safety, quality, and efficiency</li></ul>The shift structure for the position includes 12-hour day and night shifts which rotate approximately every 9 weeks. The position does require weekend coverage. Both the initial QLO assignment and future opportunities can include off-shift/off-schedule support within a vaccine manufacturing operations area. This is an entry level position, and 0-2 years of experience in pharmaceutical industry through internships, co-operative education or other roles is preferred. GENERAL PROFILE:<ul><li>Contributes to the performance and results of a vaccine manufacturing department.</li><li>Provides regulatory, quality and compliance guidance.</li></ul>BUSINESS EXPERTISE:<ul><li>Applies technical, collaboration and interpersonal skills to align activities with department objectives.</li></ul>FUNCTIONAL EXPERTISE:<ul><li>Works as a team member on shop floor core tasks, quality systems activities and/or process improvement projects.</li><li>Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.</li><li>Assures consistent application of standardized work, process tools, and procedures.</li><li>Assists with regulatory inspections in either documentation area, request management area or inspection room.</li><li>Provides quality guidance to technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.</li><li>Effectively collaborates with peers on site and above site as required.</li></ul> Education Minimum Requirement: <ul><li>Bachelor's Degree in Engineering or Sciences</li></ul> Required Experience and Skills: <ul><li>Willing to work alternate shifts and weekends.</li><li>Ability to focus on and obtain results</li><li>Good verbal and written communication skills</li><li>Ability to effectively collaborate within and across an integrated manufacturing team</li><li>Ability to enact conflict resolution</li><li>Ability to effectively respond to change</li><li>Excellent analytical and organizational skills</li><li>High personal integrity, credibility and energy</li><li>Flexibility to perform related tasks to support the business</li><li>Computer literacy in MS Office, Word, Outlook, Excel</li></ul> Preferred Experience and Skills: <ul><li>0-2 years working experience in cGMP pharmaceutical environment</li><li>Experience using Lean/Six Sigma tools</li></ul>FTP2026 FTJobs MD2026 Required Skills: Accountability, Accountability, Analytical Problem Solving, Aseptic Filling, cGMP Compliance, Collaborative Communications, Complaint Management, Compliance Oversight, Continual Improvement Process, Decision Making, Deviation Management, Good Manufacturing Practices (GMP), IS Audit, Pharmaceutical Quality Assurance, Pharmaceutical Quality Control (QC), Process Improvement Projects, Quality Assurance (QA), Quality Assurance (QA) Standards, Quality Auditing, Quality Management, Quality Management Standards, Quality Management Systems (QMS), Quality Operations, Quality Standards, Quality Support {+ 4 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $70,500.00 - $110,900.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 12/12/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R372152

