Novartis
Senior Expert Science & Technology, Potency, Analytical Development
Novartis, East Hanover, New Jersey, us, 07936
Overview
Senior Expert Science & Technology, Potency, Analytical Development. This position will be located at East Hanover, NJ and will not have the ability to be located remotely. Key Responsibilities
Independently design and develop complex cellular characterization and potency assays for cell therapy products. Lead, own, and drive potency method development, optimization, qualification, transfer, and implementation activities, along with the relevant project-specific sub-teams. Actively keep abreast with the latest advances in next-generation analytical technologies for cell therapies. Record and maintain meticulous records in electronic laboratory notebook in compliance with GLP/GMP standards. Continually identify areas for improvement with tangible solutions and implementation approaches. Knowledge of appropriate GMP/GLP quality systems. Support tracking and trending systems, and programs, which assist in the testing, evaluation and monitoring of quality and efficiency. Author and review technical and regulatory documents to ensure completeness, accuracy, consistency and clarity. Requirements
A Bachelor’s, Master’s, or Ph.D. in biology, chemistry, biochemistry, immunology or other related science. Minimum of 8+ years (Bachelor’s), 5+ years (MS) or 3+ years (Ph.D.) of industry experience in assay development in biologics potency or in cell and gene therapy field analytical development. Understanding of the scientific principles underpinning cellular-based analytical methods including ELISA and cell-based assays. Expertise with aseptic technique and mammalian cell culture including suspension cells. Ability to present complex data and communicate clearly with a variety of cross-functional teams. Detail-oriented with expertise in problem solving and solid decision-making abilities. Established ability to work in a regulated environment. Good presentation skills and scientific/technical writing skills. Desired Requirements
Human T-cell culture experience is desirable. Experience writing laboratory SOPs and technical instructions is preferred. Direct experience with GMP is a plus. Experience with biophysical techniques (eg. HPLC, SPR, LC-MS) is a plus. Late stage experience preferred. Compensation & Benefits
The pay range for this position at commencement of employment is expected to be between $114,100-$211,9000. However, salary ranges are effective from 1/1/25 through 12/31/25, and fluctuations in the job market may necessitate adjustments to pay ranges during this period. Final pay determinations will depend on various factors including geographical location, experience level, knowledge, skills, and abilities. The total compensation package may also include other elements, such as 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). Details of participation in these benefit plans will be provided if an offer is made. If hired, the employee will be in an at-will position and the Company reserves the right to modify base salary or other discretionary compensation at any time, including for reasons related to individual or company performance and market factors. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If 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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Senior Expert Science & Technology, Potency, Analytical Development. This position will be located at East Hanover, NJ and will not have the ability to be located remotely. Key Responsibilities
Independently design and develop complex cellular characterization and potency assays for cell therapy products. Lead, own, and drive potency method development, optimization, qualification, transfer, and implementation activities, along with the relevant project-specific sub-teams. Actively keep abreast with the latest advances in next-generation analytical technologies for cell therapies. Record and maintain meticulous records in electronic laboratory notebook in compliance with GLP/GMP standards. Continually identify areas for improvement with tangible solutions and implementation approaches. Knowledge of appropriate GMP/GLP quality systems. Support tracking and trending systems, and programs, which assist in the testing, evaluation and monitoring of quality and efficiency. Author and review technical and regulatory documents to ensure completeness, accuracy, consistency and clarity. Requirements
A Bachelor’s, Master’s, or Ph.D. in biology, chemistry, biochemistry, immunology or other related science. Minimum of 8+ years (Bachelor’s), 5+ years (MS) or 3+ years (Ph.D.) of industry experience in assay development in biologics potency or in cell and gene therapy field analytical development. Understanding of the scientific principles underpinning cellular-based analytical methods including ELISA and cell-based assays. Expertise with aseptic technique and mammalian cell culture including suspension cells. Ability to present complex data and communicate clearly with a variety of cross-functional teams. Detail-oriented with expertise in problem solving and solid decision-making abilities. Established ability to work in a regulated environment. Good presentation skills and scientific/technical writing skills. Desired Requirements
Human T-cell culture experience is desirable. Experience writing laboratory SOPs and technical instructions is preferred. Direct experience with GMP is a plus. Experience with biophysical techniques (eg. HPLC, SPR, LC-MS) is a plus. Late stage experience preferred. Compensation & Benefits
The pay range for this position at commencement of employment is expected to be between $114,100-$211,9000. However, salary ranges are effective from 1/1/25 through 12/31/25, and fluctuations in the job market may necessitate adjustments to pay ranges during this period. Final pay determinations will depend on various factors including geographical location, experience level, knowledge, skills, and abilities. The total compensation package may also include other elements, such as 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). Details of participation in these benefit plans will be provided if an offer is made. If hired, the employee will be in an at-will position and the Company reserves the right to modify base salary or other discretionary compensation at any time, including for reasons related to individual or company performance and market factors. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If 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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