Associate Director, Technical Operations - Small Molecule Drug Substance
Core
Provide technical leadership and operational support for the startup, technology transfer, validation, and ongoing commercial manufacture of active pharmaceutical ingredients (APIs) at a small molecule manufacturing site.
Role type
Associate Director, Technical Operations (Small Molecule Drug Substance)
Builds
Active Pharmaceutical Ingredients (APIs) for commercialization
Domain
Biopharmaceutical / Small Molecule Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process chemistry, Chemical synthesis, Purification, Crystallization, Process scale-up, Technology transfer, Process validation, cGMP compliance, Deviation management, Root cause analysis, Capital project management, Team leadership
Preferred skills
Process optimization, Debottlenecking, Batch record management, Cross-functional collaboration
Technologies
DeltaV, Electronic batch records
Responsibilities
Lead process scale-up and technology transfer activities; Provide technical oversight for API manufacturing processes including chemical synthesis and purification; Drive continuous improvement in process performance and yield; Lead deviation investigations and support inspection readiness; Lead and develop a team of technical specialists and engineers
Seniority
Senior, hands-on IC with leadership responsibilities
