Chemical Expert CMC -CDI- M/F
Core
Lead drug substance (DS) development, manufacturing, and CMC strategy for new drug candidates, ensuring regulatory compliance and quality.
Role type
Senior CMC Chemical Expert (Drug Substance)
Builds
New drug candidates (small molecule synthesis, scale-up, technology transfer)
Domain
Pharmaceutical R&D / CMC / Drug Substance
Required skills
CMC expertise, small molecule synthesis, scale-up process, technology transfer, impurity characterization, regulatory dossier preparation (Module 3), cGMP, project management, budget management
Preferred skills
CDMO management experience, technical leadership in chemistry, life cycle management, nitrosamines/ethylene glycol assessment
Technologies
cGMP, IND/IMPD/NDA/MAA regulatory submissions
Responsibilities
Propose pharmaceutical strategy and transcribe into CMC dossiers; Analyze DS chemistry issues and assess resolution work; Provide chemical expertise for cross-functional collaboration and CMC outsourcing; Monitor work quality/cost/timeframe with subcontractors; Represent CMC expertise to authorities; Define and manage chemistry budget; Support life cycle management and regulatory changes.
Seniority
Senior, hands-on IC with technical leadership