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Summary Location: #LI-Hybrid Job Description Summary The Director, Data Strategy & Value Delivery serves as a leadership partner within the US Data Strategy & Governance organization at Novartis. This role supports DS&G leadership in shaping, governing, and advancing the US enterprise data agenda, ensuring priorities are translated into clear plans, disciplined execution, and measurable value. The Director is accountable for driving operational rigor and leadership effectiveness across Data Strategy & Governance. Core responsibilities include managing US data councils and governance forums, overseeing team budgets and investment tracking, coordinating high priority enterprise data initiatives, and providing direct support to DS&G leadership through planning, synthesis, and execution management. The role acts as an integrator across governance, finance, technology, and analytics teams-maintaining alignment, surfacing risks and tradeoffs, and ensuring sustained progress on critical data priorities. The Director influences outcomes through structure, insight, and leadership presence rather than formal authority. The role enables effective decision making and execution across DS&G while partnering closely with IDS (Insights & Decision Science), Commercial, Medical, Market Access, and enterprise stakeholders to ensure data investments are governed, prioritized, and delivering intended impact. This position will be located at East Hanover, NJ site and will not have the ability to be located remotely. This position will require 15% travel as defined by the business (domestic and/ or international). About the Role Key Responsibilities:<ul><li>&bull;Enable effective prioritization, decision-making, and execution across the US Data Strategy & Governance agenda</li><li>&bull;Lead planning, facilitation, and oversight of US Data Strategy & Governance councils and forums, ensuring decision readiness, clear outcomes, and follow-through</li><li>&bull;Translate DS&G leadership priorities into structured plans and milestones; monitor progress and surface risks, dependencies, and trade-offs</li><li>&bull;Own DS&G budget and investment oversight, including planning, tracking, forecasting, and value realization, in partnership with finance and leadership</li><li>&bull;Drive coordination across high-priority, cross-enterprise data initiatives to ensure alignment and delivery of agreed outcomes</li><li>&bull;Establish and maintain governance mechanisms that support prioritization, investment oversight, and accountability</li><li>&bull;Serve as an integration point across DS&G pillars to enable alignment and shared ownership</li><li>&bull;Prepare and deliver concise executive-level materials and updates on priorities, progress, risks, and value realization</li><li>&bull;Strengthen DS&G operating rhythms, forums, and ways of working to improve leadership effectiveness and execution discipline</li><li>&bull;Represent Data Strategy & Governance in cross-functional engagements with IDS, Commercial, Medical, Market Access, and enterprise partners</li><li>&bull;Influence outcomes through insight, structure, and leadership presence in a matrixed environment without formal authority</li><li>&bull;Ensure data investments are governed, prioritized, and delivering measurable business value aligned to US enterprise objectives</li></ul>Essential Requirements: Education: Bachelor's degree required; advanced degree (MBA, MS, PhD, or equivalent) preferred<ul><li>Strong financial and business acumen, with experience in budget oversight, investment governance, and value realization</li><li>Understanding of data strategy, governance, and external data partnerships</li><li>Demonstrated ability to operate as a senior individual contributor supporting executive leaders, councils, and enterprise decision forums. </li><li>Proven capability to influence outcomes through insight, structure, and leadership presence in complex, matrixed environments</li><li> Experience working within regulated industries (e.g., life sciences, healthcare) strongly preferred </li><li>Proven success as a senior individual contributor delivering complex, high-impact initiatives in a complex matrix environment</li><li>Demonstrated ability to operate effectively in large, matrixed organizations without formal authority</li></ul>Desirable Requirements:<ul><li>Proven success as a senior individual contributor delivering complex, high-impact initiatives</li><li>Demonstrated ability to operate effectively in large, matrixed organizations without formal authority</li></ul>The salary for this position is expected to range between $185,500.00 and $344,500.00 year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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Director, Data Strategy & Value Delivery

Summary #LI-Hybrid Position can be based in the US (Cambridge, MA or Emeryville, CA). Are you passionate about advancing pharmaceutical research and ensuring drug safety at Novartis? The Preclinical Safety (PCS) department at Novartis BioMedical Research (BR) is seeking an experienced Genetic Toxicologist to join our dynamic team. More than 100,000 people across 140 countries are working for Novartis to discover, develop, and successfully market innovative products to prevent and cure diseases, ease suffering, and enhance the quality of life. As a Genetic Toxicology expert at Novartis, you will play a key role in supporting non-clinical safety assessment throughout drug discovery and development, as well as for established medicines, with state-of-the-art regulatory compliance. Utilizing your expertise, you will collaborate with cross-functional teams to ensure the delivery of high-quality and compliant research. About the Role Key Responsibilities: <ul><li>Conduct and monitor genetic toxicology studies and interpret data to support drug discovery and development programs spanning all therapeutic modalities and disease indications.</li><li>Provide expert opinions on genetic toxicity assessments to support drug discovery and development project teams, regulatory submissions and due diligences, and life-cycle management of established medicines.</li><li>Develop and implement state-of-the-art innovative technologies and systems for regulatory and investigative genetic toxicity testing across all therapeutic areas and modalities.</li><li>Maintain state-of-the-art scientific and regulatory expertise in Genetic Toxicology.</li><li>Lead cross-functional teams; represent the PCS line function on internal and external boards; actively share and communicate information back to the Genetic Toxicology team.</li><li>Engaging and collaborating with key internal and external customer partners.</li><li>Ensure compliance with relevant regulatory guidelines and standards.</li><li>Stay at the forefront of emerging technologies in genetic toxicology.</li></ul>Essential Requirements:<ul><li>PhD, DVM or equivalent</li><li>Strong knowledge in genetic toxicology.</li><li>Excellent knowledge of the drug development process.</li><li>Minimum of 15 years of demonstrated experience in regulatory and investigative genetic toxicology is strongly preferred.</li><li>Work experience in pharmaceutical companies or CRO Laboratories servicing pharmaceuticals.</li><li>Extensive experience in health authority interactions.</li><li>Strong data exploration, analytical skills and commitment to scientific excellence.</li><li>Exceptional analytical, communication and collaboration skills</li></ul>The salary for this position is expected to range between $185,500 and $344,500 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here .<ul></ul>Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Director - Genetic Toxicology Expert

