CMC Expert M/F (CDI)
Core
Develop and manufacture new drug candidates, including synthesis route optimization, scale-up, technology transfer, and CMC dossier preparation for regulatory submission.
Role type
Senior CMC Expert (Chemistry)
Builds
New drug candidates and regulatory dossiers
Domain
Pharmaceutical R&D / Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC expertise, small molecule synthesis, scale-up process, technology transfer, analytical chemistry, cGMP, project management, CDMO management, regulatory affairs
Preferred skills
Technical leadership in chemistry, cross-functional collaboration
Technologies
cGMP, IND/IMPD/NDA/MAA documentation
Responsibilities
Propose pharmaceutical strategy and transcribe into dossiers, conduct CMC quality reviews, analyze product issues, manage CMC work packages, monitor work quality/cost/timeframe, represent company to authorities, define chemistry budget, support life cycle management programs
Seniority
Senior, hands-on IC