Chemical Expert CMC -CDI- M/F
Core
Lead drug substance (DS) development, manufacturing, and CMC strategy for new drug candidates from synthesis to registration.
Role type
Senior CMC Chemical Expert (Drug Substance)
Builds
New drug candidates (small molecule synthesis routes, scale-up, technology transfer)
Domain
Pharmaceutical R&D / CMC / Drug Substance Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC expertise (Module 3), small molecule synthesis route optimization, scale-up process, technology transfer, impurity characterization, regulatory dossier preparation (IND/IMPD/NDA/MAA), CDMO management, project management, budget management, cGMP compliance
Preferred skills
Technical leadership in chemistry, cross-functional collaboration with clinical/regulatory/quality teams, nitrosamines/ethylene glycol assessment
Technologies
cGMP, CDMO platforms, regulatory submission systems
Responsibilities
Propose pharmaceutical strategy and transcribe into CMC dossiers; Analyze DS chemistry issues and assess resolution work; Provide chemical expertise and CMC watch for new projects; Monitor work quality/cost/timeframe with internal departments and subcontractors; Represent CMC chemistry expertise to authorities; Define and manage chemistry budget for development phases; Support life cycle management and regulatory changes for assets and raw materials