Summary #LI-Onsite Location: Durham, NC ***The Site Utility Lead is an Associate Director level role*** If you're energized by owning the systems that keep a manufacturing campus safe, reliable, and ready for what's next-this is your opportunity to lead from the front. As the Site Utility Lead, you will lead a site-based team of utility and electrical engineers and technicians supporting continuous operations across a two-site manufacturing campus, with accountability for the reliable operation, integration, improvement, and lifecycle planning of critical building and utility infrastructure. You will partner across engineering, quality, validation, and operations to enable day-to-day performance and future growth through capital project support, disciplined change control, corrective and preventive actions, inspection readiness, and clear key performance indicator-driven improvements-while helping advance site decarbonization initiatives aligned with Novartis sustainability goals. About the Role Key Responsibilities:<ul><li>Lead and mentor utility and electrical engineers and technicians supporting round-the-clock manufacturing operations.</li><li>Ensure reliable, efficient operation of building and utility infrastructure across a two-site manufacturing campus.</li><li>Plan and deliver utilities support for current and future capital projects and site objectives.</li><li>Coordinate site shutdowns, repairs, and small infrastructure projects to minimize operational disruption.</li><li>Optimize resource sharing across sites to maximize capability and reduce total operating costs.</li><li>Manage external service providers, ensuring training, qualification, and safe execution of contracted work.</li><li>Lead site decarbonization initiatives aligned to Novartis sustainability goals.</li><li>Define, monitor, and improve facility and utility key performance indicators; present regular performance and budget reports.</li><li>Own change control and corrective and preventive actions for assigned systems; lead deviation investigations as needed.</li><li>Represent utilities engineering during regulatory audits, ensuring maintenance readiness and technical support for inspection responses.</li></ul>Essential Requirements:<ul><li>Bachelor of Science degree in engineering or a closely related technical discipline.</li><li>Minimum 10 years of relevant experience in regulated biotechnology or biopharmaceutical manufacturing environments.</li><li>3+ years of demonstrated people leadership experience, preferably in site or utilities engineering functions.</li><li>Strong knowledge of health, safety, and environmental regulations and current Good Manufacturing Practice requirements.</li><li>Proven ability to lead through complex, high-pressure situations with sound judgment and structured decision-making.</li><li>Demonstrated success collaborating across quality, validation, operations, and engineering teams in fast-paced settings.</li><li>Excellent written and verbal communication skills, including technical documentation and leadership-level presentations.</li><li>Proficiency using standard office software, building management systems, and computerized maintenance management systems.</li></ul>Desirable Requirements:<ul><li>Experience leading site sustainability or decarbonization initiatives in an industrial or regulated manufacturing environment.</li><li>Experience supporting utilities and infrastructure for continuous operations across multi-building or multi-site manufacturing campuses.</li></ul>Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $138,600 and $257,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here. Company will not sponsor visas for this position. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Site Utility Lead

Summary Help reimagine cancer care by shaping how our Radioligand Therapies (RLT) reach more patients-safely, reliably, and faster. At Novartis, we're pioneering the future of treatment through the fusion of nuclear medicine and precision oncology. The QC Microbiologist supports all technical aspects related to quality control testing readiness, including QC reagents and materials management, equipment preparation and daily cleaning and maintenance activities, sample management and QC testing, and documentation completion and review in full compliance with GMP regulation, procedures, and product specifications. Location: Indianapolis, IN #LI-Onsite Shift: Two positions available. Weekend 2nd shift - Thursday to Sunday About the Role Key Responsibilities:<ul><li> Finished Product testing, Environmental Monitoring and Sterility QC testing, and reporting of the QC results. </li><li> Escalation in case of non-conformances and deviations and manage these quality incidents as per AAA procedures. </li><li> Support deviation investigations, OOS/OOT/OOE investigations, CAPA follow up and implementation, and Change Control management, including procedure and form revisions. </li><li> Participation in assigned qualification/validation activities, as necessary. </li><li> Responsible for successful on time completion of required training curricula comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications, Testing and specifications, and other relevant training including HSE for the specific role. </li><li> Prepares applicable documents, forms, and records such as analytical batch records and follows Good Documentation Practices. </li><li> Support internal and external Audits and Inspections, as required. </li></ul>Essential Requirements:<ul><li> Education: Bachelors' degree required in relevant Scientific discipline (e.g Chemistry, Microbiology) strongly preferred. In lieu of a degree, 5 years of relevant experience in similar role in Pharma/Manufacturing sector in analytical lab may be considered. </li><li> 1 year experience in cGMP or aseptic environment preferred. </li></ul><ul><li> Knowledge of cGMP regulations and FDA guidance applicable to Quality Control for product and Environmental Monitoring testing, as well as Aseptic techniques. </li><li> Practical experience with Microbiology method verification and routine testing practices, EM Monitoring and basic knowledge of method/equipment validation principle and methodologies. </li><li> Ability to interpret analytical data and convert into technical documentation. </li><li> Basic knowledge and understanding of aseptic principles and techniques. </li></ul> Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $89,600 and $166,400/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

QC Microbiologist

Summary #LI-Hybrid Novartis has an incredible opportunity for a talented individual to join our team as an Associate Director, Clinical Sciences. As the Associate Director, Clinical Sciences, you will support US efforts in the planning, execution and reporting of Innovative Medicine US (IM US) clinical trials The ideal location for this role is the East Hanover site but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to specific East Hanover site for periodic live meetings will be at the employee's expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 20% travel. About the Role Responsibilities include: &bull; Responsible for the implementation of designated clinical trials including investigator selection, patient recruitment, preparation of trial related documentation, TMF maintenance, and organizing Ethics Committee submissions. &bull; May provide strategic input to protocol design based on operational feasibility and execution strategy as appropriate &bull; Accountable for the accuracy and timeliness of trial information in all trial databases and tracking systems. &bull; Serves as clinical trial leader for US Medical Affairs Trials (including Phase I-IV, Managed Access, Investigator Initiated, Research Collaborations and Registries). &bull; May serve as disease area(s) lead in support of Therapeutic Area Program Lead, Clinical Sciences. &bull; Interfaces with the disease area(s), global and US clinical team members, clinical operations, scientific operations, regulatory affairs, drug supply, data management, finance, quality, compliance, and other relevant functional areas. &bull; Liaises with study investigators, site research staff, and field-based colleagues to support clinical studies. Point of first contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials. &bull; Organizes investigator's start-up meeting and study site initiation meetings. &bull; Drives study enrollment, plan advisory boards, and perform external study feasibility with investigators. &bull; May independently develop strategic trial execution plan (e.g., recruitment retention, contingency plans) and timeline commitments for the US as appropriate. &bull; Maintains project files including: ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment. &bull; Understands and complies with company SOPs and GCPs; contributes to continuous improvement in SOPs and local Working Practices. &bull; Responsible for the initial and subsequent drug supply across trials within a therapeutic area in collaboration with the Local Drug Supply Manager. &bull; Contributes to the preparation and review of clinical program documents (PowerPoint presentations, IND annual report, Health Authority (HA) briefing books, clinical study protocol, regulatory documents, clinical study reports, (CSR) and submissions) and other study related documents assuring quality and consistency. &bull; Supports the development, management and tracking of trial budgets working closely with the appropriate partners. &bull; Facilitates vendor selection and performance. Manages all vendors (CRO, Central lab etc.): definition of responsibilities, communication plan, divisions of responsibility, milestones, , review monthly status reports, and the interactive management of all vendors to ensure project success. &bull; Coordinates the movement of laboratory samples and the resulting data when central laboratory facilities are used. &bull; Reviews all SAEs, ensures Medical Director sign-off, that sites are notified, and that all company procedures are complied with. &bull; Supports all scientific aspects of clinical trial(s) and program level activities as assigned. &bull; Provides mentorship to Managers and Specialists, Clinical Sciences, to ensure that their role and contribution is optimized. Essential Requirements &bull; Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution. &bull; A minimum of 8 years of significant clinical research or research monitoring experience that provides the required knowledge, skills and abilities and experience mentoring or training others. In some cases, an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered. &bull; In some cases, an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered. &bull; Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices, and applicable Standard Operating Procedures. &bull; Ability to mentor and train other clinical associates in a positive and effective manner. &bull; Ability to evaluate medical research data and proficient knowledge of medical terminology. &bull; Effective oral and written communication skills, with the ability to communicate effectively with medical personnel. &bull; Effective presentation skills. Effective organizational and time management skills. &bull; Ability to utilize problem-solving techniques applicable to constantly changing environment. The salary for this position is expected to range between $152,600 and $283,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here . Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Associate Director, Clinical Sciences

