Cellares
Cell and Gene Therapy
SeniorAnalyticalTransferScientist
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Analytical Transfer Scientist at Cellares. Skills: Method transfer, Analytical methods, Cell and gene therapies. Lead method transfer, validation, optimization. Oversee method transfer to QC labs”
Industry & Context.
Method optimization; Analyze complex bioanalytical data
What They're Looking For.
Must Have
Master's or Ph. D. in Analytical Chemistry, Biochemistry, Molecular Biology, or a related field, 6-14 years of relevant experience in cell and gene therapy, 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
What You'll Do.
Oversee method transfer to QC labs
Execute advanced testing for product characterization
Analyze complex bioanalytical data
Prepare technical reports and regulatory sections
Ensure analytical method compliance
Provide technical support for submissions
Stay informed about analytical technologies
How You'll Work.
Team & Collaboration
Collaborate with Process Development, Manufacturing, Quality Control, and R&D teams; Provide analytical support across product development stages; Experience working in cross-functional teams
Full Job Description
## 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) Oversee the transfer of analytical methods to internal or external Quality Control laboratories, ensuring adherence to GMP and regulatory guidelines Execute advanced testing for product characterization, process development, stability testing, and comparability assessments to align with FDA, EMA, and ICH standards Analyze complex bioanalytical data and prepare technical reports, protocols, and analytical sections for regulatory submissions, including IND, BLA, and MAA filings 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 Stay informed about the latest advancements in analytical technologies and evaluate new tools to enhance the team’s capabilities ## 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 Self-awareness, integrity, authenticity, and
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