Senior Scientist, Gene Therapy Potency – CMC Analytical Development
About The Position
The Senior Scientist will serve as the analytical potency SME within CMC Analytical Development, supporting biologics programs including AAV-based gene therapies, monoclonal antibodies, and antibody conjugates. This role leads the development, qualification/validation, transfer, and lifecycle management of potency assays used to monitor critical quality attributes (CQAs) of drug substance and drug product. The position defines and executes potency strategy, designs robust cell-based functional assays, and ensures regulatory-compliant data generation across all development stages in alignment with cGMP and global regulatory requirements.
Requirements
- PhD in Molecular Biology, Cell Biology, Virology, Biochemistry, or related field with some industry experience; OR MS with 3+ years; OR BS with 5+ years
- Demonstrated expertise in potency assay development for gene therapy products, especially AAV or lentiviral vectors
- Strong understanding of gene therapy MOA and translation into biologically relevant potency assays
- Hands-on experience with: Cell-based potency assays (reporter, transduction/infectivity, functional protein expression)
- Molecular assays (qPCR, ddPCR, RT-qPCR)
- Flow cytometry–based assays
- Immunoassays (ELISA, MSD)
- Experience with assay qualification/validation (ICH Q2), lifecycle management, and cGMP compliance
- Experience with analytical method transfer and CDMO collaboration
- Familiarity with FDA, EMA, and ICH regulatory expectations for gene therapy potency strategy
- Strong statistical analysis, critical thinking, and communication skills
- Effective contributor within cross-functional CMC teams
Responsibilities
- Act as potency SME on cross-functional CMC teams; own analytical deliverables, timelines, and risk mitigation
- Establish potency strategy aligned with mechanism of action and regulatory expectations, linking CQAs to clinical relevance
- Develop, optimize, qualify, validate, and manage lifecycle of potency assays, particularly for viral vector–based gene therapies
- Design and execute cell-based functional assays assessing transgene expression, biological activity, infectivity/transduction, and MOA-relevant endpoints
- Develop molecular and biochemical assays (qPCR/ddPCR, RT-qPCR, ELISA, reporter assays, flow cytometry, Western blot) as appropriate
- Perform statistical analysis and data interpretation; author validation protocols, technical reports, and CMC regulatory documentation
- Lead analytical method transfer to QC and CDMOs, including training and method comparability assessments
- Support IND/IMPD and BLA/MAA submissions and respond to health authority inquiries
- Ensure compliance with cGMP, ICH guidelines, and internal quality systems
- Mentor junior scientists and promote scientific rigor and collaboration
Benefits
- retirement savings plan (with company match)
- paid vacation, holiday and personal days
- paid caregiver/parental and medical leave
- health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