Summary The Maintenance Technician is responsible for performing corrective and preventative maintenance and support services for the building(s) and all equipment for a GMP Radioligand Therapies Production Facility. Responsible for reliable, efficient, and sustained operation of the facility and all equipment. Additionally supports current project operations and site goal objectives and ensures compliance with regulatory, corporate, and site requirements related to their functional area. Location: Onsite Please note this is a 2nd shift position (6pm - 6am; 2x2x3) About the Role Major accountabilities: &bull; Adhere to Novartis Quality Policies and procedures as they pertain to the position to ensure that all products are safe, pure, effective and of the highest quality. &bull; Perform a wide range of maintenance repair activities on production equipment, lab equipment and building management systems. &bull; Assist in troubleshooting and repair of process equipment (example: containment isolator systems, filling line equipment and associated utility connections) which may include mechanical, electrical wiring, pneumatics, motors, pumps, vacuum systems, HVAC, control systems, compressed gases, filling line, under little to no supervision. &bull; Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs. &bull; Support 24x7 site-based operations after startup. &bull; Write/revise accurate operational procedures, training documents and maintenance procedures for various production and utility systems. &bull; Provide radiation safety program support, responsible for calibration and functionality of all radiation detection equipment &bull; Completes Equipment Work Order Thoroughly, and Accurately and Documents them in the System &bull; Supply information and technical data for securing spare parts. &bull; Provide responsive customer support with emphasis on customer satisfaction. &bull; Perform startup and commissioning activities as required. &bull; Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs &bull; Perform preventative and corrective maintenance on manufacturing process related equipment within a cleanroom environment. &bull; Complete and provide accurate documentation, as required in cGMP operations. &bull; Oversee work and provide training of less experienced maintenance technicians and/or new technicians. &bull; Other related duties as assigned. &bull; Use of CMMS system for documentation of relevant work. The salary for this position is expected to range between $47,500 and $88,300 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Minimum Requirements: &bull; High School diploma or equivalent is required; Bachelor's Degree is preferred. &bull; 1+ years of relevant hands-on plant maintenance experience in a regulated GMP environment is required. &bull; Previous aseptic fill/finish and/or radio pharmacy experience is preferred. &bull; Previous pharmaceutical or medical device experience is preferred. &bull; Completed training in radioactive or hazardous materials environment is preferred. &bull; Must be able to adhere to all applicable procedures, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.) &bull; Experience working in a team environment, with excellent communication and organizational skills. &bull; Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS) or similar system. &bull; Ability to climb ladders and lift up to 50 lbs. &bull; Wear and work in protective clothing, including respiratory protection, confined space entry and clean room environments. &bull; Must be flexible to work nights, weekends, and holidays as required. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Maintenance Technician

Summary #LI-Onsite #Novartis #NovartisCareers #ThriveTogether #ManufacturingCareers #BiopharmaJobs #MaintenanceLeadership #GeneTherapyJobs Location: This role is based in Durham, NC, United States. Novartis is unable to offer relocation support: please only apply if accessible. Ready to lead the team that keeps a fast-paced Gene Therapies site running safely, reliably, and audit-ready every day? As a Senior Manager, Maintenance, you will shape and elevate the site's maintenance program across critical manufacturing, utility, and laboratory assets-building strong systems, developing talent, and driving disciplined planning and execution. You will partner closely with operations, quality, and validation teams, strengthen vendor strategies, and ensure inspection readiness, making a direct impact on site performance and the patients who rely on our therapies. About the Role Key Responsibilities:<ul><li>Lead and continuously improve the site maintenance strategy across manufacturing, utilities, quality control, and technical research & development (TRD) equipment</li><li>Plan, execute, and document preventive and corrective maintenance activities to ensure asset reliability and compliance</li><li>Develop, implement, and optimize site maintenance procedures and standards to support safe and consistent operations</li><li>Oversee site shutdown planning and execution to minimize downtime and protect critical manufacturing schedules</li><li>Manage maintenance budgets, track expenses, and drive cost-effective solutions without compromising quality or safety</li><li>Establish, monitor, and improve key performance indicators for maintenance and calibration programs</li><li>Serve as the site subject matter expert for maintenance and calibration during regulatory inspections and audits</li><li>Build, train, and develop a high-performing maintenance team with strong cross-training and succession planning</li><li>Own the site maintenance management system, ensuring accurate master data, work orders, and spare parts programs</li><li>Partner with global engineering and external vendors to implement best practices and strengthen service strategies</li></ul>Essential Requirements:<ul><li>Bachelor of Science degree in engineering or related field, plus 9 years of relevant industry experience; or 13 years of equivalent industry experience in lieu of a degree (GMP biotech/biopharma industry preferred)</li><li>Proven experience in maintenance leadership within a regulated biotechnology or biopharmaceutical manufacturing environment</li><li>Demonstrated people management experience, including coaching, performance management, and team development</li><li>Strong knowledge of health, safety, and environmental regulations, including current Good Manufacturing Practice requirements</li><li>Ability to plan, prioritize, and resolve complex operational issues in a fast-paced, high-pressure environment</li><li>Strong collaboration skills with cross-functional teams including quality, validation, and manufacturing operations</li><li>Proficiency with computerized maintenance management systems, building management systems, and standard office software tools</li><li>Demonstrated success partnering with external vendors and global engineering teams to implement maintenance best practices</li></ul>Desirable Requirements:<ul><li>Experience leading maintenance programs within gene therapy, biologics, or advanced pharmaceutical manufacturing facilities strongly preferred.</li></ul>Novartis Compensation & Benefits Summary: The salary for this position is expected to range between $114,100 and $211,900 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here Company will not sponsor visas for this position. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Senior Manager, Maintenance

