Analytical Development Group Leader

4 days ago


Cambridge, Massachusetts, United States Adaptimmune Full time
Job Summary

We are seeking an experienced Analytical Development Group Leader to lead our team in the development and optimization of analytical assays for clinical-stage T cell therapy products. As a subject matter expert, you will provide strategic direction and tactical scientific assistance to a team of scientists and associates, ensuring the successful testing of manufactured T cell drug products for clinical trials.

Key Responsibilities
  • Lead the development, optimization, qualification, and tech transfer of analytical assays for clinical-stage T cell therapy products.
  • Manage, train, and mentor a diverse team of scientists and associates, providing career development opportunities and ensuring effective communication and project oversight.
  • Write protocols, reports, risk assessments, and other related procedures for regulatory support, technology transfer, and internal use.
  • Collaborate with cross-functional teams across CMC, Quality, Regulatory, Translational, and Research to ensure the successful implementation of analytical methods and release assays.
  • Author and review CMC content for IND submissions, amendments, and BLA filings.
Qualifications and Experience
  • Ph.D., M.Sc., or B.Sc. in cell and/or molecular biology, engineering, or a relevant discipline with a minimum of 6 years (Ph.D.), 8 years (M.S.), or 10 years (B.S.) of industry experience.
  • Experience in working in cross-functional teams, familiar with CMC team matrix environments and internal/external collaborations to support successful manufacturing of T cell drug products for clinical trials.
  • Excellent track record of people management and career development support.
  • Experience with analytical assay development, including bioassays, qPCR/ddPCR, and flow cytometry.
  • Experience with method qualification and/or validation, with analytical comparability a plus.
  • Strong technical skills with industry experience in writing regulatory documents, including CMC sections of INDs and BLA.
  • Experience in transferring analytical assays into cGMP facilities and serving as an SME with external CRO/CDMOs.
  • Outstanding critical thinking, collaborative mindset, and organizational skills, leadership, and attention to detail.
  • Comfortable in a fast-paced environment.


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