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Site Name: USA - Pennsylvania - King of Prussia Posted Date: Jul 7 2025 Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals? If so, this Senior Production Specialist opening could be an exciting opportunity to explore! The Senior Production Specialist will be part of a high performing team responsible for delivering the supply of GSK products to the One Biopharm supply chain. They will demonstrate GSK Values (Patient Focus, Transparency, Respect, & Integrity) and Expectations (Courage, Accountability, Development, & Teamwork) on a daily basis by engaging positively with team members and production support groups. The Senior Production Specialist can be expected to lead pieces of work associated with supporting new product introduction (via the Tech Transfer Process) and/or improvement of existing processes. The work this role will support will follow the lifecycle of new and existing products, more specifically: Technology Transfer, Commissioning & Qualification, Engineering/Clinical Batch manufacture, Process Performance Qualification batch manufacture, Commercial batch manufacture, Changeover, and Process/System Improvements. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... <ul><li>Demonstrate GSK Values - Our culture of Ambitious for patients, Accountable for Impact and Do the right thing are the foundations for how, together, we'll deliver for our patients, shareholders and GSK people.</li><li>Engage in cross functional teams, using operational knowledge, project management skills, and leadership ability to gain alignment on proposals to prioritize improvements that simplify both technical (equipment, biopharm processes) and business systems (quality systems, logistics, etc). As a leader, ensures the team has appropriately prioritized these initiatives and is developing the capabilities to execute them.</li><li>Understand production equipment and electronic systems in use (SAP, DeltaV, MES, IP21, etc) and P&ID diagrams of production equipment, as well as site quality processes (deviation, CAPA, change control). Serve as technical experts for the production process and owners of production equipment, reviewers of automation/validation documentation, and support the coaching and development of operators and manufacturing specialists in these processes.</li><li>Own interactions between the production team and other departments, understanding impact of their needs versus the production schedule. Balance the team's ability to lead day to day operations with the consistent project management of programs and systems that need improvement over the long term.</li><li>Adhere to safety procedures and training requirements in accordance with site, GSK, and federal regulations including the proper use of controls, personal protection equipment, and waste handling practices. Escalate equipment and processing issues that pose a safety or compliance risk.</li><li>Follow ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) principles for all documentation of performed tasks. Own deviation investigations, write-ups, and management of corrective and preventative actions, impact assessments, and change controls (AL1, AL2). Interact with agency (FDA, EMEA, etc.) auditors when required. Can present the aforementioned quality documents in a regulatory inspection, and can support the sustainability of their quality over the long term.</li><li>Schedule and track activities which (directly or indirectly) impact the schedule of manufacturing and/or required documentation. Manage inventory of raw materials and single-use components, execute Batch Document revisions, and perform the role of Lead Investigator via the deviation management process.</li><li>Identify and implement processing improvements in operations, improvement to quality systems and ways of working, and required documentation updates within the controlled systems of the site. </li><li>In support of technology transfer (TT), responsible for the authoring and/or review of key TT deliverables (e.g. batch documents, Process Transfer Documents (PTDs), Media/Buffer Trace Matrices, ERP Data Maintenance/Setup, Sampling Plans).</li><li>Maintain accountability for deliverables adherence to Integrated Project Plan (IPP) in support of campaign certification. Engage within the TT Sub-team by providing input for decisions as well as present and lead discussions on relevant topics. Expectation is that during manufacturing campaigns, this role could spend up to 60% of time in the production suite supporting operations to ensure right first time (RFT) execution and gather feedback and understanding for potential process improvements/optimizations.</li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li> Bachelors Degree. </li><li> 5+ years of GMP processing and/or industry related experience, exhibiting a skillset of supporting all aspects of production processing and demonstrating technical competency. </li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li> Bachelor's degree in Engineering or Biotechnology. </li><li> Prior biopharmaceutical manufacturing experience . </li><li> Excellent communication skills and ability to influence. </li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

public

Senior Production Specialist

Site Name: USA - New York - Syracuse Posted Date: Jul 7 2025 ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV Healthcare is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and affected by HIV. Our aim is to think, act, and connect differently through a focus on education on for the prevention and treatment for HIV. We go to extraordinary lengths to deliver the sorts of breakthroughs, both in prevention, treatments, care solutions and communities, that really count. We go beyond the boundaries of medicine by taking a holistic approach to HIV through developing and supporting sustainable community programs and improving access to care. We are fully committed to push through every challenge until HIV/AIDS is eradicated. ViiV Healthcare has played a significant part in delivering breakthroughs that have turned HIV into a manageable health condition. We offer the largest portfolio of HIV medicines available anywhere, and we continue our work to cater for the widest possible range of needs in response to the HIV epidemic. We are aware of how much is at stake for those at-risk or affected by HIV and we show up every day 100% committed to the patients. Our work culture is fast-paced, diverse, inclusive, competitive, and caring. But ViiV Healthcare isn't just somewhere to work - it's a place to belong, an invitation to bring your very best, and a team full of impact-driven team members who are hungry to make a difference. While we have been improving lives of HIV patients for 30 years, this is an especially exciting time to be at ViiV Healthcare, as we evaluate novel approaches to treatment and prevention that could further reduce the impact of HIV on individuals and communities. ViiV Healthcare is seeking an experienced, results-driven professional in Specialty Sales for the position of Territory Account Manager (TAM) on the long-acting HIV Prevention Sales team. The ability to thrive in a fast-paced, complex environment and work with HCPs to adopt a new approach to HIV prevention will be essential to delivering success in this role. Additionally, the abilities to partner cross-functionally and to remain highly adaptable in a launch context will be critical. It is expected that the successful candidate will have demonstrated experience in developing strategic business plans with specific, measurable, action-oriented objectives in accordance with territory and account level goals. Successful outcomes will include selling to HCPs, servicing their accounts, and being aligned to ViiV Healthcare's mission of leaving no person with HIV behind. This will be achieved through driving results against business objectives and working effectively within an integrated account management framework in the setup and delivery of a buy and bill treatment model. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: <ul><li> Deliver Results Through Exceptional Sales and Service </li><li>Identify, target, and win new business by influencing working with HCPs to adopt a new approach to HIV treatment</li><li>Engage with HCPs, nurses, staff, and administrators to accurately understand the clinical, organizational, and financial challenges and opportunities within target accounts</li><li>Leverage data analytics, business acumen, and market expertise to identify high-priority prospects</li><li>Prepare and execute business plans that are tailored to the unique needs of each customer and that help HCPs scale their treatment model to reach more patients</li><li>Coordinate, engage, and partner with multiple cross-functional team members (i.e., Clinical Nurse Educators and Field Reimbursement Managers) to deliver an integrated product experience to customers</li><li>Maintain a portfolio-based selling mindset and close internal communication loops to ensure customers experience a cohesive, integrated ViiV</li><li>Provide exceptional customer service by proactively anticipating and addressing HCP problems, needs and requests</li><li>Deliver and adapt execution plans to achieve performance goals and objectives utilizing; KPIs, scaling of successes, business problem solving, etc.</li><li>Develop and foster external relationships with key influential customers and thought leaders</li><li> Compliance, Accountabilities, and Values Based Culture </li><li>Act in ways consistent with ViiV's culture, expectations, and values</li><li>Be an agent of change by embracing the ambiguity in a launch environment and seeing setbacks as opportunities to learn and grow</li><li>Escalate issues and risks when needed; display courage by 'speaking up'</li><li>Understand and follow key compliance and regulatory guidelines</li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li> BA/BS degree </li><li> 5+ years of pharmaceutical sales experience </li><li> 3 plus years' specialty experience </li><li> Ability to travel domestically as necessary, which may include overnight travel, majority of time will be spent in market </li><li> Valid Driver's License </li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>Degree in Business, Marketing, or Life Sciences</li><li>Strong planning and organization skills, analytical ability, business acumen, decision making ability, and problem-solving skills</li><li>Experience to influence and collaborate cross-functionally in a matrixed environment</li><li>Excellent written and oral communication skills</li><li> Experience in sales success in complex market access coverage situations </li><li>Experience working with HCPs to procure, manage, and administer cold chain treatment products</li><li>Knowledge of the HIV treatment and/or prevention markets</li><li>Bilingual in Spanish, preferred but not required</li><li> Experience partnering cross functionally within an integrated account team model that includes multiple field-based team members </li></ul>The annual base salary for new hires in this position ranges from $139,500 to $232,500 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program ViiV offers US employees. All ViiV employees receive the same benefits options and plans as GSK employee. Why Us? At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 39 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV. We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently. Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, we are determined to help end the HIV epidemic. We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe. We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care. As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK. Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do - from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities. Having a truly inclusive culture where we're all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to leave no person living with HIV behind. If you require an accommodation or other assistance to apply for a job at ViiV, please contact the ViiV Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). ViiV is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies ViiV does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact ViiV's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ViiV. ViiV shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, ViiV may be required to capture and report expenses ViiV incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure ViiV's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Territory Account Manager - Syracuse / Upstate NY