2026 Future Talent Program - Assoc. Spclst, Quality Assurance

Job Description Technician O2 is a skilled technician with a moderate level of industry experience, responsible for performing routine operational and maintenance activities within an assigned suite or area. This role requires proficiency in mechanical and technical tasks, adherence to current Good Manufacturing Practices (cGMP), and a commitment to environmental, health, and safety (EH&S) standards. The Technician O2 works with moderate supervision, demonstrates mechanical aptitude, and actively contributes to team performance and process improvements. Key Responsibilities<ul><li>Operational Proficiency:<ul><li>Fully qualified to independently operate within the assigned suite or area</li><li>Performs all routine operational activities and preventative maintenance tasks independently. </li><li>Demonstrates mechanical aptitude and executes basic repairs for assigned equipment;</li></ul></li><li>Compliance and Documentation:<ul><li>Takes ownership of cGMP compliance, ensuring adherence to Standard Operating Procedures (SOPs), maintenance task lists, and proper documentation.</li><li>Proactively identifies and resolves compliance issues in the assigned suite, escalating to O3 or O4 levels when necessary.</li><li>Maintains 100% training status without requiring coach input.</li></ul></li><li>Business Systems Proficiency:<ul><li>Proficient in business systems such as SAP, SAP Mobile, DeltaV, and other relevant platforms, performing tasks and transactions independently with minimal assistance.</li></ul></li><li>Problem Solving and Process Improvement:<ul><li>Recognizes operational and technical problems, using established procedures to assess and implement solutions.</li><li>Performs routine troubleshooting for assigned equipment or systems, escalating complex issues to higher-level technicians (O3/O4) as needed.</li></ul></li><li>EH&S and Team Accountability:<ul><li>Contributes to maintaining positive EH&S performance in the assigned area, actively identifying and resolving potentially unsafe conditions.</li><li>Demonstrates inclusion principles, collaborates with team members, and actively participates in team meetings, including Tier discussions.</li><li>Complies with safety and environmental regulations and guidelines.</li></ul></li><li>Work Management and Prioritization:<ul><li>Works independently to meet timeframes set by others, demonstrating reliability and follow-through on commitments.</li><li>Acts with urgency for emerging issues as directed by leadership.</li></ul></li><li>Leadership and Communication:<ul><li>Provides and receives timely, constructive one-on-one feedback to improve performance.</li><li>Listens, collaborates, and supports team decisions to meet collective goals.</li></ul></li><li>Additional Duties:<ul><li>Communicate with other departments, contractors, or disciplines</li><li>Assists with automation, validation, and additional testing as required.</li><li>Contributes to Continuous Improvement of existing processes</li><li>Complies with safety and environmental regulations and guidelines.</li><li>Other tasks that may be assigned by leadership</li></ul></li></ul>Minimum Required Education<ul><li>High School Diploma or GED</li></ul>Required Experience and Skills<ul><li>Minimum 3 years of plant maintenance or technical experience.</li><li>Proficiency in one of the technical craft skills, including instrumentation, electrical, plumbing, or advanced mechanical systems.</li><li>Familiarity with regulatory requirements in accordance with cGMP manufacturing operations or other regulated industry.</li><li>Effective communication skills, both written and oral.</li><li>Ability to work with moderate supervision in non-routine situations.</li></ul>Preferred Experience and Skills<ul><li>Associate Degree in Industrial Systems, Mechanical, Electronics, Electrical, Instrumentation, or Military Training</li><li>Familiarity with automated process equipment in the biopharmaceutical field.</li></ul><ul><li>Experience with SAP, SAP Mobile, DeltaV, and CMMS Calibration/Maintenance Database Systems..</li></ul>Physical Requirements<ul><li>Ability to lift 50 pounds, climb ladders and stairs, and work on platforms and equipment above floor level.</li><li>Requires walking, bending, crawling, and stooping.</li><li>Must wear personal protective equipment, including safety glasses, earplugs, gloves, hard hats, and safety harnesses.</li><li>Position requires clean room gowning during performance of job duties.</li></ul>Work Schedule<ul><li> All shifts</li></ul>VETJOBS MSJR SKILLEDLABORUS Required Skills: cGMP Compliance, Current Good Manufacturing Practice (cGMP), Electrical Maintenance, Equipment Troubleshooting, Field Failure Analysis, Good Manufacturing Practices (GMP), Maintenance Operations, Manufacturing Operations, Mechanical Engineering, Mechanical Maintenance, Plant Maintenance, Pneumatics, Preventive Maintenance, Production Scheduling Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day, 2nd - Evening, 3rd - Night Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 12/5/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R374447