Summary About the role: #LI-Onsite Help us ensure that safe, effective and innovative treatments reach patients as quickly as possible! The Clinical Program Leader (CPL) / Senior Clinical Program Leader (Senior CPL) will play a critical role in overseeing the planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. About the Role Key Responsibilities:<ul><li>Provides strategic medical guidance for the development of new oncology agents that are in preclinical development, typically beginning at the development candidate (DC) phase. Accountable for Translational Clinical Oncology (TCO) aspects of one or more global drug development programs. Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports. </li><li>Evaluation of external opportunities for potential business development purposes</li><li>Responsible for creating a clinical development strategy for new oncology agents. The development strategy combines the Clinical Program Leader's (CPL) medical knowledge with the expertise of colleagues in a wide range of other disciplines (e.g. Biomarkers, Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy. Although registration studies are not within the responsibility of TCO, the CPL in TCO must provide an early clinical development strategy that foresees and supports subsequent registration trials</li><li>Leads Biomedical Research Program Teams (BPTs), beginning at the time of approval to conduct Good Laboratory Practices (GLP) toxicology studies to enable the start of clinical development, and continuing through those clinical trials. May lead multiple global project teams. </li><li>Support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements.</li><li>Responsible for development of the Integrated Development Plan (IDPA).</li><li>Integrates preclinical information (pharmacology, toxicology, pharmacokinetics) and interprets its implications for clinical development, as articulated in the Investigator's Brochure and first-in-human protocol. </li><li>Collaborates with clinical scientists to develop clinical protocols for TCO compounds and to develop the instruments needed to implement, interpret and report them (e.g., case report forms, report and analysis plans, clinical study reports). </li><li>Applies his or her medical knowledge to guide the safe, ethical and efficient conduct of the trials under his or her responsibility. He or she is knowledgeable in Good Clinical Practice guidelines and Novartis Standard Operating Procedures and strives to maintain compliance with them. </li><li>Liaises with outside experts, investigators, and regulatory authorities in the field of oncology, and represents his or her projects to those groups and authorities. Fosters communication with key opinion leaders and collaborating investigators. Acts as the medical monitor for one or more global clinical studies. Writes and reviews abstracts/manuscripts, etc. for presentation/publications at internal/external meetings. Participates in task forces to support continuous improvement and other management objectives. Mentors and serves as an educational resource across Novartis. Acts as a key resource for less experienced CPLs in TCO.</li></ul>Essential Requirements:<ul><li>This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will require approximately 10% travel as defined by the business (domestic and/ or international).</li><li>This is a dual posting. The final level & title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered (Clinical Program Leader / Senior Clinical Program Leader): <ul><li>Clinical Program Leader: 1-3 years ofexperience leading complex early phase Oncology clinical programs from the pharma/biotech industry and/or academia; Experience with the interpretation of preclinical data in oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology)</li><li>Senior Clinical Program Leader: 3-5+ years ofexperience leading complex early phase Oncology clinical programs from the pharma/biotech industry and/or academia; Experience with the interpretation of preclinical data in oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology)</li></ul></li><li>MD or DO degree and additional laboratory-based training are required; Board certification (or equivalent expertise) in an Oncology sub-specialty </li><li>Working knowledge of the application of pharmacokinetic / pharmacodynamic (PK/PD) and biostatistics to clinical development and clinical trials</li><li>Proven ability to analyze and interpret efficacy and safety data relating to oncology; Knowledge of Good Clinical Practices (GCP) and world-wide regulatory requirements relating to clinical trials and oncology</li><li>Excellent medical/scientific writing and oral communication / presentation skills</li><li>Proven ability to manage and develop a team; Used to working successfully across more than one indication; Excellent teamwork in multidisciplinary settings; Creative and independent leader; Innovative and fearless in designing new approaches to PoC studies and in critical thinking; Looks beyond what is evident and visible</li><li>Inspires others and strong passion for translational science; Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies</li></ul>Desirable Requirements:<ul><li>Pharma / biotech industry preferred</li><li>PhD</li></ul>The pay range for this position at commencement of employment is expected to be between: $248,500.00 - $461,500.00; however, while salary ranges are effective from 1/1/26 through 12/31/26, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Clinical Program Leader / Senior Clinical Program Leader, Translational Clinical Oncology (Dual Posting)

Summary About the Role At Novartis, we are reimagining medicine to improve and extend people's lives. As a QC Analyst, you will support manufacturing and production by executing quality control testing and ensuring ongoing compliance with established quality systems and cGMP standards. This role plays a key part in maintaining testing readiness, supporting analytical activities, and contributing to continuous improvement within the Quality Control laboratory environment. #LI-Onsite Location: Durham, NC This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. About the Role Key Responsibilities<ul><li>Execute routine and non-routine bioanalytical testing for cGMP release and characterization using techniques including CE-SDS, SDS-PAGE, and CZE, and assist with data review.</li><li>Perform method verifications and method transfers to support project and testing needs.</li><li>Support assay readiness through vendor enrollment, reagent ordering, and consumable management.</li><li>Initiate and maintain required documentation including LIMS entries, SOPs, assay forms, and method transfer records.</li><li>Support laboratory operations including safety, housekeeping, logbook usage, equipment operation and maintenance, and updates to procedures.</li><li>Deliver assigned work with accuracy, attention to detail, and schedule adherence.</li><li>Notify management and initiate quality events (e.g., laboratory investigations) with guidance from senior analysts or management.</li><li>Participate in analytical and instrument troubleshooting activities and special projects as assigned.</li></ul>Essential Requirements<ul><li>Bachelor's degree in a scientific discipline such as Biochemistry, Biology, or a related field required.</li><li>Ability to learn and apply professional concepts, company policies, and procedures to resolve routine issues.</li><li>Strong communication skills and ability to work effectively in a team-based laboratory environment.</li><li>Ability to follow detailed instructions and work within established procedures in a regulated setting.</li></ul>The salary for this position is expected to range between $32.11 and $59.61 per hour. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Quality Control, Analyst

Summary The MES Expert will provide technical expertise in support of all issues linked to electronic batch records (eBRs). MES Expert supporting MES deployment, implementation and continuous improvement in the Manufacturing Units and providing shop floor routine technical support. Location: Morrisville Onsite 1st shift role (Monday through Friday) About the Role Major Accountabilities:<ul><li>Responsible for the manufacturing documentation update following the implementation of electronic batch files</li><li>Provide training for MES users in partnership with the training team</li><li>Ensure follow-up and processing of deviations and Change Control in compliance with deadlines and applicable regulations</li><li>Real time shop floor troubleshooting with the implementation of appropriate immediate corrective actions</li></ul>Expertise / Compliance<ul><li>Subject matter expert for MES / SAP / Historian type of production IT systems</li><li>Support deviation and complaint investigations process using investigation tools and methodology</li><li>Develop on-site expertise (MBR design, PAS-X, OSI-PI, interface with SAP and Trackwise)</li><li>Master PAS X and OSI PI systems</li><li>SPOC for major trouble shooting, CAPA execution, change controls management and follow-up for production IT systems</li><li>Prepare, support and follow-up of Health authority and internal inspections</li></ul>Continuous improvement<ul><li>Continually seek to improve the efficiency of its work and simplify processes</li><li>Contribute to continuous improvement by making proposals and participating in the implementation of tangible and effective actions.</li></ul>The salary for this position is expected to range between $81,200 and $150,800 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Minimum Requirements:<ul><li>Bachelor's Degree in Science, Pharmacy, Chemical Engineering or Pharmaceutical Technology or equivalent job experience.</li><li>5+ years of relevant experience in GMP manufacturing process support role.</li><li>Proven experience in MES expert role</li></ul>Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Manufacturing Systems Expert