Site Name: USA - North Carolina - Zebulon Posted Date: Jul 7 2025 Are you looking for a high-profile supply chain leadership role that allows you to accelerate efficiency and global product delivery? If so, this Cross Border Technical Lead role could be an ideal opportunity to explore. As a Cross Border Technical Lead, you will play a key role in the Global Supply Planning Hub by contributing to everything related to attaining the right level of inventory of finished products, Active Pharmaceutical Ingredients (API) and Bulk in the network. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Position Overview: We are seeking a highly skilled Cross Border Technical Lead to lead, optimise and manage the smooth flow of MDS-CSC materials across country borders, spearheading the enhancement and integration of cross-border operations. This strategic role is pivotal in enhancing our operational effectiveness as well as advancing our use of technology capabilities. The successful candidate will collaborate with international stakeholders, and ensure seamless technical implementations across different regions and different aspects of the MDS -CSC business (Medicines, Vaccines, Third Party Manufacture etc.) Key Responsibilities:<ul><li>Design and develop Cross Border Compliance processes that CSC will use for the Clinical Trial Portfolio that assure compliance of cross border movements. Lead and coordinate the integration of cross-border technical projects from conception to execution, ensuring alignment with business objectives, on time and within budget.</li><li>Deliver compliance with local and international regulations, standards, and best practices (in conjunction with Global Trade Compliance group, Corporate (Indirect) Tax group, and other key stakeholders (such as R&D Finance and R&D Legal). Designing /utilizing clear methodologies to translate the Cross Border rules into R&D operational procedures eg SOP's, guidelines etc.</li><li>Develop and maintain strong relationships with international vendors, partners, stakeholders and GSK's expert LSPs to assist in execution of duty management programmes.</li><li>Conduct a thorough analysis of cross-border challenges and opportunities, providing actionable insights and innovative solutions. Support Cross Border execution activities as required.</li><li>Within the Cross Border team, identify any areas that require process improvements with CSC Cross Border. Establish an appropriate risk-based MM programmes, supporting the completion of Audit and Self-Inspection Programmes within and across MDS-CSC. Provide expertise for auditing purposes for R&D. Define KPI's, Objectives and metrics (leading and trailing). Continuously monitor and evaluate project and business performance, implementing improvements as needed. Regularly report to senior management and relevant stakeholders on CSC /PLDC's performance, including compliance status and any breaches or issues that arise.</li><li>Present technical findings and recommendations to senior management and stakeholders in a clear, persuasive manner.</li><li>Act as the Single Point Accountable Person for Distribution Crisis management within PLDC, as well as providing support for ad hoc challenges from countries with respect to local interpretation of requirements, in conjunction with GSK's End to End Supply Chain Subject Matter Experts.</li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>At least 2 years of experience in leading technical / strategic projects and or large matrix change initiative requiring delivery through others.</li><li>Experience working in a complex regulatory environment (high learning agility) and assess gaps with clear ability to prioritize and know what's the most important</li><li>Demonstrated experience with understanding international regulatory environments and compliance issues, with the ability to demonstrate experience of deploying both successfully.</li><li>Experience in software integration and architecture.</li><li>Experience in technical applications such as; Word, Excel, PowerPoint, Power BI, Power Apps, Teams, Visio, data visualizations and Microsoft Project.</li><li>Ability to travel internationally as required.</li><li>2 years of experience with leadership skills and a strong track record of successfully managing delivery via Matrix leadership.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>Up-to-date and in-depth knowledge of R&D clinical supply chains, timelines, challenges and ways of working</li><li>Excellent communication and interpersonal skills, capable of working effectively in multicultural environments and across a wide range of seniority levels.</li><li> Previous experience in Cross Border Logistics and or Customs ways of working is advantageous, but not essential. </li></ul>#GSK-LI Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Cross Border Compliance Portfolio Manager

Site Name: Field Worker - USA Posted Date: Jul 7 2025 ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV is highly mission-driven in our unrelenting commitment to be a trusted partner for all people living with and affected by HIV. Our aim is to think, act, and connect differently through a focus on education on and treatment for HIV. We go to extraordinary lengths to deliver the sorts of breakthroughs, both in treatments, care solutions and communities, that really count. We go beyond the boundaries of medicine by taking a holistic approach to HIV through developing and supporting sustainable community programs and improving access to care. We are fully committed to push through every challenge until HIV/AIDS is eradicated. ViiV has played a significant part in delivering breakthroughs that have turned HIV into a manageable health condition. We offer the largest portfolio of HIV medicines available anywhere, and we continue our work to cater for the widest possible range of needs in response to the HIV epidemic. We are aware of how much is at stake for those affected by HIV and we show up every day 100% committed to the patients. Our work culture is fast-paced, diverse, inclusive, competitive, and caring. But ViiV isn't just somewhere to work - it's a place to belong, an invitation to bring your very best, and a team full of impact-driven team members who are hungry to make a difference. While we have been improving lives of HIV patients for 30 years, this is an especially exciting time to be at ViiV, as we evaluate novel approaches to treatment and prevention that could further reduce the impact of HIV on individuals and communities. ViiV is seeking a candidate to fill the role of Market Development Director . This role will be joining the Long Acting Injectable (LAI) HIV Treatment Sales Team, reporting into the Field Strategy and Operations Head and working in close partnership with the Sales VP, Area Vice Presidents, Marketing Brand Lead, and the Market Development team across ViiV brands. The main goal of this role is to increase sales performance with a focus on key regions, territories, and customers. This is a critical role that connects the field needs, the competitive landscape, and our internal resources so we can support the sales organization with the right cross functional approach. The Market Development Director is expected to maximize our sales operations teams (including systems, process, insights, and analytics) support to create acceleration in sales performance. Additionally, this role interacts with Brand Marketing, Medical, Digital Marketing, Access and Payer teams and requires understanding the wider strategic picture while going deep into execution at territory level. This role will also be responsible for collaborating with the Market Development team across the portfolio to share insights, best practices, and lead collaboration efforts towards a One ViiV team approach across brands. The role co-creates strategies with first line sales leaders (Regional Sales Directors) and second line sales leaders (Area VPs) while leading without authority and gaining trust to effectively support the performance agenda. This role gives YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: <ul><li>Integrate field knowledge with multiple data sources across Insights and Analytics and Marketing and sub-national trends to transform and execute the business at higher levels.</li><li>Collaborate closely with the LAI treatment sales leadership team, understanding their needs and providing guidance when needed.</li><li>Partner closely with the extended Sales Operations group to act as one team across the portfolio, including maximizing current analytics, systems and reports and incentive compensation strategies to identify and monitor growth opportunities.</li><li>Influence the broader organization to align to the Field Strategy and Operations go to market deployment strategies to maximize execution and usher in business transformations.</li><li>Propose a national plan to prioritize key regions, territories, customers to achieve performance excellence.</li><li>Build trust with First Line Sales Leaders and Second Line Sales Leaders to Co-create business plans and connect the dots across the organization while influencing support from home office teams.</li><li>Proactively seek and maintain in depth knowledge of the industry, managed healthcare trends and the local marketplace and customer insights including, but not limited to, integrated healthcare delivery systems, physician organizations, HIV/AIDs organizations (ASO, CBO etc.), major employers and pharmacy networks. </li><li>Ensure pull through of national sales, marketing and payer and access opportunities.</li><li>Support the training team agenda and ensures consistency of messaging across the nation.</li><li>Understand, interact and influence marketing, digital marketing, and payer strategies.</li><li>Identify with clarity the size and ROI of opportunities to align with financial and sales goals.</li><li>Maintain a deep understanding of customer insights and regional account environment including the specific HIV community and ecosystem and then collaborate with the appropriate ViiV commercial stakeholders to maximize opportunities.</li><li>Analyze area/regional business trends based on market dynamics. </li><li>Ability to flexibly respond and make necessary adjustments to environment changes; such as generic intrusion, Managed Care formulary changes, State Medicaid, non-retail business and unique product opportunities key.</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Bachelor's Degree & 10 plus years of pharma experience to include 2 of the 4: Sales OR Marketing OR Operations OR Analytics</li><li>2 plus years of Leadership Experience</li><li>Product Launch Experience</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>Demonstrated strong analytical profile of creating insights and influencing decision making.</li><li>Highly proactive to bring a new perspective, challenge status quo and move the organization in the right direction.</li><li>Demonstrated emotional intelligence and focus in GSK values: Teamwork, Accountability, Development and courage.</li><li>Demonstrated capabilities to manage complex matrix organizations.</li><li>Ability to synthesize and communicate messages to different audiences.</li><li>Specific experience with injectables, HIV, and/or PrEP</li><li>Experience understanding HIV community and ecosystem.</li><li>Candidates with Consulting background.</li><li>Breadth of experience is highly valued.</li><li>First Line Sales Leader experience.</li></ul>#LI-Remote #LI-GSK #LI-ViiV Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program ViiV offers US employees. All ViiV employees receive the same benefits options and plans as GSK employee. Why Us? At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 39 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV. We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently. Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, we are determined to help end the HIV epidemic. We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe. We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care. As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK. Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do - from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities. Having a truly inclusive culture where we're all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to leave no person living with HIV behind. If you require an accommodation or other assistance to apply for a job at ViiV, please contact the ViiV Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). ViiV is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies ViiV does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact ViiV's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ViiV. ViiV shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, ViiV may be required to capture and report expenses ViiV incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure ViiV's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