Maintenance Technician All Shifts

Job Description Elkton GES Project Delivery Leader, Director Our company's Global Engineering Solutions (GES) is seeking a highly motivated and experienced Project Delivery Leader to oversee the design, construction, installation, commissioning, and startup of a Drug Substance and Drug Product Facilities. This on-site Director role is based in Elkton, Virginia, and offers a unique opportunity to contribute to one of the most significant investments in Our company's human health manufacturing infrastructure in the United States. You will work alongside top-tier engineering, construction, and operational teams to deliver world-class capabilities. About the Project Our company is launching a major capital expansion at its Elkton, Virginia, site, a Center of Excellence for Pharmaceutical Manufacturing. This $3 billion investment will add approximately 400,000 square feet of state-of-the-art facilities, spanning both Active Pharmaceutical Ingredient (API) and Drug Product capabilities to support small molecule manufacturing and testing. This expansion advances our mission to deliver innovative treatment options for people facing serious health challenges in the U.S. and around the world. Primary Responsibilities include, but are not limited to: <ul><li> Champion a strong safety culture. Ensure projects meet or exceed company EHS targets. </li><li> Ensure compliance with company Standards, Procedures, and the company Quality Manual. </li><li> Broad knowledge of the biopharmaceutical industry across multiple project types: drug substance, drug product, labs, large and small molecule, clean utilities, centralized utilities (steam, chilled water, electrical, etc.). </li><li> Foster collaboration with Our company's Leadership, Site Stakeholders, Partners, and cross-functional teams. </li><li> Apply Lean Project Delivery best practices and continuous improvement, update standard work. </li><li> Effective communication and people skills to interface effectively with all levels of colleagues in a team environment. </li><li> Provide leadership: Manage and coach team members; set clear business priorities and behavior expectations. </li><li> Candidate must live within or relocate to Elkton, VA vicinity. </li><li> Initial assignment will involve less than 10% travel. Long term must have ability to travel up to 50% of time. </li></ul> Safety <ul><li> Process safety: establish HAZID/HAZOP, and PSSRs to identify hazards early. </li><li> Construction safety: implement safety plans, toolbox talks, audits, etc. to sustain a target zero" culture. </li><li> Site logistics: develop site logistics plans that prioritize safety and maximize productivity </li></ul> Quality <ul><li> Establish and manage quality program. Design and construction quality assurance and control. </li></ul> Core and Steering <ul><li> Lead the Capital Governance process to control scope and meet business goals. </li><li> Run Tier/Safety/Staff meetings; manage stakeholder relations. </li><li> Define optimal execution strategies considering complexity, geography, risk, and business impact. </li></ul> Schedule planning <ul><li> Own integrated schedules from Business Case through first product manufacture and closeout. </li><li> Drive resource planning and workload projection. </li><li> Develop site logistics and permitting strategies to keep schedule on track. </li></ul> Procurement planning <ul><li> Coordinate sourcing and contracting strategies for design, construction, and critical vendors. </li></ul> Risk Management <ul><li> Maintain a portfolio risk register and mitigation plans. </li><li> Ensure quality control/assurance programs are in place and effective. </li><li> Guide teams to simple, robust solutions while integrating compliance, permitting, and logistics risks. </li></ul> Change Management <ul><li> Enforce governance rigor to control scope, cost, and schedule changes. </li><li> Lead funding review processes; approve packages; align stakeholders. </li></ul> TVD (Target Value Delivery) <ul><li> Apply Lean Project Delivery and Target Value Delivery principles to align scope, cost, and value to business outcomes. </li><li> Coach teams in lean construction behaviors. </li></ul> Front End Loading (FEL) nodes <ul><li> Support early FEL definition; lead final funding and Stage Gate reviews. </li></ul> Planning/last planner <ul><li> Deploy Last Planner System for reliable workface planning. </li><li> Improve look-ahead planning with partners. </li></ul> Progress/productivity analysis, action recovery <ul><li> Use dashboards/KPIs for safety, quality, cost, schedule, and productivity progress. </li><li> Conduct regular earned value, productivity and progress reviews; analyze variances and implement recovery plans. </li><li> Track commissioning, qualification, and turnover readiness. </li></ul> Education Minimum Requirement: <ul><li> Bachelor's degree in engineering </li><li> Minimum of ten (10) years of Project Management experience in pharmaceutical or highly regulated manufacturing environments. </li></ul> Required Knowledge and Experience: <ul><li> Pharmaceutical manufacturing experience (drug substance, drug product, labs, large and small molecule, utilities) </li><li> Deep understanding of cGMP and regulatory qualification requirements </li><li> Commissioning and qualification experience </li><li> Proven project management experience; PMP or equivalent preferred </li><li> Portfolio/program management; ability to build and lead diverse, high-performing technical teams. </li><li> Proven ability to navigate complex challenges, manage change, and drive project success under tight deadlines. </li><li> Expertise in Lean Project Delivery (Target Value Delivery, Last Planner, Takt planning) </li><li> Familiarity with modular/offsite construction </li><li> Proficiency in scheduling, cost control, and project controls. </li><li> Demonstrated use of BIM. </li><li> Coaching and mentoring capability. </li></ul>Required Skills: Accountability, Accountability, Biopharmaceutical Industry, Biopharmaceuticals, Capital Management, Change Management, Chemical Process Development, Coach Team Members, Cost Management, Cross-Cultural Awareness, Cross-Functional Leadership, Decision Making, External Manufacturing, GMP Compliance, Innovation, Leadership, Lean Process Improvements, Manufacturing Scale-Up, Pharmaceutical Manufacturing, Planning, Planning Process, Portfolio Risk, Portfolio Risk Management, Process Improvements, Project Delivery {+ 7 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $169,700.00 - $267,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 11/22/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R374089