Summary #LI-Remote-Nashville (KY/TN/WV) Location: Remote- This position focuses on disease states (e.g. prostate cancer, neuroendocrine tumors, & etc.) being treated by Novartis' Radioligand Therapies. The Medical Science Liaison (MSL) role is a field based, customer-facing, non-promotional medical and scientific position. The MSL's key objective is to create impact through advancing clinical practice within the assigned territory that leads to improved patient outcomes. The MSL must demonstrate deep therapeutic expertise, understand territory and market influences, engage scientifically with Healthcare Providers (HCPs) and medical experts, manage, and develop their territory and execute all relevant activities in alignment with the medical strategic and tactical plan - while functioning within the Novartis Code of Conduct, Ethics/Compliance policies and Working Practice documents. The MSL will Inform and shape medical strategy through application of a curious mindset to collect impactful and actionable insights, understanding the potential strategic impact of critical insights. This territory will be responsible for covering KY, TN, and WV. The preferable location for the successful candidate to reside would be in greater Nashville, TN area. Must live within 50 miles of the border of this territory to be considered. Relocation is not available. Role Responsibilities include, but are not limited to &bull; The MSL will leverage scientific expertise and market knowledge to establish and build professional relationships and engage with HCPs (including community physicians, pharmacists, medical experts, nurses, and other healthcare professionals) and other thought leaders in geographical area as aligned with medical strategy. &bull; The primary responsibility of the MSL is to engage with customers - customer engagements may include but are not limited to: emerging data discussions, clinical trial activities, uncovering barriers in patient journey, understanding market dynamics within their territory, exploration of areas of unmet medical need, pipeline discussions, educating on disease state and product, capturing adverse events, and capturing medical insights through all stages of product lifecycle. &bull; Must demonstrate strategic territory vision and ensure appropriate territory identification, mapping, and planning of Medical Engagements (MEs) and Key Accounts as aligned to medical strategy and in collaboration with internal Novartis colleagues. This includes: a. identification of key stakeholders with influence on the patient journey and in the disease space throughout the product development lifecycle to establish strategies for education, engagement, and partnership b. identification of opportunities for partnership with academic centers, centers of excellence, and/or systems of care to drive impact within the assigned territory c. identification of opportunities to involve HCPs or MEs when a specific medical need is identified (e.g., publications, clinical trial participation, etc.) d. identification of opportunities for internal collaboration with other Novartis stakeholders to drive forward therapeutic area, clinical, or product goals as appropriate&bull; Provide clinical trial support for company sponsored trials facilitating relevant medical activities and working cross-functionally with Medical Affairs and Clinical Operations colleagues. &bull; Regularly and effectively collaborates with internal colleagues (e.g., HEOR, access, marketing, commercial, sales) within the assigned therapeutic area and territory to advance clinical practice while maintaining customer centricity and a One Novartis approach in accordance with Novartis compliance standards. &bull; Maintain in-depth knowledge of assigned therapeutic area and Novartis compounds to serve as a medical resource to customers and internal colleagues (in accordance with Working Practice Documents). &bull; Maintain in-depth knowledge of internal policies and external regulations (e.g., field medical Working Practice Document (WPD), travel policy, expense policy, state and local laws, institutional policies) and how they affect day-to-day responsibilities. &bull; Execute all administrative responsibilities and training (e.g., Veeva CRM, voicemail, e-mail, expense reports, compliance modules, etc.) in a timely manner, including profiling of core customers and ensuring up-to-date information in the CRM. &bull; Champion emerging responsibilities as strategic priorities and territory needs evolve &bull; Proactively drive personal and professional development. About the Role MSL, Manager - level: Education: Graduate degree in science or healthcare required; doctoral degree preferred (MD, PhD or PharmD) Experience: &bull; 0-3 years of experience in a Field Medical position within the pharmaceutical industry or as an MSL is required OR &bull; 3-5 years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting preferred. Previous experience in assigned or related therapeutic area is preferred. &bull; Strong clinical knowledge including pharmacotherapy, treatment guidelines, clinical research processes, medical expert engagement strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is required. MSL, Associate Director - level: Education: Graduate degree in science or healthcare required; doctoral degree preferred (MD, PhD or PharmD) Experience: &bull; Minimum of 3 years' experience in a Field Medical-based position within the pharmaceutical industry or as an MSL is preferred OR &bull; 5-7 years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting required. Previous experience in assigned or related therapeutic area is preferred. &bull; Strong clinical knowledge including pharmacotherapy, treatment guidelines, clinical research processes, medical expert engagement strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is required. Travel: &bull; Field based, customer-facing position majority of the time with approximately 60-70% travel required to achieve performance and business objectives (face to face, virtual, email, telephone, etc.). Must have a valid driver's license. &bull; Field-Based (Region: covering KY, TN and WV). Candidate must reside within territory, or within a reasonable daily commuting distance of 50 miles from territory border. &bull; The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager NOTE: Above level experience criteria are not an exhaustive list Field roles with a dedicated training period only: The individual hired for this role will be required to successfully complete certain initial training, including home study, in eight (8) or fewer hours per day and forty (40) or fewer hours per week. Field roles with a company car: Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions, if an accommodation can be provided without eliminating the essential function of driving. The pay range for this position at commencement of employment is expected to be between; for Manager: $145,600 - $270,400 and for AD: $160,300 - $297,700 year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. To learn more about the culture, rewards and benefits we offer our people click here . Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Medical Science Liaison (MSL) Onc Prostate Radioligand Therapies KY, TN, and WV Remote

Summary Job Description Summary #LI-Onsite #Novartis #GeneTherapies #MaintenancePlanning #ManufacturingCareers #Biopharmaceuticals #EngineeringJobs #DurhamNCJobs #OnsiteJobs Location: This role is based in Durham, NC, United States. Novartis is unable to offer relocation support: please only apply if accessible. If you are energized by keeping complex manufacturing operations running at their best, this role puts you at the center of impact. As a Senior Specialist Maintenance Planner/Scheduler, you will play a critical role in ensuring the reliability, safety, and performance of a biopharmaceutical production site by strategically planning and scheduling maintenance and calibration activities. You will partner closely with operations, reliability, and technical teams to align maintenance execution with production priorities, strengthen preventive and predictive maintenance programs, and support a culture of continuous improvement. Your expertise will directly contribute to equipment reliability, regulatory compliance, and the uninterrupted delivery of innovative gene therapy medicines to patients who need them most. About the Role Key Responsibilities:<ul><li>Plan and schedule maintenance and calibration activities for all site equipment and instrumentation to support uninterrupted manufacturing operations</li><li>Create, maintain, and update equipment records and detailed maintenance plans aligned with production schedules and operational priorities</li><li>Provide technical support to maintenance resources and reliability maintenance teams to enable effective execution of planned work</li><li>Deploy, sustain, and support site maintenance programs to ensure consistent, compliant, and reliable equipment performance</li><li>Coordinate maintenance activities to ensure work is thoroughly planned, scoped, estimated, staffed, and executed according to schedule</li><li>Partner closely with production scheduling, operations, and contracted services to align maintenance execution with site and business objectives</li><li>Analyze work orders by urgency, complexity, skill requirements, location, and available manpower to optimize execution flow</li><li>Issue and sequence work orders to technicians or work teams to support efficient use of internal maintenance resources</li><li>Coordinate and direct external subcontractors to support maintenance activities and special project work</li><li>Prepare and deliver maintenance performance metrics and statistical reports demonstrating productive workforce utilization</li></ul>Essential Requirements:<ul><li>Bachelor's degree in a relevant field with a minimum of 5 years' experience in a pharmaceutical manufacturing environment, or 9 years of relevant experience in lieu of a degree</li><li>Broad exposure to multiple technical disciplines, including power transmission, lubrication technology, and electrical and electronic control systems</li><li>Maintenance experience supporting biopharmaceutical processing equipment such as bioreactors, filtration systems, fillers, and clean room air systems</li><li>Demonstrated working knowledge of computerized maintenance management systems and maintenance materials management functionality</li><li>Experience developing and maintaining preventive and predictive maintenance plans for manufacturing equipment</li><li>Working knowledge of reliability centered maintenance techniques and their application to manufacturing equipment</li><li>Ability to perform in-depth root cause failure analysis and apply findings to improve equipment performance</li><li>Proficiency with Microsoft Office tools, including Word, Excel, PowerPoint, and Outlook, and other applicable computer software</li></ul>Desirable Requirements:<ul><li>SAP experience strongly preferred.</li></ul>Novartis Compensation: The salary for this position is expected to range between $81,200 and $150,800 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here. Company will not sponsor visas for this position. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Sr. Spec. Maintenance Planner Scheduler