ViiV Market Development Director - Field Worker

Site Name: USA - Michigan - Lansing, USA - Michigan - Flint, USA - Michigan - Kalamazoo Posted Date: Jul 7 2025 Territory to include but not limited to Lansing, Michigan, Flint Michigan, Jackson, Michigan, Kalamazoo, Michigan and Saint Joseph, Michigan Why join us? GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the of decade, as a successful, growing company where people can thrive. We are a focused biopharma company. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and advanced technologies, investing in four core therapeutic areas (Infectious Diseases, HIV, Respiratory, Immunology and Oncology). Our Ahead Together strategy means intervening early to prevent and change the course of disease, helping to protect people and support healthcare systems. It's an exciting time in GSK as we bring outstanding people together to do work that matters and impacts the worlds health. The GSK respiratory business is one of the largest in the world, with over 50 years of investment and innovation in respiratory research for both Asthma and COPD, expanding the portfolio to meet the needs of patients. The Specialty Sales team is responsible for selling one of the respiratory portfolio cornerstones of growth now and in the future. What we're looking for: This role will provide you the opportunity to lead key activities, career growth, and the ability to do impactful work: Responsibilities include the following: Key Responsibilities: Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role<ul><li>Provide Scientific Knowledge, Business Acumen, and Customer Engagement expertise to specialist customers in support of a GSK biologic product. </li><li>To understand the reimbursement/distribution landscape for specialist customers and identify the appropriate resources (e. g. Payer Relations Managers, HUB, headquarter approved materials) to refer customers to appropriate resource for reimbursement and distribution choices, always working within GSK guidelines and values. </li><li>Maintain knowledge and data, which are constantly changing, with respect to severe asthma therapeutic expertise. </li><li>Provide product educational programs/in-services to customers.</li><li>Work within Compliance guidelines and GSK values always. </li><li>Develop strategies and tactics to generate sales.</li><li>Develop and implement strategies specific to each customer within an account (i.e., Allergists, Pulmonologists, nurses, PAs, business/office managers). </li><li>Develop and maintain strong working relationships with Marketing, Payer Relations Managers (Market Access), Medical (MSLs), and other functions within GSK. </li><li>Effectively manage allocated resources (i.e., financial).</li><li>Provide outstanding customer service by responding to our customers' requests, inquiries and needs.</li></ul>Why You? Basic Qualifications:<ul><li>Bachelor's degree </li><li>Ability to travel domestically as necessary, which in some territories may include overnight travel up to 30% </li><li>Valid driver's license. </li><li>Must be able and willing to drive or operate a vehicle - driving is an essential function of this role.</li><li>The selected candidate will be hired at the appropriate level based on experience<ul><li>Specialty Account Specialist (grade 8): 5+ years of pharmaceutical/medical device experience.</li><li>Senior Specialty Account Specialist (grade 7): 12+ years of pharmaceutical/medical device experience.</li></ul></li></ul>Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>Specialty Products that utilize the Buy & Bill or Specialty pharmacy modes of distribution. </li><li>Expertise in working with Payer Reimbursement Managers</li><li>Biologic/Rare Disease/Respiratory Sales experience </li></ul>Ready to get Ahead of Disease TOGETHER? Apply now! We want GSK to be a diverse, inclusive organization that attracts and retains outstanding talent, because this brings greater opportunity to create better health outcomes for the patients around the world who rely on our medicines and vaccines. #LI-GSK #LI-Remote Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Sr Acct Spec, USC Specialty Respiratory - Lansing, Michigan

Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, USA - California - San Francisco, USA - Massachusetts - Cambridge Posted Date: Jul 7 2025 As Principal Scientist, in the Protein Design and Informatics (PDI) team, you will focus on developing, integrating, and embedding bleeding edge computational methods and predictive in silico models that drive the discovery of new medicines and vaccines. Included in the larger Data, Automation, and Predictive Sciences (DAPS) department, we have an exciting initiative aimed at researching and implementing new methods for the automation of the entire Design-Make-Test-Analyze cycle, impacting target discovery to the clinic - all stages of a therapeutic project. You'll have the opportunity to work in close partnership with many departments across GSK, developing and fostering a high-performing team culture of collaboration, curiosity, consistency, agility, quality, peer review, and continuousimprovement with a relentless focus on creating medicines for patients. We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK In this role you will <ul><li>Work to generate, validate, and integrate multimodal generative AIML models for the de novo design and multi-objective optimization of tool and therapeutic biologics, such as antibodies, antigens, peptides, ADCs, and oligonucleotides.</li><li>Build and exploit agent-orchestrated, integrated Design-Make-Test cycles with automated experimental platforms generating quality data at scale needed for project-specific and foundational models.</li><li>Innovate, develop, and apply predictive models for protein design and developability engineering, utilizing large-scale NGS, patient-derived, and other proprietary in-house and external data sources.</li><li>Identify and advocate for the opportunities afforded by scientific computation and platform automation and champion a predict-first" culture by maximizing use of predictive technology in therapeutic project plans.</li><li>Collaborate with external groups to further develop protein engineering computational methods.</li></ul>Why you? Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals:<ul><li>PhD or equivalent in Bioinformatics, Physics, Chemistry, Computer Science, Structural Biology, or related fields.</li><li>Experience in protein structural or sequence analysis</li><li>Experience in one or more programming languages (e.g. Python)</li><li>Prior experience working as team lead or member in a matrix environment</li><li>Have experience working across scientific and technical disciplines to deliver impactful solutions that drive project progression</li></ul>Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus <ul><li>Experience developing or applying modern ML architectures for protein design models (LLMs, diffusion models, flow-matching, Bayesian Optimization, GNNs, etc.)</li><li>Experience designing de novo binders for specified targets and epitopes</li><li>Experience with cloud engineering production-ready robust and scalable scientific workflows</li><li>Experience building and deploying agentic workflows</li><li>Experience analyzing NGS-derived antibody repertoires for sequence- and structure-based design</li><li>Experience predicting structures of RNA or nucleic acid-protein complexes</li><li>Experience with molecular simulation and conformational analysis techniques</li><li>Demonstrated learning agility, and scientific curiosity while maintaining focus on driving greater impact in the face of uncertainty and change</li><li>Ability to generate conclusion reports, present data in team meetings and participate in writing of abstracts and publications for the scientific community</li></ul>#LI-GSK The annual base salary for new hires in this position ranges from $121,275 to $202,125 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Principal Scientist, Protein Design and Informatics