Elkton GES Project Delivery Leader, Director

Job Description Translational Medicine in our Research & Development Division is responsible for planning and management of an important inflection point in the drug development process, working closely with scientific, regulatory, statistical, and modelling colleagues across the organization to translate the benchtop science of preclinical discovery into compounds ready for assessment in large clinical populations. We are seeking a highly qualified physician-scientist with a proven track record in the pharmaceutical industry as well as independent academic research for a position in our group. The preferred candidate will have at least 5-year experience in the pharmaceutical industry and Immunology R&D and clinical and academic expertise in Immunology-related areas such as Dermatology, Rheumatology, or Gastroenterology. For our efforts supporting the Immunology development pipeline, our closest collaborations are with groups-based Boston MA but will be open to other locations in West Point PA, Upper Gwynned, PA, Rahway, NJ, or San Francisco, CA. Translational Medicine is specifically responsible for:<ul><li>Contributing to the identification of novel targets by partnering with discovery research teams to bring a clinical insight into the earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of potential targets to human disease in order to justify investment in full development</li><li>Development of biomarker strategies through cross-functional teams that provide line-of-sight from First-in-Human studies through clinical Proof-of-Concept. This includes Experimental Medicine studies to establish and/or validate novel clinical biomarker platforms.</li><li>Development and execution of the early clinical development strategy for novel therapy/Immunology programs from Preclinical Candidate approval through clinical Proof-of-Concept (Phase 2a), and development and execution of clinical pharmacology strategies for late-stage development programs from Proof-of-Concept (Phase 2a) through worldwide marketing application.</li></ul>Success depends on the integrity, knowledge, imagination, creativity, skill, diversity, and teamwork of the people in the group. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of the global team, you will collaborate with talented and dedicated colleagues in Translational Medicine, as well as Discovery Sciences and late-stage Clinical Research while developing and expanding your career. This role will report directly to the Immunology Therapeutic Area Lead in Translational Medicine. Primary responsibilities for the Senior Principal Scientist include the following:<ul><li>Key member of an early development team, providing leadership in designing and executing early clinical development strategy</li><li>Development and execution of early clinical strategy for novel Immunology assets and therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for Preclinical Candidate molecules, Phase 1a/b trials and and clinical pharmacology studies for programs in Phases I through IV of development.</li><li>Development and execution of studies to validate clinical platforms utilizing established and novel biomarkers, including imaging, responses to interrogate biological activity in humans.</li><li>Provide clinical expertise for identification and validation of novel targets, including the design of preclinical and/or clinical pharmacology experiments to validate targets and/or pathways</li><li>Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations)</li><li>Provide clinical pharmacology support for programs through the worldwide marketing application filing including supportive registration documents and presentations</li><li>Provide clear, timely communication and interpretation of study results to therapeutic area governance, functional area experts and development review committees.</li><li>Contribute to assessment of internal and external opportunities identified by Business Development and Licensing</li><li>Interface broadly with key functions including Discovery Sciences, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research throughout sites in the USA, UK and Belgium.</li></ul> Position Qualifications : Education Minimum Requirement<ul><li>MD or MD/PhD with at least 5-year experience in the pharmaceutical industry in clinical research, or PhD with at least 10-years experience in clinical research or development</li><li>An educational/career track including both independently conceived and executed research and clinical patient care experience</li></ul>Required Experience and Skills:<ul><li>Proven track record in clinical research in the pharmaceutical industry</li></ul><ul><li>Proven track record in clinical care of patient populations or management of clinical problem-solving, preferably in Dermatology</li><li>Demonstrated record of scientific scholarship and achievement. Research expertise in any immunology field is preferred.</li><li>Strong interpersonal, writing and presentation skills, as well as the ability to function in a team environment are essential.</li><li>Board Certification or Eligibility (MD and MD/PhD) preferred</li></ul>Required Skills: Academic Research, Clinical Development, Clinical Immunology, Clinical Judgment, Clinical Medicine, Clinical Research Management, Clinical Trial Development, Clinical Trials, Drug Development, Immunology, Intellectual Curiosity, Pharmaceutical Industry, Scientific Research, Translational Research Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $206,200.00 - $324,600.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 11/18/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R373632

