- Somerville, Massachusetts, United States
- On-site
- Full-time · Manager
- $150K–$175K per year
- 5–8 years
The Senior Manager, Analytical Sciences will provide scientific and technical leadership for analytical activities supporting our gene therapy product portfolio across internal and external development and testing networks.
Compensation
$150,000—$175,000 USD
Responsibilities
- Serve as the analytical lead for external testing laboratories, providing scientific oversight of analytical execution, method performance, lifecycle management activities, and continuous improvement initiatives.
- Develop and maintain strong working relationships with CDMO, CRO, and contract testing partners to ensure consistent method execution and analytical performance.
- Lead governance activities related to analytical methods including transfers, validations, investigations, method revisions, trend monitoring, and change assessments.
- Evaluate assay suitability throughout the product lifecycle and identify opportunities for optimization, modernization, or platform replacement.
- Support analytical strategy and long-term control strategy development for clinical and commercial programs.
Requirements
- Ph.D. in Biochemistry, Molecular Biology, Analytical Chemistry, or a related scientific discipline
- M.S.
- Nice to have: Experience managing analytical activities across multiple external testing organizations
- Nice to have: Hands-on experience with CD34+ cell lineages
- Nice to have: Viral vector characterization