Analytical Development, Science and Technology Lead
About The Position
The Analytical Development, Science and Technology Lead is responsible for (including, but not limited to the following:): Experienced subject matter expert (SME) and scientific owner to deliver compliant, robust and relevant analytical methods (IPC, DS and DP) and associated Quality Systems, including specifications for a small molecule product. Ideally, profound previous experience to support the transition of a product from phase 3 CMC development to commercial readiness meeting all relevant regulatory and legislative requirements. Responsible to oversee and manage development as well analytical routine activities at CLO/CMO; incl. release testing and stability studies, investigating and solve issues and queries. Support in the design of submission-enabling stability study-programs, assessing shelf life and ensuring relevance of analytical methods Responsible for continuous method verification including analysis of trend data, establishing and review method lifecycle to maintain, develop and validate analytical methods to support quality and process understanding Design and lead the analytical transfer workstreams of drug substance and drug product transfers from development to commercial site and between commercial sites, method qualifications as well as validations and provide training of external labs. Support the development, refinement, and implementation of robust and compliant product control strategies by ensuring analytical method capabilities, specifications, and stability data are fully aligned with quality and process understanding Lead internal activities related to external manufacturing such as assessments of analytical changes, major/critical deviations, risk assessments and CAPAs Oversee the establishment and maintenance of reference materials and responsibility for product specific method standards and qualified materials (critical reagents), including coordination of shipping of samples and reagents Write and review applicable sections in registration filings, variations and market expansion Issue, review and approve applicable internal and external SOP's and CMO manufacturing instructions. Keep up to date with relevant regulatory and legislative requirements and assessment of testing monographs
Requirements
- University education in Analytical Sciences or equivalent.
- +5-10 years of progressive experience in analytical development, method validation, and QC/QA interactions for small‑molecule, non‑sterile drug products.
- Demonstrated experience overseeing analytical activities at CLOs/CMOs, including release and stability testing, troubleshooting, investigations, and lifecycle management of analytical methods
- Recognized expert of analytical methods for small molecules (HPLC, UPLC, GC, dissolution, residual solvents, impurities profiling, forced degradation, etc.)
- Demonstrable experience of working in cross functional team with ability to lead functional teams, prioritize and be an effective decision maker
- Experience defining control strategies, including ICH Q2, Q3C, Q3D, M7
- Experience of regulatory guidelines (FDA & EMA), regulatory authorities communication and filing documentation.
- Fluent in English
Nice To Haves
- intermediate to full proficiency in Chinese is a plus.
- Background in Drug Product manufacturing in hard‑gelatine capsules is a plus
Responsibilities
- Deliver compliant, robust and relevant analytical methods (IPC, DS and DP) and associated Quality Systems, including specifications for a small molecule product.
- Support the transition of a product from phase 3 CMC development to commercial readiness meeting all relevant regulatory and legislative requirements.
- Oversee and manage development as well analytical routine activities at CLO/CMO; incl. release testing and stability studies, investigating and solve issues and queries.
- Support in the design of submission-enabling stability study-programs, assessing shelf life and ensuring relevance of analytical methods
- Responsible for continuous method verification including analysis of trend data, establishing and review method lifecycle to maintain, develop and validate analytical methods to support quality and process understanding
- Design and lead the analytical transfer workstreams of drug substance and drug product transfers from development to commercial site and between commercial sites, method qualifications as well as validations and provide training of external labs.
- Support the development, refinement, and implementation of robust and compliant product control strategies by ensuring analytical method capabilities, specifications, and stability data are fully aligned with quality and process understanding
- Lead internal activities related to external manufacturing such as assessments of analytical changes, major/critical deviations, risk assessments and CAPAs
- Oversee the establishment and maintenance of reference materials and responsibility for product specific method standards and qualified materials (critical reagents), including coordination of shipping of samples and reagents
- Write and review applicable sections in registration filings, variations and market expansion
- Issue, review and approve applicable internal and external SOP's and CMO manufacturing instructions.
- Keep up to date with relevant regulatory and legislative requirements and assessment of testing monographs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
