Supervisor, Manufacturing Operations 1st Shift (1B)
Core
Lead first-shift manufacturing operations for drug product facilities, ensuring cGMP compliance and efficient execution of assembly, operation, and cleaning activities.
Role type
Manufacturing Operations Supervisor (1st Shift)
Builds
Drug product batches in compliance with cGMP standards
Domain
Biotechnology / Pharmaceutical Manufacturing (Cell Therapy)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, batch record execution, shift personnel supervision, equipment setup and cleaning, SOP adherence, cross-functional team interface, audit readiness, team coaching, priority management
Preferred skills
cell therapy experience, aseptic manufacturing experience, POMS MES experience, prior supervisory experience
Technologies
POMS MES
Responsibilities
Lead and supervise daily manufacturing operations; Assign work to shift personnel based on production schedules; Oversee cGMP manufacturing activities including equipment setup, assembly, operation, disassembly, and cleaning; Execute and witness batch record instructions; Perform real-time on-the-floor batch record review; Monitor and enforce GMP compliance; Maintain facility in audit-ready state; Interface with cross-functional teams for maintenance and operations support; Lead and attend Tier 0 and Tier 1 meetings
Seniority
Mid-level Supervisor, hands-on IC