Manager, Technical Operations
Core
Lead and manage a technical operations team to meet quality, quantity, time, cost, and safety objectives in pharmaceutical manufacturing.
Role type
Manager, Technical Operations
Builds
Commercial sterile pharmaceuticals and New Product Introduction (NPI) processes
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical manufacturing processes, GMP compliance, Statistical Process Controls, Change control management, Quality investigations, Process validation, Root cause analysis, Continuous Process Verification (CPV), Annual Product Review (APR), EHS safety practices
Preferred skills
Managing people, Sterile injectable drug production, Packaging and visual inspection, Engineering and validation batches
Technologies
None explicitly stated
Responsibilities
Provide oversight and coaching to the technical operations team; Lead complex quality investigations and change controls; Author technical operations protocols and reports; Supervise NPI development studies and qualification activities; Monitor and adjust process parameters and critical quality attributes; Ensure robustness of transferred production processes; Participate in safety activities and HAZOPS; Support health authorities' inspections.
Seniority
Manager, hands-on leadership