Associate Director, CMC, Drug Substance
Core
Manage and oversee the development and manufacturing of cGMP small molecule active pharmaceutical ingredients (APIs) for pre-pivotal and pivotal clinical trials.
Role type
Associate Director, CMC Drug Substance
Builds
cGMP small molecule APIs for clinical trials and commercial deployment
Domain
Biopharmaceuticals / Neuroscience / Small molecule chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP regulations, CDMO management, process technology transfer, regulatory document authoring, budget management, vendor contracting, risk-based decision-making
Preferred skills
Experience with virtual manufacturing settings, strategic thinking, problem-solving
Technologies
cGMP, IND/NDA/MAA filings
Responsibilities
Manage API development and manufacturing campaigns; Evaluate and manage qualified CDMOs; Collaborate on process technology transfer; Translate clinical demand forecasts into manufacturing plans; Author and review core CMC documents for regulatory submissions; Participate in CDMO audits and inspections; Manage API-related project budgets
Seniority
Senior, hands-on IC