Senior Principal Scientist, Translational Medicine, Immunology

Job Description Be a part of the legacy: Postdoctoral Research Fellow Program Our Research Laboratories' Postdoctoral Research Fellow Program aims to be a best-in-industry program for industrial postdoctoral researchers, designed to provide you with an academic focus in a commercial environment. With the resources, reach, and expertise of a large pharmaceutical company, postdoctoral researchers will be positioned to excel in an institution committed to breakthrough innovation in research and discovery. Postdoctoral Researcher- Integrative Multi-Omics Causal Modeling (Genetics, Genomics) We are seeking a highly motivated and innovative postdoctoral researcher to join the Data, AI and Genome Sciences (DAGS) department to develop and apply cutting-edge computational and statistical methods for drug target discovery through multi-omics integration. The project will develop genetics-informed causal modeling frameworks by integrating human genetics and genomics data with perturbation-based sequencing datasets. This unique collaborative role between the Precision Genetics and Genome Sciences groups within DAGS aims to uncover causal gene-pathway-disease relationships, illuminate disease mechanisms, and advance translational research across multiple therapeutic areas. Key Responsibilities <ul><li>Develop scalable and robust statistical and computational methods for causal modeling by integrating human genetics, genomics and perturbation datasets.</li><li>Build computational pipelines for genetic association analyses, cell-disease interaction modeling, perturbation-informed pathway and network inference etc.</li><li> Apply causal inference and network approaches to infer gene to pathway to phenotype relationships to uncover causal molecular mechanisms. </li><li> Continuously track cutting-edge computational and statistical methods in statistical genetics and computational biology, and proactively propose and pilot innovative ideas and approaches. </li><li> Collaborate closely with wet-lab scientists and cross-functional computational teams. </li><li>Communicate findings effectively through publications, presentations, and collaborative meetings.</li></ul> Qualifications Required Qualifications <ul><li>Candidates must currently hold a Ph.D or Ph.D. completed within 6 months of hire in Statistics, Biostatistics, Computer Science, Mathematics, Statistical Genetics, Computational Biology, Bioinformatics, or a related quantitative field.</li><li>Demonstrated experiences analyzing large-scale genomics datasets, such as RNA seq, single cell RNA seq, proteomics etc.</li><li>Hands-on experience applying and/or developing statistical genetics methods such as GWAS, QTL mapping, variant-set association tests, polygenic scores, and heritability estimation etc.</li><li>Proficient programming skills in R and/or Python for data analysis, statistical modeling, and pipeline development. Familiarity with cloud platforms or HPC environments, with experiences on parallel computing and scalable workflow design. </li><li>Familiarity with causal inference methods, network/graphical models, or machine-learning approaches applied to genomics.</li><li>Ability to work independently and collaboratively in a multidisciplinary team environment.</li><li> Excellent written and oral communication skills, with a demonstrated ability to publish methodological papers or innovative applications in statistical genetics or computational biology. </li></ul> Preferred Qualifications <ul><li> Prior experience with perturbation sequencing assays (CRISPR screens, Perturb-seq, Drug-seq) and analysis of perturbation data. </li><li> Experiences in integrating multiple omics data types (e.g., genetics, single cell RNA seq etc.) </li><li> Experience with Bayesian modeling, graphical models, or causal discovery algorithms. </li><li> Experience working with large-scale biobank (UK Biobank etc.) or consortium datasets and secure research environments (TREs, DNAnexus etc.). </li></ul> postdoctoralopportunities Required Skills: Accountability, Accountability, Adaptability, Analytical Chemistry, Bayesian Statistics, Bioinformatics, Biological Sciences, Biostatistics, Cell Culture Techniques, Computational Biology, Computer Science, Data Analysis, Immunoassays, In Vivo Mouse Models, Mathematical Biology, Molecular Biology, Multidisciplinary Collaboration, Parallel Computing, Parasitology, Pipeline Development, Programming Languages, RNA Sequencing, Scientific Research, Scientific Writing, siRNA Knockdown {+ 4 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 12/6/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R372225

Associate Scientist, Postdoctoral Fellow - Integrative Multi-Omics Causal Modeling (Genetics, Genomics)