Site Name: USA - Washington - Seattle, USA - Washington - Spokane Posted Date: Jul 7 2025 Territory will cover Washington State. The ideal candidate will reside in Seattle Metro area or Spokane, Must live near a major airport. Relocation assistance not provided. At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. Our R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology, and disease mechanisms, transforming medical discovery. We're revolutionizing the way we do R&D by uniting science, technology, and talent to get ahead of disease together. The Vaccine Key Account Lead (VKAL) plays a crucial role in engaging C/D level clinical and non-clinical stakeholders within large health systems to understand their unique needs and priorities, delivering a customized value proposition. As a VKAL, you will leverage your strong customer relationship and engagement skills, knowledge of healthcare contracting, and account management expertise to drive successful outcomes. Your role will involve consultative selling, product knowledge, contract management, and ensuring sales and ethical compliance. You will also need to be adept at digital literacy, data analytics, and omnichannel engagement. Key Responsibilities:<ul><li>Engage with C/D level stakeholders within large health systems to understand their unique needs and priorities.</li><li>Deliver a customized value proposition that aligns with customer needs and GSK's vaccines portfolio.</li><li>Develop and execute strategic account plans to drive vaccines sales and market penetration within designated territories.</li><li>Establish and maintain strong relationships with healthcare professionals, healthcare delivery networks, and other key stakeholders.</li><li>Collaborate with internal teams, including marketing, R&D, and business development, to align on strategies and ensure seamless execution.</li><li>Conduct thorough market analysis to identify opportunities and threats and adjust strategies accordingly.</li><li>Provide expert knowledge on GSK's vaccines portfolio, competitive products, and industry trends to inform and influence stakeholders.</li><li>Present and communicate effectively with stakeholders at all levels, including live and remote presentations.</li><li>Negotiate and manage contracts with healthcare systems to secure favorable terms and conditions for GSK's vaccines.</li><li>Monitor and report on sales performance metrics, providing insights and recommendations for continuous improvement.</li><li>Travel up to 40% to meet with key accounts and attend relevant industry events.</li></ul>Why You? Basic Qualifications:<ul><li>Bachelor's Degree</li><li>Must possess a combined minimum of 5 years of the following: Vaccines or Pharmaceutical Sales, Pharmaceutical Marketing, Payer, Business Development, and/or large account/hospital account management experience.</li><li>Valid driver's license</li><li>Ability to travel up to 40% based on specific geography size</li></ul>Preferred Qualifications:<ul><li>Experience calling on awardees (DOH)</li><li>Master's degree in business, public health, hospital administration, or a similar field.</li><li>Deep knowledge of contracting in the healthcare industry.</li><li>Vaccines sales experience</li><li>Expertise in the vaccines marketplace, GSK and competitive portfolios, and customers.</li><li>Deep knowledge of the Health Systems business model, organizational structure, key stakeholder roles, and decision-making processes (P&T, formulary, etc.).</li><li>Experience calling on C/D level within large, complex healthcare delivery networks (IDNs and similarly structured systems).</li><li>Experience with lateral leadership in a highly matrixed organization.</li><li>Solid strategic aptitude and advanced business acumen.</li><li>Demonstrated ability to develop and execute local-level business and strategic account plans.</li><li>Strong communication, presentation (live and remote), and influencing skills.</li><li>Demonstrated skills in digital literacy, data analytics, and omnichannel engagement.</li><li>Emotional resilience and a growth mindset.</li></ul>#VaccinesLeadership The annual base salary for new hires in this position ranges from $149,250 to $248,750 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Vaccine Key Account Lead - Washington State

Job Description The Global Scientific Training Associate Director is accountable for these core activities: <ul><li> Creation and delivery of timely, high quality, and contextualized scientific training materials for a global audience to enhance the effectiveness of scientific exchange </li><li> Leveraging technology to enhance scientific training interactivity and engagement </li><li> Assessing qualitative and quantitative data and feedback to continuously improve and inform decisions related to scientific training </li><li> Execution of annual Global Scientific Training plans to support the Value & Implementation plans, which includes ensuring strategic collaboration with regions and countries to assess and incorporate training needs </li></ul> A high degree of collaboration is required within the Center for Scientific Exchange Excellence, as well as critical cross-functional partners including Global Medical & Scientific Affairs TA Strategy teams, the Global Scientific & Value Content Teams, other Global Medical Value Capabilities functional areas, and Regional Field Medical Leadership. The Global Scientific Training Associate Director must possess subject matter expertise, project and vendor management proficiency, strong communication skills, persuasive skills, and the ability to lead without direct authority over a continuum of stakeholders. Knowledge of our Company's systems (e.g.; Veeva Vault, SharePoint, Microsoft Office, Axonify Discover) is required to manage training materials, approval processes, and training material life cycles. Education Minimum Requirements <ul><li> PharmD / PhD / MD and a minimum of 2 years of relevant experience in pharmaceutical industry or clinical practice -OR- </li><li> Master's Degree in Life Sciences and a minimum of 5 years of relevant experience in pharmaceutical industry or clinical practice -OR- </li><li> Bachelor's Degree in Life Sciences and a minimum of 7 years of relevant experience in pharmaceutical industry or clinical practice </li></ul> Required Experience and Skills <ul><li> Therapeutic competency in general and/or specialty medicine </li><li> Experience in creating and implementing training global programs </li><li> Understanding of adult learning principles and training curriculum design </li><li> Experience working in a complex organizational matrix environment, operating effectively in a team-oriented global structure with extensive cross-functional collaboration </li><li> Excellent interpersonal and communication skills, including scientific writing </li><li> Demonstrated excellence in project management </li><li> Vendor management </li><li> Thorough understanding of the field medical role, publications process, scientific platform development, and global medical communications processes</li><li>Prior experience working within multiple regional regulations and compliance requirements</li><li>Strong analytical skills and ability to translate strategy into action plans</li><li>Advanced proficiency in Microsoft Office</li></ul> Preferred Experience and Skills <ul><li>Advanced Degree Medical Doctor/Pharmaceutical Doctorate, or Doctorate in Philosophy/Nursing</li><li>Medical Affairs experience.</li><li>Therapeutic competency in oncology</li><li>Relevant working experience in Medical Affairs in the pharmaceutical industry</li></ul>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: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Remote Shift: Valid Driving License: Hazardous Material(s): Required Skills: ABPI Code of Practice, ABPI Code of Practice, Adaptability, Business, Business Management, Clinical Medicine, Clinical Research, Good Clinical Practice (GCP), Innovation, Investigator-Initiated Studies (IIS), Management Process, Medical Affairs, Medical Communications, Medical Knowledge, Medical Marketing Strategy, Oncology, Ophthalmology, Pharmaceutical Management, Pharmaceutical Medical Affairs, Professional Networking, Project Procurement Management, Regulatory Compliance, Scientific Exchange, Scientific Writing, Strategic Planning {+ 5 more} Preferred Skills: Job Posting End Date: 07/21/2025 *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:R354267

