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Analytical Development Group Leader
2 months ago
We are seeking an experienced Analytical Development Group Leader to join our Process and Analytical Development team at Adaptimmune. As a subject matter expert in analytical assays development, you will lead early-stage and late-stage analytical assays development/optimization and tech transfer of release and characterization testing for clinical stage of T cell Therapy products with a focus on pivotal and commercial readiness.
Key Responsibilities- Lead Analytical Assay Development: Develop, optimize, qualify, and transfer analytical assays to QC team, CRO or CMO partners for clinical stage of T cell Therapy products with a focus on pivotal and commercial readiness.
- Team Leadership: Effectively manage, train, and mentor a diverse team of Scientists and Associates by communicating clearly, assigning responsibilities, providing oversight of projects, and career development opportunities.
- Regulatory Support: Write protocols, reports, risk assessments, and other related procedures for regulatory support, technology transfer, and internal use.
- Cross-Functional Collaboration: Collaborate with cross-functional teams across CMC, Quality, Regulatory, Translational, and Research and interact with contract manufacturing organizations (CMOs) to ensure appropriate release assays implementation and conduct of analytical methods.
- CMC Content Authorship: Author and review CMC content for IND submissions, amendments, and BLA filing.
- Education: Ph.D., M.Sc., or B.Sc. in cell and/or molecular biology, engineering, or relevant discipline with a minimum of 6 years (Ph.D.), 8 years (M.S.), or 10 years (B.S.) of industry experience.
- Experience: Experience in working in cross-functional teams, familiar with CMC team matrix environment and internal/external collaborations to support successful manufacturing of T Cell drug products for clinical trials.
- Leadership and Management: Excellent track record of people management and career development support.
- Technical Skills: Experience with analytical assay development, including bioassays, qPCR/ddPCR, and flow cytometry. Experience with method qualification and/or validation, experience with analytical comparability a plus.
- Regulatory Writing: Strong technical skills with industry experience in writing regulatory documents, including CMC sections of INDs and BLA. Additional experience writing technical protocols, reports, and procedures required.
- Transfer and SME: Experience in transferring analytical assays into cGMP facility and serving as an SME with external CRO/CDMO.
- Soft Skills: Outstanding critical thinking, collaborative mindset, and organizational skills, leadership, and attention to details. Comfortable in a fast-paced environment.