Job Description Welcome to the Future of Precision Oncology - Join Us in Wilmington, DE! We're thrilled to announce the launch of our cutting-edge Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, Delaware-a bold step forward in transforming cancer care through innovation, collaboration, and purpose-driven science. ADCs represent one of the most exciting frontiers in biopharmaceuticals today. By combining the targeting power of monoclonal antibodies with the potency of cytotoxic drugs, ADCs deliver cancer-killing agents directly to tumor cells, minimizing damage to healthy tissue. This precision has revolutionized treatment for hematologic malignancies and is rapidly expanding into other cancers. The global ADC market is booming, projected to surpass $16 billion in 2025 and grow steadily through 2035. Innovations in linker technology, payload design, and AI-driven antibody optimization are accelerating breakthroughs and expanding therapeutic possibilities. Our Wilmington facility is designed to meet the growing demand for high-potency manufacturing, ensure supply chain resilience, and support the next wave of ADC launches . Importantly, this site will support both drug substance conjugation and drug product . This is more than a job - it's a chance to be part of the next wave of cancer care . Whether you're an engineer, scientist, operator, or quality expert, your work here will contribute to life-changing therapies for patients around the world. Together, we'll build a facility that not only meets the highest standards of safety and innovation but also fosters a culture of excellence, inclusion, and impact. Join us in Wilmington and help shape the future of cancer treatment-one molecule at a time. We invite you to become a part of our journey as the Manufacturing Associate Director Drug Product . This role offers you the chance to contribute to the site's development and ensure successful GMP manufacturing. In this position the Manufacturing Associate Director will play a pivotal role in ensuring smooth operation of various aspects of manufacturing. In partnership with site MS& T the Manufacturing Associate Director will provide comprehensive manufacturing and technical leadership to the drug substance organization. Bring energy, knowledge, innovation to carry out the following: <ul><li> Lead and engage with the engineering design firm in detailed design on all aspects of the drug product manufacturing. </li></ul><ul><li> Lead and drive the Process Hazard Analyses and Quality Risk Assessments as necessary. </li></ul><ul><li> Active participation in factory acceptance testing (FAT) and site acceptance testing (SAT). </li></ul><ul><li> Execute automation sprints as necessary in the drug product area, </li></ul><ul><li> Support equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ, etc. </li></ul><ul><li> Perform process and facility fit activities to enable engineering and qualification runs of new products . </li></ul><ul><li> Provide Manufacturing and Technical expertise within the manufacturing team, including areas such as sterile supply, formulation, isolators, filling, lyophilization, capping and visual inspection (manual and automated). </li></ul><ul><li> Support technical deliverables within Drug Product to support the successful tech nology transfer . </li></ul><ul><li> Lead Change controls and Quality Docs as appropriate required for new product introduction. </li></ul><ul><li> Ability to solve complex problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop. Brin g ing in appropriate stakeholders when required . </li></ul><ul><li> Conduct all work activities with a strict adherence to the safety and compliance culture on site. </li></ul><ul><li> Support the Authoring of electronic batch records, sampling plans, and standard operating procedures. </li></ul> What skills you will need: To excel in this role, you will need: <ul><li> Bachelor's degree in engineering, science or related discipline. </li></ul><ul><li> Eight or more (8 +) years working in a cGMP biological, vaccine or pharma facility. Preferred candidate will have cGMP experience with biological, vaccine or pharma facility with prior aseptic manufacturing experience. </li></ul><ul><li> Start-up experience in a large-scale commercial drug product facility is highly desirable. </li></ul><ul><li> Experienced in new facility operational readiness, facility, equipment and process design </li></ul><ul><li> Manufacturing and Technical expertise within the manufacturing team, including areas such as sterile supply, formulation, isolators, filling, lyophilization, capping and visual inspection (manual and automated). </li></ul><ul><li> Demonstrated a bility to lead and operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches. </li></ul><ul><li> Previous experience of manufacturing and technical support of placebo runs, developmental batches and PPQ runs. </li></ul><ul><li> Experience with AVI/MVI and creation of library of defects. </li></ul><ul><li> Previous experience with CQV activities will be advantageous . </li></ul><ul><li> Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e. g., Six Sigma. </li></ul><ul><li> Experience in a risk-based approach to manufacturing through use of tools such as FMEA. </li></ul><ul><li> Ability to adapt to changing priorities as project demands change. </li></ul><ul><li> Understanding of USP1790 and industry / regulatory requirements such as Annex 1. </li></ul><ul><li> Demonstrated skills in planning, communication (oral and written ) and technical writing. </li></ul>Required Skills: Adaptability, Adaptability, Antibody Drug Conjugates (ADC), Aseptic Processing, Communication, Cross-Cultural Awareness, Customer-Focused, Driving Continuous Improvement, Engineering Design, Freeze Drying, GMP Compliance, Leadership, Lean Six Sigma Process Improvement, Management Process, Manufacturing Quality Control, New Product Introduction Process, Organizational Compliance, Pharmaceutical Manufacturing, Pharmaceutical Microbiology, Process Improvements, Production Management, Quality Management, Quality Risk Assessment, Regulatory Compliance, Right First Time (RFT) {+ 5 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $126,500.00 - $199,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: Yes Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 11/29/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R372002

