Sr Scientist, Analytical Sciences

Role: Senior Scientist, Analytical Sciences leading analytical development for gene therapy products.

Responsibilities:

• design, execute, and innovate analytical assays supporting process development, process comparability, and regulatory filings;
• lead transfer of methods to external QC labs;
• troubleshoot assays and support investigations;
• collaborate across CMC teams to prepare technical reports and SOPs.

Requirements:

• Ph.D. in Biochemistry, Molecular Biology, Analytical Chemistry, or related field with 2-5 years (Ph.D.) or 6+ years (M.S.) industry experience;
• hands-on expertise in cell and gene therapy analytical techniques (e.g., flow cytometry, ddPCR/qPCR, potency assays, ELISA);
• proven track record in assay development, tech transfer, troubleshooting, and regulatory documentation;
• excellent communication skills.

HighValue:

• gene therapy, cell and viral vector assays, assay transfer to CDMOs/CROs, process development support, regulatory submissions (IND/BLA).

WorkSetup: onsite in Somerville.