Cellares
Senior Analytical Transfer Scientist
Bridgewater, NJ · Senior
Sponsorship not specified$90k-$210kDetected 54 days ago
Data AnalysisCustomer SupportGMPFDA RegulatoryqPCRCRISPRFlow CytometryMolecular BiologyProtein Analysis
About the role
- Cell Shuttles will be deployed in Cellares' Smart Factories around the world to meet total patient demand for cell therapies at global scale.
- Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
- The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey.
Responsibilities
- Lead the method transfer, Validation and optimization (if necessary) of analytical methods for cell and gene therapies, including assays for identity, potency, purity, and safety (e.g., qPCR/ddPCR, flow cytometry, ELISA, cell-based assays, viral vector quantification)
- Ensure all analytical methods comply with cGMP, FDA, EMA, and ICH guidelines, providing technical support during regulatory submissions and inquiries
- Collaborate closely with Process Development, Manufacturing, Quality Control, and R&D teams to provide analytical support across product development stages
Requirements
- Master's or Ph.D. in Analytical Chemistry, Biochemistry, Molecular Biology, or a related field with 6-14 years of relevant experience in cell and gene therapy
- Strong experience with bioanalytical techniques, including qPCR/ddPCR, flow cytometry, ELISA, cell-based potency assays, and viral vector assays (AAV, lentivirus)
- Experience in method development, validation, and transfer under GMP conditions for cell and gene therapy products
- Knowledge of regulatory filing requirements for viral vectors, gene-modified cells, and advanced therapeutic products
- Proficiency in data analysis using software tools like FlowJo, JMP, and GraphPad Prism
- Experience working in cross-functional teams in a fast-paced, regulatory-driven environment
Compensation
- $90k-$210k
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