Associate Director, Drug Product Operations - Wilmington Biotech

Job Description The Rahway based Senior Specialist, Global Development Quality Operations, is responsible for independent approval of documentation to support GMP clinical supply drug product manufacture, testing, release, and maintenance in support of our company's clinical supply programs. This person will also independently approve documentation accompanying the disposition of excipients, components, and critical supply items to ensure conformance to appropriate regulatory and company requirements. In support of clinical supply manufacture and/or regulatory inspections independently perform or coordinate routine and specialized audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and our company's requirements. Issue reports summarizing results and work with area to ensure resolution of audit findings. Notifies relevant management of unresolved issues/trends. Specific and/or additional duties may include, but are not restricted to:<ul><li>Advise supported areas on requirements for all assigned project responsibilities as related to quality and our company's standards and communicate project status to management.</li><li>Act as Development Quality representative for in-house or outsourced manufacturing for clinical supplies. Duties include compliance oversite of program-related activities, batch record review and approval, deviation and/or out-of-specification approval, etc.</li><li>Identify need for and/or develop SOPs to ensure practices are accurately reflected. Assist support areas in SOP and quality-related system development and approval.</li><li>Represent Development Quality on inter-departmental and cross-functional teams, ensuring communication of information and providing quality guidance and/or deliverables.</li><li>Independently prioritize work in support of multiple projects including clinical supply disposition commitments and maintenance of a cGMP posture within Global Development Quality.</li><li>Support preparations for regulatory agency inspections. May accompany regulatory agency officials, conducting inspections of facilities or operations in supported areas, including GMP Certification inspection.</li></ul> Education Minimum Requirement: <ul><li>B.S. in appropriate Science or Engineering discipline (chemistry, biology, biochemistry, microbiology); advanced degree preferred. </li></ul> Required Experience and Skills: <ul><li>Minimum 5 years of experience in Pharmaceutical or related industry</li><li>Experience in one or more functional areas such as quality control, quality assurance, analytical laboratories, manufacturing, production support area, clinical development. </li><li>Strong leadership skills with the ability to lead teams of a cross-functional and multi-level nature, including senior management representatives.</li><li>Excellent verbal and written communication including presentation skills.</li><li>GMP or related drug regulation knowledge and expertise.</li><li>Ability to independently manage multiple priorities and projects.</li></ul> Preferred Experience and Skills: <ul><li>Experience in non-sterile and/or sterile drug product manufacture/testing.</li><li>Experience in excipient/component release requirements/testing.</li><li>Experience with manufacturing investigations and CAPA's.</li><li>Familiarity with R&D or clinical supply areas and processes.</li><li>Knowledge and competency in SAP.</li><li>Experience with regulatory or QP inspections.</li><li>Superior skills in collaboration, teamwork, and conflict management.</li><li>Strong analytical problem-solving skills.</li></ul>Notice:<ul><li>The position will initially be assigned to 1st shift (e.g., 7:00 AM-3:00 PM) through the end of 2025 and into 2026. The position is expected to transition to 2nd shift (e.g., 3:00 PM-11:00 PM) in 2026. Applicants should be willing and able to accept a schedule change at that time and thereafter, to work either shift. Reasonable notice of schedule changes will be provided.</li></ul>Requirement:<ul><li>Must be able to work on first and second shift. </li></ul>Required Skills: Accountability, Accountability, Adaptability, Audits Compliance, Biochemistry, Chemistry, Clinical Development, Communication, Data Analysis, Detail-Oriented, Deviation Management, Employee Training Programs, GMP Auditing, GMP Compliance, Good Manufacturing Practices (GMP), Immunochemistry, Interpersonal Relationships, Manufacturing Processes, Manufacturing Quality Control, Microbiology, Molecular Microbiology, Physiology, Process Improvements, Quality Assurance (QA), Quality Assurance Systems {+ 4 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $104,200.00 - $163,900.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day, 2nd - Evening Valid Driving License: No Hazardous Material(s): No Job Posting End Date: 11/22/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R374064

