Sr Manager, Production
Core
Overall management of Aseptic and/or Isolator filling operations, including commodity preparation, formulation, lyophilization, and production personnel coordination.
Role type
Senior Manager, Manufacturing Operations
Builds
Injectable pharmaceutical products
Domain
Pharmaceutical manufacturing (FDA-regulated)
Required skills
Manufacturing operations leadership, Aseptic filling expertise, cGMP compliance, Equipment validation, Process improvement, Risk assessment, FDA regulatory knowledge
Preferred skills
Engineering or Life Sciences degree, FDA-regulated environment experience, Aseptic pharmaceutical manufacturing experience
Technologies
Lyophilization equipment, Isolator systems, Aseptic filling lines
Responsibilities
Provide leadership for production scheduling, incoming quality control, manufacturing operations, quality assurance, engineering, maintenance, and equipment validation. Partner with cross-functional teams to implement new equipment and manufacturing processes. Establish operational goals and develop strategies to achieve business objectives. Ensure compliance with FDA requirements and cGMP. Lead complex operational initiatives to strengthen manufacturing infrastructure and regulatory compliance. Coach and develop the manufacturing organization to enhance technical capabilities and product quality.
Seniority
Senior, hands-on IC
