Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company
Associate Director, Analytical Development – Small Molecule
Boston, MA · Director
Sponsorship not specifiedDetected 12 days ago
GMPMass Spectrometry
About the role
- Description of Role Centessa continues to expand its CMC group and currently seeks a n Associate Director of Analytical R&D within the CMC group.
- This position will oversee work with various vendors and oversee analytical functions across programs.
- Comprehensive working knowledge of cGMP and regulatory guidance as they relate to development, testing, characterization, and shelf-life management of biologics is paramount.
Responsibilities
- Support analytical development activities related to method development and qualification/validation, product characterization, and comparability assessment for multiple programs
- Work in a team environment to manage drug substance and drug product analytical development activities primarily at third-party vendors including analytical method implementation, qualification/validation, and transfer for drug substance and drug product projects
- Review analytical documents including but not limited to protocols, reports, and procedures
- review and assemble information for analytical sections in regulatory submission documents (e.g. IND, IMPD, NDA, etc)
- Contribute to CMC analytical aspects of regulatory filings; review and assemble information for analytical sections in regulatory submission documents (e.g. IND, IMPD, NDA, etc)
Requirements
- 10+ years of experience in biotech/pharmaceutical industry in small molecules, working in early to late-development (pre-clinical to phase 3)
- In depth knowledge of assay and related substances development, forced degradation, HPLC/UPLC, GC, KF, XRPD, residual solvents, elemental impurities, microbial testing, dissolution, compendial methods.
- Hands-on experience in carrying out stability studies for drug substance and drug product in development and/or QC settings
- Experience managing DS/DP stability, and knowledge of ICH stability guidelines
- Knowledge of compendial (USP, EP, etc) requirements and standards
- Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or sys
- PhD in Chemistry, Pharmaceutical Sciences, or a related discipline or MS with extensive relevant biotech/pharmaceutical industry experience
- Strong analytical planning and resource management skills in a dynamic environment located across multiple geographies
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