Summary The Specialist, Supplier Quality Assurance, contributes to our SQA operations as we continue to develop and maintain supplier quality standards to ensure products are manufactured to relevant patient safety and product quality standards in line with business requirements. About the Role Location: <ul><li>This position will be located in Durham, NC and is a Hybrid role; 3 days a week on-site and 2 days a week working remotely.</li><li>Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.</li></ul>Key Responsibilities:<ul><li>Supports the Supplier Quality function responsible for delivering all aspects of the Supplier Quality Assurance.</li><li>Plans, manages and supports supplier audits.</li><li>Supports Supplier Quality core processes; supplier and material qualification for new and existing suppliers, quality agreements, quality risk assessments, supplier maintenance/periodic assessments, supplier monitoring, SPEC creation and revision, supplier complaints, and supplier change notifications.</li><li>Approves and maintains supplier and material data in the appropriate electronic systems (quality and inventory management).</li><li>Addresses supplier quality related issues and facilitates the escalation of unresolved supplier quality issues within assigned projects and suppliers.</li><li>Addresses supplier quality related issues and facilitates the escalation of unresolved supplier quality issues within assigned projects and suppliers.</li><li>Supports the communication, to all levels within the organization, on quality related topics.</li><li>Identifies nonconforming events, facilitates, supports, reviews and approves supplier complaints, performs root cause analyses, and identifies solutions with cross-functional teams.</li><li>Supports resolution and closure of Supplier Quality related corrective and preventive actions.</li><li>May assist with the collaboration with the Global Strategic Sourcing team on new supplier introduction and supply chain initiatives.</li><li>Monitors and regularly reports supplier product quality and performance to appropriate QA Leadership and Business Partners.</li><li>Other related duties as assigned.</li></ul>Essential Requirements:<ul><li>Bachelor's Degree in scientific discipline with 5 years' experience in Biotech/Pharmaceutical industry or 4 years' experience in Biotech/Pharmaceutical industry, with at least 2 years within Novartis Gene Therapies.</li><li>Understanding of common biologics and sterile chemical materials manufacturing processes is a plus.</li><li>Hands on knowledge of quality management and business systems for managing suppliers and materials.</li><li>Basic knowledge of GMP (US, EU and APAC) as well as ISO standards with regards to material and service providers.</li><li>Ability to demonstrate high attention to detail, multi-tasking, and organization ability.</li><li>Ability to work in a diverse and dynamic environment.</li><li>Good communication and interpersonal skills.</li><li>Proficiency in and knowledge of MS Office tools, quality management systems (e.g. Supplier Record and Audits), and Document Management systems</li></ul>Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $89,600 and $166,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. #LI-Onsite Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Specialist, Supplier Quality

Summary Internal Title: Senior Principal Scientist or Associate Director #LI-Hybrid Location: Cambridge, MA USA In this key role you will provide pathology subject matter expertise across drug discovery and development programs throughout the nonclinical and clinical development lifecycle, and/or contributes to department aligned technology development. You will also apply deep scientific judgment to assess the impact, limitations, and value of pathology data to advance projects, inform human risk assessment, and support Novartis portfolio strategy. You will have the opportunity to collaborate broadly across project teams, therapeutic areas, modalities, and external partners while maintaining compliance with Novartis policies, SOPs, GxP, One Quality, and health and safety requirements. About the Role Key Responsibilities:<ul><li>Generate, evaluate, and interpret GLP and non-GLP pathology data for assigned studies, including determination of adversity where appropriate. </li><li>Conduct and/or support postmortem phases of toxicology studies, including pathology peer and scientific review. </li><li>Contribute to integrated nonclinical data analyses, interpretation, human risk assessment, and high quality reporting. </li><li>Support regulatory submissions through preparation and review of pathology related documentation. </li><li>Serve as a pathology contributor or early project team representative for preclinical safety. </li><li>Participate in nonclinical study design, protocol writing, and review. </li><li>Monitor and review pathology procedures and data generated by CROs and external partners. </li><li>Provide scientific and technical interpretation using expertise in clinical pathology, histopathology, histochemistry, morphology, image analysis, transcriptomics, electron microscopy, and related techniques. </li><li>Identify and contribute to novel projects or emerging scientific/technical areas aligned with departmental strategy. </li><li>Maintain current knowledge of scientific advances, technologies, and methodologies. </li><li>Collaborate across therapeutic areas and modalities; identify key connection points to enable project progression. </li></ul>Essential Requirements:<ul><li>Education: DVM (or equivalent, e.g., BVSc) </li><li>Graduate training in pathology</li><li>Preferred candidate will also have a PhD in a relevant biological or toxicologic field and 2 plus years of experience in toxicologic pathology; 5 plus years to be considered at the Associate Director level</li><li>Pathology board certification (e.g., DACVP, ECVP, FRCPath) </li></ul>To be considered at the Associate Director level you will also have:<ul><li>Demonstrated team leadership </li><li>Ability to supervise direct and develop others </li><li>Experience leading programs, platforms, or initiatives </li></ul>This is a dual posting. The final level & title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered. The salary for this position is expected to range between: Senior Principal Scientist I: $176,400 and $327,600 per year. Associate Director: $185,500 and $344,500 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here . Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Portfolio Pathologist (Anatomic)

Summary Internal Title: Director #LI-Hybrid Location: Cambridge, MA USA or Basel, Switzerland As a Cardiovascular and Metabolism (CVM) Therapeutic Area Biomarker Lead (TABL) (Director) you will lead the CVM disease area biomarker matrix team and be responsible for the development and implementation of fit for purpose" biomarker strategies and providing an effective interface for transitioning projects from early to later stage clinical development. You will be a core member of CVM clinical project teams, engaged in Translational Data Science teams, and provide therapeutic area line function review for clinical protocols. As a TABL you will lead efforts to identify, develop, and drive disease, mechanistic and compound biology that serves the clinical and precision medicine approaches for the multi-indication CVM portfolio that focuses on heart failure, atherosclerosis, obesity and atrial fibrillation indications. About the Role Key Responsibilities: &bull; Delivering clinical project and disease biomarker strategies and plans across the early through late phase within the Cardiovascular and Metabolism portfolio and support relevant mature assets in the late phase portfolio &bull; Leading a dedicated matrixed group of Subject Matter Experts and project team representatives as well as key program stakeholders, to together develop biomarkers strategies for disease and/or assets across the Research-Development-Commercial continuum &bull; Representing Biomarker Development on Cardiovascular and Metabolism early and late Disease Area Decision Boards to identify, develop, and drive cardiovascular and metabolic disease and compound mechanistic biology, and precision medicine approaches for the portfolio &bull; Leading strategic translational data working groups centered on integrating and analyzing large-scale patient muti-modal data sets (omics, imaging, digital, etc.) to identify new indications, endpoints, and responsive patient subpopulations &bull; Representing BMD line functions in Therapeutic Area Line Function committees for clinical protocol development and operational milestone reviews &bull; Leading biomarker strategies and drive plans at the clinical team level as a Biomarker Strategy Lead &bull; Lead and/or contribute to BMD/TM/BR wide initiatives e.g. genetics, inflammation, imaging depending on background and expertise &bull; Stay up to date on clinical, disease, biology and scientific literature and competitor data for their respective disease areas &bull; Implementing strategies in close collaboration with the BMD global organization which includes over 150 associates with expertise in all aspects of biomarker science i.e. genetics, genomics, molecular and cellular, digital devices, imaging and data sciences &bull; Design and present the RDC biomarker strategy for transitioning and mature assets for late phase within their key pillar and ensuring study level alignment across the portfolio segment of focus Essential Requirements: &bull; MD, MD/PhD, or PhD degree required, plus additional PhD/postdoc or equivalent level research &bull; Deep understanding of cardiovascular and metabolic disease epidemiology with particular emphasis on Atherosclerotic Cardiovascular Disease (ASCVD) that can be applied to questions of diagnosis, biomarker development and treatment monitoring strongly preferred &bull; Scientific excellence supported by recognized high quality publications; clinical and/or biological expertise in cardiovascular and metabolic diseases (Board certified or similar level preferred) with impact in ASCVD literature &bull; 5 plus years of independent leadership experience and external leadership/partnership in consortia and/or health authority initiatives &bull; Proven success in leading and partnering in multidisciplinary matrix teams across Pharma/biotech (clinical research thru healthcare applications), academic institutions, or commercial business functions including a mature biomarker strategy to support registration and/or launch &bull; Demonstrated ability to own an entire section of the portfolio as well as the phase package; Well-developed interpersonal skills with good presence and ability to influence and negotiate with senior leadership; experienced presenter and communicator &bull; Significant relevant experience after your MD/PhD/postdoc including quantitative expertise in biostatistics, bioinformatics, computer biology, statistical genetics, clinical imaging, machine learning, or data science; interpreting and publishing studies consisting of omics" data e.g. genetics, genomics, proteomics; closely partnering with/leading data scientists &bull; Fluent in oral and written English; other languages e.g. German, French, Italian useful but not required The salary for this position is expected to range between $185,500 and $344,500 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here . Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Therapeutic Area Biomarker Lead/Biomarker Strategy - Cardiovascular and Metabolism

