SR. Manufacturing Manager
Core
Lead all aspects of aseptic and non-aseptic manufacturing operations for drug products, ensuring cGMP compliance and sterility assurance.
Role type
Senior IC manufacturing manager (pharmaceuticals)
Builds
Sterile drug products via formulation, filling, stoppering, capping, and lyophilization
Domain
Biopharma / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aseptic process development, cGMP compliance, Root cause analysis, Project management, Budget management, SOP authoring, Change control management, Validation coordination, Team leadership, Sterility assurance principles
Preferred skills
Experience with RABS and other filling technologies, New product introduction support, Technology transfer, Cross-functional collaboration
Technologies
Lyophilization systems, RABS, Cleanroom environments, Aseptic filling equipment
Responsibilities
Manage and direct manufacturing staff for continuous aseptic and non-aseptic operations; Ensure batch record documentation and manufacturing records comply with cGMP; Author, review, and approve investigations, OOS reports, and deviation reports; Coordinate validation protocols and process enhancement projects; Oversee training programs for operators on aseptic technique and contamination control; Support regulatory audits and inspections.
Seniority
Senior, hands-on IC
