Associate Director, Technical Operations - Small Molecule Drug Product
Core
Provide technical leadership and operational support for the startup, technology transfer, validation, and ongoing commercial manufacture of oral solid dosage forms.
Role type
Associate Director, Technical Operations (Small Molecule Drug Product)
Builds
Oral solid dosage forms (tablets, capsules) for patients in the U.S.
Domain
Biopharmaceuticals / Small Molecule Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Oral solid dose manufacturing, Process engineering and scale-up, Process and equipment validation, cGMP operations, Deviation management and root cause analysis, Capital project management, Team leadership and development
Preferred skills
None explicitly stated beyond current employee/contingent worker status
Technologies
DeltaV, Electronic batch records
Responsibilities
Lead process scale-up, technology transfer, and validation activities; Provide technical oversight for blending, granulation, roller compaction, tablet compression, and film coating; Lead deviation investigations, OOS, and CAPA; Drive continuous improvement in yield, cycle time, and cost; Lead and develop a team of technical specialists and engineers; Ensure compliance with cGMP and regulatory expectations
Seniority
Senior, hands-on IC with leadership responsibilities
