Principal Scientist, Analytical Science and Technology; ASAT), Cell Therapy
Listed on 2026-07-08
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Research/Development
Biotech Research, Research Scientist, Regulatory Compliance Specialist, Pharmaceutical Science/ Research
Position Summary
The Principal Scientist is a senior subject‑matter expert responsible for leading method optimization, transfer, and validation for the Cell Therapy analytical portfolio. The role requires conceptualizing and directing complex projects, providing strategic scientific and technical input, troubleshooting, and mentoring while maintaining hands‑on laboratory involvement.
Duties / Responsibilities- Lead technical investigations, method optimization, remediation, transfer, and validation in compliance with regulatory requirements.
- Independently develop, write, and execute methods, protocols, reports, and other documentation aligned with regulatory and corporate guidelines.
- Conceptualize and lead complex projects, investigations, corrective actions, and continuous improvement initiatives.
- Represent the department on product review boards and regulatory inspections; author relevant analytical sections for regulatory submissions.
- Implement method lifecycle and maintenance programs supporting viral vector and cell therapy drug products.
- Collaborate with development teams on study design, reagent selection, and method optimization initiatives.
- Communicate and collaborate effectively with cross‑functional teams and sites.
- Apply technical knowledge to troubleshoot and solve complex non‑routine issues.
- Perform additional tasks as assigned.
Reports directly to the Senior Director of Analytical Science and Technology (ASAT), and collaborates with cross‑functional and cross‑site teams.
Qualifications- Advanced strategic thinking and problem‑solving skills; strong written communication.
- Ability to work independently in a fast‑paced matrix environment and prioritize multiple projects.
- Excellent hands‑on laboratory skills, including execution and interpretation of complex, high‑impact data.
- Demonstrated mentoring, coaching, and influencing abilities.
- For Molecular Role:
Expertise with lentiviral, AAV vectors, and other gene delivery platforms. - Strong scientific background in Cell Biology or Molecular Biology.
- Capacity to travel as required.
- Bachelor’s or Master’s degree in (bioanalytical) science; advanced degree preferred.
- 10+ years of relevant experience in regulated cellular therapy or gene therapy, or an equivalent combination of education and experience.
- Expert knowledge of bioanalytical and molecular techniques (cell‑based assays, ELISA, qPCR, flow cytometry) and experience with method validation and transfer.
- Experience with cGMP regulations and FDA, EMA, ICH, USP, EP guidelines in the quality control of viral vectors, cell therapies, vaccines, or biological products.
Bristol Myers Squibb is an equal opportunity employer and prohibit discrimination or harassment of any employee or job applicant for any reason, including disability, race, color, religion, sex, national origin, age, or other protected characteristics.
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