Director, Potency Assay Development- Analytical Operations
US - CA - Santa Monica, United States
USD 205K-266K Executive-level Full Time
Tasks
- Define potency assay control strategy using QbD and risk principles
- Drive potency assay development optimization and qualification
- Ensure assay robustness reproducibility and transferability
- Lead method transfer and external collaboration with QC and vendor labs
- Lead potency assay development team
- Manage CMC analytical projects for potency assays
- Oversee method validation verification documentation and SOPs
- Provide potency assay troubleshooting and data interpretation
- Support routine GMP release and stability testing
- Translate ICH guidance into compliant analytical strategies
Perks/Benefits
Skills/Tech-stack
By Design | CAPA | CAR-T | CGMP | Cell therapy | Change Control | Comparability | Control strategy | Cytokine release assays | Cytotoxicity assays | Data Integrity | Digital PCR | Dose response | Dose-response analysis | FCS Express | Flow Cytometry | FlowJo | Gene Therapy | ICH Guidelines | Infectivity assays | Method validation | Method verification | OMIQ | Parallel line analysis | Potency assays | Qualification | Quality by Design | Response analysis | Risk Assessment | Statistical Analysis | System suitability | System trending | Viral Vector
Education
Regions
Countries
States
Cities
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