Senior Analytical Development Team Lead
14 hours ago
We are seeking a highly experienced Senior Analytical Development Team Lead to join our Process and Analytical Development group at Adaptimmune. This is an excellent opportunity for career development, working closely with the Process Development team and cross-functional CMC groups.
Key Responsibilities- Lead analytical assay development, optimization, qualification, and tech transfer to QC team, CRO or CMO partners for clinical stage of T cell Therapy products with a focus on pivotal and commercial readiness (30%).
- 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 (30%).
- Write protocols, reports, risk assessments, and other related procedures for regulatory support, technology transfer, and internal use (20%).
- 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 (10%).
- Author and review CMC content for IND submissions, amendments and BLA filing (10%).
To be successful in this role, you will require:
- A Ph.D., M.Sc. or B.Sc. in cell and/or molecular biology, engineering, or relevant discipline with a minimum of 6 years (PhD), 8 years (M.S.) or 10 years (B.S.) of industry 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.
- 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, experience with analytical comparability a plus.
- 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.
- Experience in transferring analytical assays into cGMP facility and serving as an SME with external CRO/CDMO.
- Outstanding critical thinking, collaborative mindset and organizational skills, leadership, and attention to details.
- Comfortable in a fast-paced environment.
This is an estimate based on the location and requirements of the role.
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