Summary The Process Expert will provide front line support for all issues related to the manufacturing process, continuously improving in quality and efficiency, and in compliance to cGMPs, SOPs and applicable guidelines. Location: Morrisville Onsite 1st shift (Monday through Friday) About the Role Major accountabilities: Shop Floor Support:<ul><li>Provide front line technical and procedural support to manufacturing, working with the cell processing team, focusing on manufacturing each batch safely, on time, in compliance with the batch record and quality requirements.</li><li>Provides latest information regarding best practices, investigation findings, CAPAs, MST/TRD experiences to manufacturing SMEs.</li><li>Perform data analysis and identifies potential process shifts/trends and escalate as necessary.</li></ul>Deviations, Investigations, and CAPAs:<ul><li>Author investigations for product and non-product deviations.</li><li>Conduct manufacturing investigations for Out Of Expectation (OOE), Out Of Specification (OOS), Out of Tolerance (OOT) results.</li><li>Work cross-functionally to assess deviation impact and identify root causes.</li><li>Work with Scheduling and QA to ensure that batches of are released on time through the closure of robust investigations and impact/risk assessments.</li><li>Use process knowledge and root cause investigation tools to analyze data and to identify and root causes of product and process failures.</li><li>Initiate CAPAs and CAPA effectiveness checks to eliminate/mitigate deviations.</li><li>Support the process of escalation of deviations when appropriate according to escalation guidelines. Present escalation events and provide deviations details clearly and on-time (root cause and CAPAs).</li></ul>Business Process & Improvements:<ul><li>Identifies opportunities for process, operational, and quality improvements in conjunction with Manufacturing Team (PU) and Operational Excellence Team (OpEx).</li><li>Execute process technical batches to generate sufficient process knowledge by thoroughly testing critical variables.</li><li>Evaluates manufacturing pre-production technical planning, review of technical data of incoming apheresis materials, to ensure timely and required batch pathway processing by the manufacturing team.</li><li>Provide timely updates to management on status of manufacturing performance. Escalate potential performance issues to 3rd parties.</li></ul>Technology Transfer:<ul><li>Provide timely support for process technology transfer activities from clients/3rd parties.</li></ul>Training:<ul><li>Develop and provide training (as immediate response to unexpected events, for technical document execution, and new products/processes) to the Cell Processing team, as required.</li><li>Owns the Training Curriculum for this Job Profile and provides the necessary training and support to new associates joining the Process Expert position.</li><li>Coach new investigators as part of the Investigator Certification Program.</li></ul>Audit Support:<ul><li>Maintain their processes at inspection readiness level and to provide the necessary support in any internal or external audit.</li><li>Authorities' inspections</li></ul>The salary for this position is expected to range between $81,200 and $150,800 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Minimum Requirements: <ul><li>Bachelor's degree in Science, Engineering or Biology or related field or relevant experience in lieu of a degree.</li><li>2+ years of relevant experience in a GMP environment is required with degree; 7+ years of relevant experience in lieu of a degree.</li><li>Previous GxP experience is required.</li><li>Excellent communication and collaboration skills.</li></ul>Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Process Expert

Summary At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Manufacturing professionals to help us reach our ambitious goals. The Engineering Specialist will execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives. Responsible for execution of maintenance and calibration activities and commissioning activities for projects at site level. Location: Onsite About the Role Major accountabilities: &bull; Adhere to Novartis Quality Policies and procedures as they pertain to the position to ensure that all products are safe, pure, effective and of the highest quality. &bull; Perform a wide range of maintenance repair activities on production equipment, lab equipment and building management systems. &bull; Provide guidance and leadership to team members. &bull; Assist in troubleshooting and repair of process equipment (example: containment isolator systems, filling line equipment and associated utility connections) which may include mechanical, electrical wiring, pneumatics, motors, pumps, vacuum systems, HVAC, control systems, compressed gases, filling line, under little to no supervision. &bull; Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs. &bull; Support 24x7 site-based operations after startup. &bull; Write/revise accurate operational procedures, training documents and maintenance procedures for various production and utility systems. &bull; Provide radiation safety program support, responsible for calibration and functionality of all radiation detection equipment &bull; Completes Equipment Work Order Thoroughly, and Accurately and Documents them in the System &bull; Supply information and technical data for securing spare parts. &bull; Provide responsive customer support with emphasis on customer satisfaction. &bull; Perform startup and commissioning activities as required. &bull; Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs &bull; Perform preventative and corrective maintenance on manufacturing process related equipment within a cleanroom environment. &bull; Complete and provide accurate documentation, as required in cGMP operations. &bull; Oversee work and provide training of less experienced maintenance technicians and/or new technicians. &bull; Other related duties as assigned. &bull; Use of CMMS system for documentation of relevant work. The salary for this position is expected to range between $85,400 and $158,600 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Minimum Requirements: &bull; High School diploma or equivalent is required; bachelor's degree is preferred. &bull; 3+ years of relevant hands-on plant maintenance experience in a regulated GMP environment is required. &bull; Previous supervisory, team/project lead experience is preferred. &bull; Previous aseptic fill/finish and/or radio pharmacy experience is preferred. &bull; Previous pharmaceutical or medical device experience is preferred. &bull; Completed training in radioactive or hazardous materials environment is preferred. &bull; Must be able to adhere to all applicable procedures, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.) &bull; Experience working in a team environment, with excellent communication and organizational skills. &bull; Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS) or similar system. &bull; Ability to climb ladders and lift up to 50 lbs. &bull; Wear and work in protective clothing, including respiratory protection, confined space entry and clean room environments. &bull; Must be flexible to work nights, weekends, and holidays as required. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Engineering Specialist