Associate Director, Global Scientific Training - Oncology (Remote)

Job Description The Quantitative Pharmacology and Pharmacometrics (QP2) department of our company's Research Laboratories in Rahway, NJ is seeking a collaborative Operations Scientist to join our QP2 Operations Team. Responsibilities: The QP2 Operations Scientist will work with QP2 scientists and cr o ss- f uncti o nal partners to advance the pipeline of novel therapeutic agents at our Company. QP2 Operations Scientists will enable tactical, logistical and operational elements of pertinent workflows, including but not limited to those in support of data needed for QP2 modeling, support of filings, and management of regulated document workflows. The Operations Scientist will develop a deep understanding of how to enable QP2 deliverables with a focus on strategically solving tough operational and scientific challenges, streamlining end-to-end process, and improving operational efficiency. More specifically, an Operations Scientist will work with QP2 scientists and key partner functions (such as bioanalytical sciences, data management, statistics/statistical programming, and external vendors) to:<ul><li>Enable smooth functioning and continuous improvement of QP2 involvement in clinical trials, including troubleshooting to resolve clinical study data issues.</li><li>Ensure QP2 data requirements are integrated into evolving clinical data systems.</li><li>Support QP2 needs for clinical trial operations, dataset creation, analyses (including conducting noncompartmental analysis) and reporting.</li><li>Simultaneously manage timelines of multiple clinical studies, QP2 deliverables and document reviews. </li><li>Gain expert level familiarity with regulatory publishing and take primary responsibility for publishing and editorial filing readiness of modeling and simulation reports for filings.</li></ul>The selected candidate will be expected to operate with an enterprise mindset, be comfortable operating in ambiguous situations and with independence. Education Requirement: A MS, PharmD or equivalent degree - OR- a BS or equivalent degree with at least two years of experience, where experience" means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia. Skills: Required: <ul><li>An educational background in quantitative sciences, including but not limited to pharmaceutical sciences, pharmacy, pharmacometrics, mathematics, statistics/ biostatistics, computational biology/chemistry, chemical/biomedical engineering or public health.</li><li>Excellent written/verbal communication and interpersonal skills with a proven ability to collaborate with individuals across multiple different areas of expertise.</li><li>Organization skills, strong attention to detail, an operations-oriented mindset, and a propensity for troubleshooting complex issues.</li><li>Proven ability to work on multiple projects at the same time and manage timelines/deliverables appropriately.</li></ul>Preferred:<ul><li>Background in health or pharmaceutical sciences.</li><li>Demonstrated leadership experience, with an ability to work through ambiguous situations, and a team-oriented enterprise mindset focused on identifying efficiencies and driving innovative solutions.</li><li>Knowledge of or experience with clinical trial conduct, trial operations, clinical databases and data standards (e.g CDISC, SDTM and ADaM).</li><li>Experience implementing noncompartmental analysis (NCA) using PK software (e.g. Phoenix), statistical software (e.g. SAS), or other pharmacometric analyses via NONMEM, Monolix, R, etc.</li><li>Proficiency utilizing Microsoft Office suite, in particular Microsoft Excel.</li></ul>This is a uniq u e oppor t unity to advance your career while learning the fascinating world of pharmaceutical R&D in one of the world's most research-intensive biopharmaceutical companies. Your role at our Company is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our Company, we're inventing for life. 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: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Required Skills: CDISC ADaM, Collaboration, Communication, Cross-Functional Teamwork, Data Analysis, Data Engineering, Data Science, Data Visualization, Pharmaceutical Development, Phoenix WinNonlin, Stakeholder Relationship Management, Study Data Tabulation Model (SDTM) Preferred Skills: Data Modeling, NONMEM, Pharmacometrics, R-Studio Job Posting End Date: 07/14/2025 *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:R355512

Quantitative Pharmacology & Pharmacometrics Operations Specialist

Job Description Our Company's Research Laboratories in South San Francisco is seeking a lab based Senior Scientist with experience in biochemical/biophysical assays and lead discovery support to join our Quantitative Biosciences (Pharmacology) department. The successful candidate will be responsible for the design, execution, and interpretation of binding and functional assays as well as mechanistic experimentation to advance early drug discovery projects across various modalities. The candidate will work closely with a team of multidisciplinary scientists to enable strategies for assay development, screening, and mechanism of action studies to advance a diverse portfolio of therapies for cardiometabolic disorders and oncology. We value transparent communication, creative thinking, teamwork, and rigorous scientific exploration. If you are a highly motivated individual and team player with a strong desire to impact drug discovery across multiple therapeutic areas, we invite you to consider joining our team. Key Responsibilities:<ul><li>Develop and execute radioligand binding assays to characterize biomolecular interactions (equilibrium and kinetic) for lead discovery and optimization</li><li>Support a wide range of biochemical and biophysical assays for screening and mechanistic studies using diverse experimental methodologies</li><li>Ensure high-quality data generation, analysis, and timely report to project teams</li><li>Leverage lab automation to improve assay operation, quality, and overall productivity</li><li>Properly document experimental design, findings, and assay protocols; comply with all laboratory training and safety requirements</li><li>Collaborate with colleagues within Quantitative Biosciences and on multi-disciplinary project teams to provide scientific/technical contributions and deliver on project goals</li><li>Drive scientific and technical innovations to develop and enhance functional capabilities</li></ul>Qualifications: Education:<ul><li>Bachelor's or Master's (with 8+ years) or Ph.D. (with 2+ years) in Biochemistry, Biophysics or a related field with relevant experience in an academic or industry setting</li></ul>Required Experience and Skills:<ul><li>Prior experience developing equilibrium and kinetic radioligand binding assays (e.g. 125I, 3H, 35S, 14C) in relevant formats (purified protein, cells and/or membranes)</li><li>Demonstrated proficiency in a wide range of biochemical and biophysical assay methods and techniques (e.g. enzymatic and thermal shift assays using various detection technologies, SPR and other biosensors, mass spectrometry, etc.)</li><li>Hands-on experience with liquid handling instruments (Apricot, Dragonfly, Bravo, Echo, etc.) for assay operation, as well as automated data processing and visualization software tools</li><li>Strong work ethic and commitment to lab-based experimentation, as well as proven ability to independently design/execute experimental tasks and deliver results under tight timelines</li><li>Excellent verbal, written, and interpersonal communication skills with a track-record of working effectively with diverse stakeholders in a cross-functional matrix team environment</li></ul>Preferred Experience and Skills:<ul><li>Broad knowledge of G-protein coupled receptor (GPCR) pharmacology</li><li>Tissue culture skills including cell plating, harvesting, and membrane preparation</li><li>Protein biochemistry expertise (gene cloning, transfection, expression & purification)</li><li>Prior experience as functional area representative in matrixed drug discovery project teams</li><li>Prior experience with multiple therapeutic modalities (small molecule, peptide, antibody, antibody drug conjugate, etc.)</li></ul>#EligibleforERP 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 $128,800.00 - $202,700.00 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/International VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): Yes Required Skills: Assay, Assay Development, Automated Liquid Handling Systems, Biochemical Assays, Biophysical Techniques, Biophysics, Biotechnology, Cell Cultures, Communication, Data Generation, Drug Discovery Process, Gas Chromatography-Mass Spectrometry (GC-MS), Interpersonal Communication, Mass Spectrometry (MS), Molecular Cloning, Radioligand Binding Assay, Science, Social Collaboration, Spectrometry Preferred Skills: Job Posting End Date: 07/10/2025 *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:R356609

