(Associate) Director, Drug Product Operations
Core
Lead drug product strategy and execution for early-stage biologics pipeline from pre-clinical through Phase 2, owning formulation, process development, and CDMO partnerships.
Role type
Associate Director, Drug Product Operations (CMC)
Builds
Early-phase clinical drug products (small molecules, biologics, oligos) for metabolic disease and neuroscience programs
Domain
Biopharmaceuticals / Drug Product Operations / CMC
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Drug product strategy, process development, technology transfer, CDMO selection and management, regulatory submission authoring (CMC sections), cross-functional risk management, budget and timeline management
Preferred skills
Combination products knowledge, delivery device expertise (pre-filled syringes, autoinjectors), analytical sciences fluency, clinical supply chain experience
Technologies
Chromatography, UFDF, aseptic filling, pre-filled syringes, cartridges
Responsibilities
Define FIH and Phase 2 drug product strategy including formulation and container selection; Lead process development and tech transfer from development to clinical manufacturing; Manage CDMO selection, contracting, and technical oversight; Author CMC sections for INDs and Phase 2 filings; Bridge upstream drug substance and downstream clinical supply functions; Manage technical budgets and timelines for early-phase programs
Seniority
Senior, hands-on IC