Summary Internal Title: Director #LI-Hybrid Location: Cambridge, MA USA In this key role you will provide global, end to end nonclinical safety leadership across multiple therapeutic areas and modalities, ensuring scientifically robust, fit for purpose, and regulatory compliant safety strategies that enable successful clinical trial initiation and support registration. You will serve as the primary Preclinical Safety (PCS) authority on cross functional R&D teams and in interactions with global Health Authorities. You will be a critical enabler of portfolio progression, providing authoritative nonclinical safety leadership, regulatory credibility with Health Authorities, and strategic integration across therapeutic areas and modalities. Success is defined by timely clinical entry, robust regulatory outcomes, and strong cross functional trust in PCS scientific leadership. About the Role Key Responsibilities: &bull; Lead PCS Target Teams to design, integrate, interpret, and apply nonclinical safety assessment programs, including impact on development strategy and timelines. &bull; Represent Preclinical Safety on cross functional R&D project teams, ensuring scientifically sound and globally compliant nonclinical safety packages. &bull; Define and implement fit for purpose, modality appropriate nonclinical programs in collaboration with PCS and external line functions. &bull; Lead global Health Authority interactions, including negotiation on safety issues, scientific interpretation, and acceptability of nonclinical packages. &bull; Author nonclinical safety sections of internal and regulatory documents supporting clinical development and market approval (e.g., IND/NDA). &bull; Drive and coordinate communication strategies between PCS and R&D project teams. &bull; Participate in or lead internal and external cross functional initiatives advancing PCS and/or Translational Medicine objectives and current safety topics. &bull; Support evaluation of in licensing and out licensing opportunities, including collaboration with BD&L and integration activities. &bull; Mentor and coach colleagues on drug development strategy and project related scientific decision making. Essential Requirements: &bull; Advanced scientific degree (PhD, MD, DVM, PharmD, or equivalent) in Toxicology, Pharmacology, or related discipline; or DABT; or equivalent industry experience. &bull; 5 plus years experience as a nonclinical safety Project Team member, preferably across multiple development phases up to registration. &bull; 8 or more years experience in nonclinical drug development (e.g., project toxicologist, pharmacologist, study director). &bull; Demonstrated expertise across multiple modalities (e.g., small molecules, biotherapeutics, oligonucleotides) and their safety considerations. &bull; Proven track record of direct interaction with global Health Authorities, including shaping regulatory strategy and submission writing. &bull; Recognized scientific and regulatory expertise in nonclinical safety assessment within a global drug development context. &bull; Demonstrated leadership and influence in complex, matrix managed, international project environments. &bull; Strong problem solving capability in multidisciplinary, project driven settings. Desirable Experience: &bull; Prior experience in the pharmaceutical industry. &bull; Leadership or participation in relevant to drug development or safety assessment. The salary for this position is expected to range between $185,500 and $344,500 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here . Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Director, Nonclinical Safety Assessment Expert (Multiple Therapeutic Areas)

Summary We are seeking a highly motivated, detail-oriented biologist to join our Lead Identification and Optimization (LIDO) teams in our research site in Cambridge (MA, US). You will accelerate drug discovery by producing high quality data on compounds tested in cellular and biochemical profiling assays, working closely with your colleagues in global Discovery Sciences (DSc) and project teams within Biomedical Research (BR) located in Cambridge and Basel. About the Role Internal Job Title: Research Scientist II Position Location: Cambridge, MA, onsite<ul><li>Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. #LI-onsite</li></ul>We are seeking a highly motivated, detail-oriented biologist to join our Lead Identification and Optimization (LIDO) team at our research site in Cambridge, MA. You will accelerate drug discovery by producing high quality data on compounds tested in cellular and biochemical profiling assays, working closely with your colleagues in global Discovery Sciences (DSc) and project teams within Biomedical Research (BR) located in Cambridge and Basel. Key responsibilities:<ul><li>Adapt biochemical and/or cellular profiling assays into robust and standardized assays to support testing of newly synthesized compounds generated by project teams with a focus on fast turnaround times with regards to delivering data.</li><li>Develop, document and maintain SOPs for LIDO process and quality control.</li><li>Proactively identify and implement improvements to enhance lab processes, performance and reliability.</li><li>Coordinate and plan execution of LIDO profiling assays with internal stakeholders.</li></ul>Essential Requirements:<ul><li>BS or MS in Biology, Biochemistry, or equivalent qualification, and 2+ years of related experience. This is not a PhD level position.</li><li>Expertise in either biochemical or cellular assay execution.</li><li>High attention to detail and commitment to operational excellence.</li><li>Strong organizational and time-management skills.</li><li>Ability to work independently and collaboratively within multidisciplinary global teams.</li><li>Flexibility and responsiveness to shifting priorities.</li><li>Excellent written, verbal, and interpersonal communication skills.</li></ul>The salary for this position is expected to range between $81,200 and $150,800 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here . Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Research Scientist, Lead Identification and Optimization (LIDO) Profiler (BS or MS)

Summary #LI-Hybrid Location: Cambridge, MA USA The Associate Director, Portfolio Strategy & Operations, supports the effective strategic management and operational execution of the Therapeutic Area (TA) functions that comprise Translational Medicine Discovery & Profiling (TMDP). Reporting to the TMDP - Strategy & Planning Lead Director, this role contributes to TA strategic planning, business operations, portfolio coordination of key TAs, and delivery of key initiatives that enable the TA(s) and TA Heads to achieve their objectives. The position aligns closely with Functions, cross-functional teams, and internal stakeholders to ensure seamless operations and effective execution of strategic priorities. About the Role Key Responsibilities: &bull; Acts as strategic thought partner for TMDP TA Head(s), reflecting on key topics and trends across therapeutic pillars. Maintain an integrated portfolio view for the assigned TA(s), overseeing study tracking, milestone progression, and identification of risks or shifts requiring alerts &bull; Provides comprehensive TA portfolio assessments in TM relevant projects including analysis of scale, speed, efficiency metrics to guide portfolio alignment with strategic objectives and delivers value efficiently &bull; Continuously engage in portfolio analysis and strategy topics to bring TMDP TA strategic prospective into various portfolio reviews and prioritization across TM and different management/decision boards &bull; For the responsible TA(s), lead goals tracking, portfolio analysis, bring insights, and support effective alignments among project management, DA Portfolio Strategy Development (PSD), TA Leadership (TAL)and Disease Area Decision Board (DADBs) &bull; Supports TMDP TA Head(s) for coordinating essential internal processes and priority initiatives such as TA objective planning, internal TA meetings including cross-TA meetings, FTF meetings with partner groups, external reviews and collaborations, headcount planning, resource forecasting, and performance tracking of responsible TA(s) &bull; Support TA Heads in internal communication across strategic meetings, presentations and updates. Coordination of TA-level team meetings, including agenda setting, material preparation, facilitation and action follow-up. &bull; Lead operational excellence, process simplification, automation opportunities, AI enabled improvements, and coordination of cross-functional initiatives to address enterprise level challenges &bull; Coordinates a strategy for KOL interactions, including oversight of logistics &bull; Contributes to organizational development activities, including change management, capability initiatives and trainings Essential Requirements: &bull; Bachelor's degree required; advanced degree MBA, MSc, PhD strongly preferred in life sciences, or related field &bull; Minimum 6 years of experience in pharmaceutical, biotech, or related industry &bull; Prior experience with pharma portfolio analysis, portfolio management and strategy or portfolio operations &bull; Experience within early development, clinical development, business operations or R&D operations preferred &bull; Strong analytical and problem-solving capabilities &bull; Strong interpersonal skills and ability to collaborate across teams and levels &bull; Ability to synthesize complex information and communicate clearly &bull; Excellent organizational skills and ability to manage multiple priorities Desirable Requirements: &bull; Ability to leverage technologies and AI &bull; Proficiency with business tools (Excel, PowerPoint, Power BI, AI agents, etc.) &bull; Ability to working in global matrixed organizations preferred The salary for this position is expected to range between $132,300 and $245,700 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.