Senior Scientist, Biochemistry and Biophysics

Job Description The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people. Durham's Technology Transfer Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for implementation of technology transfer process knowledge, post approval support, and post commercial process enhancement activities for pipeline vaccine programs. This position will primarily support the downstream purification process and support functions for the technology transfer of our Company's HPV vaccine drug substance. Additionally, this role will contribute to the performance and results of a department, provide technical guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions. Off-shift and weekend coverage will be required based on business unit needs and specific assignments. The role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management and product franchise. Specific assignments may be focused in one area or span across multiple areas of focus. Travel: 10% of the time Responsibilities may include but are not limited to: &bull; Provide downstream purification process engineering technical/team support for commercial technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates &bull; Actively participate on cross-functional manufacturing teams to advance project goals and deliverables related to the vaccine process &bull; Lead technical studies, projects and author documentation associated with site commercialization efforts &bull; Provide deep SME knowledge for manufacturing investigations support (product and process deviations and complex material-related events) &bull; Collaborate with internal/external partners, e.g. Other Company sites, Global Teams, Procurement, Raw Material & Component Suppliers &bull; Develop effective data analytics methodologies, including statistical process control, and deepening process understanding &bull; Author, review, and/or edit technical documents to support regulatory filings including technical protocols, reports and risk assessments &bull; Author Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes. Managing on-time implementation and close-out to meet project, production and supply timelines. &bull; Support aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls &bull; Evaluate and develop innovative process technologies, continuous process improvements and post launch process enhancements &bull; Provide subject matter expertise support to ongoing manufacturing activities. Position Qualifications: Education Minimum Requirement: <ul><li> Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field with a minimum of two (2) years of relevant experience or a Master of Science Degree. </li></ul> Required Experience and Skills: <ul><li> Experience in vaccine or biologics manufacturing within a cGMP environment </li></ul><ul><li> Experience authoring technical documentation (technical investigations, protocols, reports, or change controls) within a cGMP context </li></ul><ul><li> Proven leader with influence and outstanding communication (written & presentation) skill s </li></ul><ul><li> Demonstrated systematic problem-solving skills </li></ul><ul><li> Possess the ability to multitask and prioritize multiple projects and requests simultaneously </li></ul><ul><li> Experience with project strategic plan development and management </li></ul><ul><li> Ability to foster a collaborative work environment </li></ul> Preferred Experience and Skills: <ul><li> Experience in bulk downstream vaccine or protein purification processes within a cGMP environment </li></ul><ul><li> Experience in the design, operation, and troubleshooting of typical downstream vaccine or biologics manufacturing processes and equipment, including homogenization, microfiltration, chromatography skids, and ultrafiltration. </li></ul><ul><li> Experience with chromatography column packing and support of buffer formulation for the downstream purification process. </li></ul><ul><li> Experience with Manufacturing Execution Systems (MES) enabled by PAS-X, and Delta-V </li></ul><ul><li> Experience with analytical assays; including liquid chromatography, UV- Vis </li></ul><ul><li> Experience with Clean-in-Place and Sterilize/Sanitize-in-Place systems </li></ul><ul><li> Experience with SAP </li></ul><ul><li> Experience with technology transfer methodologies for introduction/launch of a cGMP product </li></ul><ul><li> Experience with on-the-floor cGMP manufacturing support including providing immediate responses on the shop floor to deviations and supply chain interruptions </li></ul><ul><li> Authored complex process change control or deviation investigations </li></ul><ul><li> Experience with validation documentation and execution </li></ul><ul><li> Ability to read Piping and Instrumentation Diagrams is desired </li></ul><ul><li> Lean Six Sigma belt certification </li></ul><ul><li> Experience with process risk assessment tools </li></ul><ul><li> Experience with face-to-face presentation of technically complex subjects to regulatory inspectors or responding to regulatory questions with multiple agencies ( e.g. FDA , EMA) </li></ul>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 $85,600.00 - $134,800.00 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 Required Skills: Adaptability, Applied Engineering, Change Control Management, Computer Technical Support, Data Analysis, Equipment Troubleshooting, Good Manufacturing Practices (GMP), Lean Manufacturing, Personal Initiative, Process Optimization, Professional Integrity, Project Management, Root Cause Analysis (RCA), Technical Writing, Technology Transfer, Troubleshooting, Vaccine Manufacturing, Writing Technical Documents Preferred Skills: Job Posting End Date: 07/22/2025 *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:R356268

Specialist, Purification Technical Engineering HPV (DS4)

Job Description Overview The Associate Director of Federal Tax Audit plays a crucial role in supporting the audit function within the Tax Department, reporting directly to the Director of Tax Audits. This position is responsible for managing the audit process, developing strategies, and collaborating closely with the Internal Revenue Service (IRS) and various internal teams at our Company to ensure compliance and effective audit execution. The Federal Tax Audit Associate Director will be responsible for preparing responses to Internal Revenue Service Information Document Requests (IDRs"), gathering information, preparing analyses to support findings, performing tax research, and reviewing IRS transcripts and filed tax forms. This position requires an individual who can work independently and effectively collaborate with cross-functional teams to identify and gather necessary information. Key Responsibilities<ul><li>Prepare detailed responses to IRS Information Document Requests (IDRs), ensuring all information is comprehensive and well-documented.</li><li>Independently collect and analyze data from internal departments, such as the Tax Department, Controller's Organization, Legal, and various operating divisions throughout our Company to support audit work and findings.</li><li>Review and interpret IRS transcripts, focusing on payment and interest calculations to ensure accuracy and compliance.</li><li>Contribute to strategic audit planning by assessing reserve implications and understanding the compliance process, as well as the impact of current transactions on future audits.</li><li> Prepare reports on the status of audit cycles for management.</li><li>Support the Compliance team with FIN 48 reporting requirements and related documentation.</li><li>Conduct research on tax laws and regulations to support audits findings.</li><li>Collaborate with the Director to research and prepare necessary filings during IRS audits, including statute extensions, repatriation requests, and other audit-related documents.</li><li>Assist in the formal process of administrative appeals as necessary.</li><li>Manage the amendment of state returns resulting from conclusions drawn during Federal audits.</li></ul>Required Qualifications<ul><li>Bachelor's degree in accounting, finance, or a related field.</li><li>A minimum of 4+ years in Tax Audit, Tax Compliance, or Tax Accounting.</li><li>Experience in preparing Federal Forms, particularly Form 1120.</li><li>Strong understanding of tax compliance functions and audit procedures.</li><li>Comfortable engaging directly with the IRS on audit-related matters.</li><li>Excellent analytical, teamwork, and problem-solving abilities.</li><li>Strong written and verbal communication skills, with the ability to convey complex information clearly.</li><li>Proven ability to manage a significant workload and prioritize multiple tasks effectively.</li><li>Demonstrated initiative and ability to work independently.</li><li>An MBA, JD/LLM, CPA or relevant Master's degree is a plus.</li></ul>#eligableforerp VETJOBS 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: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Required Skills: Accounting, ASC 740, Budget Preparation, Corporate Tax Compliance, Detail-Oriented, Finance, Ideas Generator, International Tax Consulting, International Tax Planning, Preparation of Financial Reports, Relationship Building, Tax Audits, Tax Compliance, Tax Law, Tax Minimization, Tax Strategies, Team Leadership, Transfer Pricing Preferred Skills: Job Posting End Date: 07/21/2025 *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:R356254

