Senior Expert Science & Technology, Potency, Analytical Development
Novartis
Full-time
On-site
East Hanover, NJ
Clinical Research and Development
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Role Summary
Senior Expert Science & Technology, Potency, Analytical Development located in East Hanover, NJ. Develop, optimize, and implement novel analytical methodologies for CAR-T cell therapy products. Own and drive technical development projects for release and characterization of cell therapy product potency, and contribute to cross-functional activities including process and product characterization and method implementation in routine testing labs.
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 relevant project-specific sub-teams; stay current with next-generation analytical technologies for cell therapies.
- Record and maintain meticulous records in electronic laboratory notebook in compliance with GLP/GMP standards.
- Identify areas for improvement with tangible solutions and implementation approaches.
- Maintain knowledge of GMP/GLP quality systems.
- Support tracking and trending systems and programs to assist in testing, evaluation, and monitoring of quality and efficiency.
- Author and review technical and regulatory documents to ensure completeness, accuracy, consistency and clarity.
Qualifications
- Required: Bachelor’s, Master’s, or Ph.D. in biology, chemistry, biochemistry, immunology, or related science.
- Required: 8+ years (Bachelor’s), 5+ years (MS), or 3+ years (Ph.D.) of industry experience in assay development in biologics potency or cell and gene therapy analytical development.
- Required: Understanding of principles underpinning cellular-based analytical methods including ELISA and cell-based assays.
- Required: Expertise with aseptic technique and mammalian cell culture including suspension cells.
- Required: Ability to present complex data and communicate clearly with cross-functional teams.
- Required: Detail-oriented with strong problem-solving and decision-making abilities.
- Required: Ability to work in a regulated environment; strong presentation and scientific/technical writing skills.
Skills
- Cellular characterization and potency assay development
- GMP/GLP quality systems
- Data presentation and scientific writing
- Cross-functional collaboration
Education
- Bachelor’s, Master’s, or Ph.D. in biology, chemistry, biochemistry, immunology, or related field.
Additional Requirements
- Desirable: Human T-cell culture experience.
- Desirable: Experience writing laboratory SOPs and technical instructions.
- Desirable: Direct experience with GMP.
- Desirable: Experience with biophysical techniques (e.g., HPLC, SPR, LC-MS).
- Desirable: Late-stage experience.