Associate Expert Science & Technology, Analytical Development, Potency and Flow
Novartis
Role Purpose
- Develop, optimize, and implement novel analytical methodologies for CAR-T cell therapy products.
- Participate in analytical method development, qualification, and method transfer.
- Execute analytical assays to understand/characterize cell therapy product function.
- Interface with Process Development, Quality Control, and Manufacturing Sciences & Technology to meet timelines while maintaining quality and data integrity.
Responsibilities
- Handle cells in culture with strong organizational and scientific technical skills.
- Plan, organize, perform, and document scientific experiments under moderate supervision.
- Perform analytical testing, including flow cytometry and cell-based bioassays (cytokine release, cytolytic activity, proliferation) following SOPs.
- Review and approve data generated by other team members.
- Maintain meticulous records in an electronic laboratory notebook in compliance with Quality standards.
- Identify opportunities for method improvement and optimize analytical methods.
- Drive project timelines and deliverables while meeting internal quality and data integrity requirements.
- Communicate and present complex data within the department and cross-functionally.
- Author and review method-related technical documents for completeness, accuracy, consistency, and clarity.
- Support lab management (inventorying, clinical sample cryopreservation, and sample management).
Requirements
- BA/BS or MS in biology, chemistry, biochemistry, microbiology, or related science; minimum 1 year industry or academia experience.
Preferred/Plus
- Scientific curiosity.
- Understanding of cellular-based analytical methods (including ELISA and cell-based assays).
- Aseptic technique and mammalian cell culture (suspension cells); human T-cell culture is a plus.
- Clear communication with cross-functional teams; detail-oriented problem solving; decision-making.
- Experience working in a regulated environment.
- Presentation and scientific/technical writing skills.
- Experience writing laboratory SOPs/technical instructions (preferred).
- GMP experience (plus).
Compensation/Benefits (as stated)
- Salary expected: $77,000–$143,000 per year.
- Performance-based cash incentive; potential eligibility for annual equity awards.
- Benefits include health/life/disability, 401(k) with company contribution and match, and time off (vacation, personal days, holidays, other leaves).