Associate Director - Federal Tax Audit

Job Description The primary function of the Clinical Research Associate (CRA) I position is to assist with clinical study operations as well as monitor clinical field and laboratory studies that will support the regulatory approval of new companion animal and livestock products. These studies will be conducted in compliance with the requirements of Good Clinical Practice (GCP). The Clinical Research Associate I acts as a point of contact with investigators and study site personnel, as well as manages all administrative aspects of a clinical study. The CRA, in collaboration with the Clinical Study Team Leader (CSTL) and other CRAs, may assist with the design, conduct and reporting of clinical studies according to GCP. MAJOR ACTIVITIES AND RESPONSIBILITIES Study Monitoring and Management:<ul><li>Assist other CRAs and/or the CSTL with site visits (e.g., contract research organizations (CROs), veterinary clinics, farms, etc.) to ensure compliance with the study protocol, Veterinary International Conference on Harmonization (VICH)/Good Clinical Practice (GCP), Sponsor Standard Operating Procedures (SOPs) and applicable regulatory requirements.</li><li>Evaluate the performance of the trial at the site, ensuring timely monitoring of proper data.</li><li>Oversee the consent process to ensure that it meets ethical and regulatory standards in accordance with VICH/GCP.</li><li>Ensure that adverse events are documented and reported according to the applicable procedures and timelines.</li><li>Assist with preparation of the study file and study documentation such as notebooks and Case Report Forms, in collaboration with other CRAs and the Data Manager.</li><li>Organize the shipment and submission of study materials and samples as appropriate. Assist with overseeing the test material inventory and ship additional study material to the site(s), as needed.</li><li>Assist with the QC of data (paper or within an electronic data capture system), as needed.</li></ul>Data Collection and Management:<ul><li>Monitor and verify the accuracy of clinical data collected during the study, in accordance with ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate).</li><li>Review and resolve discrepancies in clinical data with site personnel.</li><li>Ensure the storage of study documents is secure and in compliance with the study protocol, SOPs, and applicable regulatory requirements.</li><li>Assist in database creation and testing as required. Perform data entry and data QC as needed.</li></ul>Regulatory Compliance (FDA-CVM, USDA-CVB, EMA):<ul><li>Ensure all necessary site and investigator documents are up to date and compliant with local laws and regulations.</li><li>Assist with the preparation and the reviewing of submissions to regulatory bodies.</li><li>Support quality assurance audits and regulatory authority inspection activities, as needed.</li></ul>Communication and Reporting:<ul><li>Serve as a point of contact between the site and the sponsor and ensure an accurate and complete log of all contacts with the study site.</li><li>Prepare monitoring visit reports and other documentation in a timely and accurate manner.</li><li>Attend clinical study team (CST) meetings and provide updates on site status.</li></ul>Problem Solving:<ul><li>Identify and escalate potential study issues and participate in the problem-solving process.</li><li>Collaborate with team members and site personnel to ensure the smooth running of trials.</li><li>Provide support to sites as needed to handle issues such as patient recruitment or retention.</li><li>Assist with implementation of improvements in the clinical research and development processes.</li></ul>Training and Development:<ul><li>Participate in ongoing training in clinical trial management and regulations.</li><li>Support training sessions on GCP, SOPs, regulatory compliance, and specific study protocols.</li></ul>QUALIFICATION PROFILE Education: Bachelor's degree or equivalent in a relevant biological field Skills Required:<ul><li>Good written and oral command of English language</li><li>Good communication skills.</li><li>A strong ability in scientific writing.</li><li>Ability to travel (up to 50% of the time) as required to various study sites and collaborators e.g., CROs, veterinary clinics, farms, etc.</li></ul>Competencies Required:<ul><li>A minimum of six (6) months of experience in clinical research or equivalent role.</li></ul>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 $63,900.00 - $100,500.00 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: 50% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): n/a Required Skills: Adaptability, Adaptability, Clinical Data, Clinical IT, Clinical Quality Assurance, Clinical Research, Clinical Site Management, Clinical Site Monitoring, Clinical Testing, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trial Regulations, Clinical Trials Monitoring, Clinical Trial Support, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Livestock Management, Management Process, Patient Recruitment, Pharmaceutical Quality Assurance, Quality Assurance (QA) Standards, Regulations, Regulatory Compliance {+ 3 more} Preferred Skills: Job Posting End Date: 07/10/2025 *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:R355527

Clinical Research Associate Specialist (Hybrid)

Job Description Position Overview The West Point Quality organization ensures our products are manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our West Point campus, internal manufacturing facilities, external contract manufacturers and suppliers we create a global manufacturing network dedicatedto deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The West Point Quality organization is a team of leaders who exemplify and cultivate our company's enterprise leadership skills and ways of working, fostering a culture of collaboration, innovation, and accountability across all levels of the organization while maintaining alignment with the company's values and strategic vision. The Quality Engineering Associate Director serves as a quality leader accountable for the quality oversight of maintenance, equipment reliability, validation and engineering organizations including service providers supporting West Point Manufacturing and Quality Control laboratories. The Associate Director is responsible for implementing Divisional, Company and Site policy, procedures and guidelines and for discharging Quality Operations responsibilities. These activities include involvement in all Quality aspects associated with deviation management, change control, and compliance. They act as key regulatory compliance liaison to interface with regulatory agencies during inspections. They are a member of the Engineering, Maintenance and Utilities (EMU) Leadership Team and direct Quality activities associated with the team. Reporting to the Core Site Service E2E Quality Director, the incumbent will lead establishment of the organizational model for Quality Engineering and will be responsible for development of the key responsibilities, performance indicators, and actions to achieve a sustainable organization design across the West Point site. Essential Functions and Responsibilities (Includes, but are not limited to) The Associate Director, Quality Engineering Lead, is responsible for:<ul><li>Establishing and leading the Quality Engineering Group at the West Point site. </li><li>Site Topic Lead for the Facilities, Utilities, Equipment and Manufacturing Controls QMS topic for the site. Maintains Quality Management systems and drives sustained compliance.<ul><li>Point person for coordination and deployment of quality oversight procedures and expectations for the organization (e.g. routine maintenance and capital projects)</li><li>Ensuring that the Governing procedures are robust and aligned to Quality Management System and Global Procedures and the procedures enable the organization to be successful.</li></ul></li><li>Provide Quality review and approval of EMU Standard Operating Procedures.</li><li>Actively ensures multi-disciplinary teams work efficiently to drive to thorough root cause analysis and effective and timely closure of investigations. Drives efforts to reduce deviations.</li><li>Ensures that personnel operate within established policies/procedures of the Division and Corporation and comply with all applicable governmental regulations (GMP, EPA, etc.), both domestic and foreign.</li><li>Coach, teach, connect applicability and importance of quality systems/GMPs.</li><li>Management and support for Quality capital planning/management.</li><li>Responsible for inspection readiness and regulatory inspection support across West Point Engineering, Maintenance and Utilities scope.</li><li>Ensure that short term and long-term team objectives are established for the Quality Engineering team and achieved while reliably supplying quality product.</li><li>Provide tactical and strategic direction to the Quality Engineering team including leadership influence within the cross functional team of support.</li><li>Promote the behaviors and principles that drive continuous improvement </li><li>Develop and continue to drive improvement to key performance indicators and business outcomes within the Quality Engineering team.</li><li>Operates in a safe and efficient manner and in compliance with our Manufacturing Division Safety and Health Policy.</li><li>People Management - Responsible for creating, hiring and sustaining a highly engaged workforce through utilization of our company's Enterprise Leadership Behaviors and Inclusion. Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation.</li><li>Stays current on emerging trends, technologies and regulatory developments.</li></ul>Qualification and Skills Requirements (Includes but are not limited to) Minimum Education Requirements and Experience: <ul><li>Bachelor's Degree in Science, Engineering, or another technical field with seven (7) years' experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain OR </li><li>Master's Degree in Science, Engineering, or another technical field with four (4) years' experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain</li></ul> Required Experience and Skills: <ul><li>Applicable experience, strong understanding and knowledge of relevant quality systems expectations in the biotechnology or vaccine industry.</li><li>Ability to interpret and relate quality standards for implementation and review.</li><li>Strong working knowledge of Engineering, Maintenance, Manufacturing support systems, and associated business processes.</li><li>Strong operational management capabilities, adept at overseeing various operational aspects to drive efficiency and effectiveness.</li><li>Ability to work independently while fostering collaboration in team settings and matrix organizations to achieve common goals.</li><li>Highly skilled in listening to diverse perspectives, developing impactful solutions, and advocating for effective positions through influence.</li><li>Excellent communication, leadership, and problem-solving skills, with the ability to distill complex data and actionable insights and recommendations.</li><li>Very skilled at organizing complex topics, strong project management skills, able to handle multiple tasks concurrently</li><li>Adapts to rapidly changing business needs, fostering a flexible and responsive approach to challenges</li><li>Fosters positive, transparent and productive relationships across various stakeholders</li><li>Proven history of challenging the status quo of business standards and processes with the ability to propose solutions</li><li>Understanding and experience in various business methodologies (ex. Lean thinking, Agile methodology, Design thinking, Six sigma, etc.)</li></ul> Preferred Experience and Skills: <ul><li>Experience in quality organizations and/or manufacturing operations, with a solid understanding of industry practices</li><li>Familiarity with plant audits and supplier audits, showcasing an awareness of compliance and quality assurance processes.</li><li>Strong sense of accountability, with a proven ability to drive results and learn from past experiences to inform future actions.</li><li>Demonstrates sound judgment in gathering and analyzing pertinent data to make independent, timely decisions.</li><li>Skilled in communicating effectively, influencing stakeholders, and appropriately escalating issues and decisions when necessary.</li></ul>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: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Required Skills: Achieving Objectives, Adaptability, Agile Methodology, Business Process Management (BPM), CAPA Management, cGMP Regulations, Compliance Analysis, Continual Improvement Process, Corrective Action Management, Deviation Management, People Management, Quality Assurance (QA), Quality Control Management, Quality Engineering, Quality Manuals, Quality Operations, Quality Risk Management, Quality Standards, Strategic Thinking, Team Management Preferred Skills: Regulatory Management Job Posting End Date: 07/11/2025 *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:R356067