Senior Specialist, Quality Assurance - Non-Sterile Product Quality Operations

Job Description Elkton GES Associate Director, Project Engineering Our company's Global Engineering Solutions (GES) is seeking an initiative-taking Associate Director of Project Engineering to manage capital projects supporting our human health pharmaceutical manufacturing portfolio. The Associate Director will lead a wide range of projects and collaborate closely with Site Leadership, contractors, Safety, Design, Quality, and Maintenance teams. This on-site role is based in Elkton, Virginia, and offers a unique opportunity to contribute to one of the most significant investments in our company's human health manufacturing infrastructure in the United States. You will work alongside top-tier engineering, construction, and operational teams to deliver world-class capabilities. About the Project Our company is launching a major capital expansion at its Elkton, Virginia, site, a Center of Excellence for Pharmaceutical Manufacturing. This $3 billion investment will add approximately 400,000 square feet of state-of-the-art facilities, spanning both Active Pharmaceutical Ingredient (API) and Drug Product capabilities to support small molecule manufacturing and testing. This expansion advances our mission to deliver innovative treatment options for people facing serious health challenges in the U.S. and around the world. Primary Responsibilities include, but are not limited to:<ul><li>Lead capital projects: Plan, direct, and organize resources for capital budgeting, engineering design, procurement, construction management, startup, and commissioning of new or enhanced facilities and utilities.</li><li>EHS leadership: Champion a strong safety culture; ensure projects meet or exceed company EHS targets. Process and Construction Safety.</li><li>Compliance and Quality: Ensure adherence to company Standards and Procedures, and the Quality Manual; Oversee effective QA/QC programs.</li><li>Drive team success: Manage integrated project teams to deliver critical assets on time and within budget; foster collaboration with our company's Leadership, Site Stakeholders, Partners, and cross-functional teams.</li><li>Innovate and Deliver: Develop robust execution and design strategies that address scope, complexity, geography, risk, and business impact; apply Lean Project Delivery and Target Value Delivery to align scope, cost, and value.</li><li>Governance: Lead Capital Governance; run safety and staff meetings; ensure scope control and alignment to business goals; lead funding reviews and stakeholder alignment.</li><li>Risk management: Maintain portfolio risk registers; drive mitigations; integrate compliance, permitting, and logistics risks; guide teams to simple, robust solutions.</li><li>Change management: Enforce governance for scope, cost, and schedule changes; manage approvals and communication throughout the project lifecycle.</li><li>Communication: Manage communications and reporting to keep stakeholders informed and aligned; communicate effectively at all levels.</li><li>People leadership: Manage and coach team members; set clear business priorities and behavior expectations. </li><li>Industry breadth: Apply broad biopharma experience: drug substance, drug product, large and small molecule, utilities.</li><li>Travel: Candidate must live within or relocate to Elkton, VA vicinity. Initial assignment will involve less than 10% travel. Long term must have ability to travel up to 50% of time.</li></ul>Education Minimum Requirement:<ul><li>Bachelor's degree in engineering</li></ul>Required Qualifications and Experience<ul><li>Minimum of eight (8) years of project management experience, overseeing diverse capital projects from design through to construction, commissioning, and close out.</li><li>Exceptional verbal and written communication skills; ability to present project status and funding clearly and effectively.</li><li>Understanding of cGMP and regulatory qualification requirements.</li><li>Proven ability to navigate complex challenges, manage change, and drive project success under tight deadlines.</li><li>Ability to thrive in a collaborative environment that prioritizes business needs.</li></ul>Preferred Qualifications<ul><li>Experience with Lean Project Delivery methodologies such as Target Value Design and pull planning.</li><li>Pharmaceutical manufacturing experience (drug substance, drug product, labs, large and small molecule, utilities.</li><li>PMP or equivalent project management certification.</li></ul>Required Skills: Accountability, Accountability, Adaptability, Automation Systems, Business Communications, Capital Budgeting, Capital Project Analysis, Capital Project Development, Capital Project Management, Capital Project Planning, Capital Projects, Change Management, Clinical Manufacturing, Collaborative Development, Communication Management, Data Analysis, Decision Making, Drug Product Manufacturing, Innovation, Interpersonal Relationships, Leadership, Lean Manufacturing, Manufacturing Scale-Up, Pharmaceutical Manufacturing, Pharmaceutical Systems {+ 8 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $139,600.00 - $219,700.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 11/22/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R374088

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