Assoc. Dir., Quality Engineering

Job Description Position Description: The External Manufacturing Vaccine Drug Product Technical Operations (ExM Vaccine DP TO) organization is seeking a highly motivated individual for a Sr. Specialist Engineering position. ExM Vaccine DP TO is accountable for technology transfers and commercial production of sterile drug product at our Company's External Partners (EPs). This person will have the opportunity to participate and lead activities in all these areas. Responsibilities include: <ul><li>Work with External Partners to achieve business goals and to establish a common culture that benefits both our company, External Partners, and patients</li><li>Responsible for technical activities for the commercial manufacturing process at the External Partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events </li><li>Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.</li><li>Provide on-site coverage at External Partner in support of Commercial and / or Tech Transfer Person In Plant Activities</li><li>Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations, Quality, and External Partners</li><li>Ensure that External Partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory</li><li>Responsible for participation in creating, sharing, and adopting best practices and business process strategies</li></ul> Position Qualifications : Education Minimum Requirement: <ul><li>Bachelor's degree in chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field. </li></ul> Required Experience and Skills: <ul><li>Minimum of 4 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance</li><li>Travel will be a requirement of this position at up to 50%</li><li>Strong communication and teamwork skills</li></ul> Preferred Experience and Skills: <ul><li>Experience in sterile / aseptic manufacturing</li><li>Demonstrated ability to independently manage projects/work to schedule/deadlines</li><li>Statistics experience</li><li>Experience in deviation management and/or change control and/or equipment support, and/or project management.</li></ul>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: 50% Flexible Work Arrangements: Remote Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Required Skills: Applied Engineering, Business Management, Business Performance Management, Business Processes, Chemical Biology, Enterprise Operations, GMP Compliance, Management Process, Manufacturing Engineering, Manufacturing Processes, Mechatronics, New Product Introduction Process, Process Improvement Management, Process Improvement Projects, Project Management Preferred Skills: Automation Engineering, Biological Engineering, Business Operations, Business Process Development, Business Process Improvements, Chemical Engineering, Communication, Documentations, Engineering Technology, Equipment Maintenance, Lean Process Improvements, Maintenance Management, Maintenance Plans, Manufacturing, Operations Management, Partnership Development, Plant Care, Policy Development, Process Improvements, Quality Control Systems, Quality Management, Regulatory Compliance, Regulatory Documents, Teamwork, Waterfall Model Job Posting End Date: 07/17/2025 *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:R355569

Senior Specialist, Engineering - External Manufacturing Vaccine Technical Operations

Job Description Job Description We are seeking a Growth and Improvement minded Mechanical Operations Technician that can help drive our Strategic Operating Priorities.<ul><li>Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs</li><li>Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)</li><li>Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape</li><li>Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world</li><li>Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us</li></ul> Key Responsibilities Essential Functions <ul><li> Operates automated and non-automated packaging equipment according to Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs) </li><li> Prepares packaging equipment for production according to Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs) </li><li> First responder to challenges with packaging equipment </li><li> Completes equipment set-up and dial on packaging equipment: Product flow alignment | Container size change adjustment | Selection of correct qualified recipe parameters | Set-up of qualified vision/inspection systems and verification of proper functionality of detection/rejection systems </li><li> Ensure all tasks are completed in a safe manner </li></ul> Automated and Non-Automated Packaging Equipment | SOPs and GMPs <ul><li> Load packaging material into process flow </li><li> Move packaging material to different locations on the packaging line </li><li> Inspect material rejected from equipment for defects prior to repackaging </li><li> Waste material which cannot be repackaged </li><li> Utilizing TrackSys data, trend and escalate equipment performance issues to maintenance and reliability teams as appropriate </li><li> Document activities within applicable batch documentation </li><li> Clear/Clean packaging equipment </li><li> Inspect packaging equipment post cleaning </li><li> Setup and adjust the equipment </li><li> Use appropriate tools </li><li> Ensure proper alignment and clearances </li></ul> First Responder to Packaging Equipment Challenges <ul><li> Determine if the challenge is due to the equipment or the component being run on the equipment </li><li> Gather/Document key information at time of the challenge to aide in current and if necessary, future trouble shooting activities </li><li> Make minor equipment adjustments as needed to return the equipment to a functional state. </li><li> Escalate to Maintenance when the challenge/issue has not been resolved within the expected timeframe </li></ul> Safety <ul><li> Follow established safety standards while following SOPs and GMPs </li><li> Actively take accountability for personal safety as well as the safety of others </li><li> Identify, report, and document unsafe conditions </li><li> Recognize and utilize safety equipment </li></ul> Education <ul><li> High School diploma or equivalent (GED) with one (1) year or more experience with focus in industrial, pharmaceutical, food industry, and/or laboratory equipment OR an applicable associate's degree </li></ul> Preferred <ul><li> Experience with lock-out-tag-out (LOTO) </li></ul> Shift and Hours <ul><li>2nd shift 3:30 PM to 12:00 AM Monday to Friday</li><li>Work overtime on weekends</li></ul>#MSJR 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: 2nd - Evening Valid Driving License: No Hazardous Material(s): N/A Required Skills: Analytical Problem Solving, Biological Manufacturing, Cleanroom Gowning, Computer Literacy, Equipment Maintenance, GMP Operations, Good Manufacturing Practices (GMP), Laboratory Processes, Machinery Operation, Maintenance Processes, Manufacturing Quality Control, Packaging Operations, Pharmaceutical Manufacturing, Production Scheduling, Shift Work, Standard Operating Procedure (SOP) Writing, Troubleshooting, Vaccine Production Preferred Skills: Job Posting End Date: 07/22/2025 *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:R355708

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Associate Director - Federal Tax Audit

Assoc. Dir., Quality Engineering

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