The Manufacturing Supervisor supports and directs /Manufacturing Leads and Associates in the formulation, filling, component prep and visual inspection of sterile, injectable biological products within the production and quality goals set by management.
- Oversee personnel and activities related to the production process ensuring compliance with cGMPs and BSM-specific policies and procedures
- Maintain and report metrics to evaluate performance of assigned manufacturing unit
- Compile area specific shift information and accurately convey information to oncoming shifts, management team and support groups
- Maintain and support metrics to evaluate performance of assigned shift
- Provide technical expertise in component preparation, formulation and filling and visual inspection.
- Support operational and preventive maintenance of area specific processing equipment
- Report and investigate Quality deviations and events
- Report and participate in the investigation of safety incidents
- Act in place of manufacturing manager in their absence
- Demonstrate BSM values and behaviors at all times
- Attend and complete all mandatory training
- Maintain continued education and proficiency in field through education, literature and seminars
- Other duties as assigned
- Carryout all duties in compliance with regulatory and professional agencies, including but not limited to state, FDA, OSHA and EU regulations, or otherwise as applicable
- Directly supervise four (4) to eight (8) team members to include:
interviewing, hiring and training employees
planning, assigning and directing work
appraising performance
- rewarding and disciplining employees
- addressing complaints and resolving problems
- Familiar with cGMP regulations and principles and how to apply them to the manufacturing of pharmaceutical/biotech products
Requirements:
- Three (3) years related pharmaceutical production operations experience within component preparation, formulation, filling and visual inspection or proven ability of same
- Prior supervisory experience a plus
- Bachelor’s degree preferred
- An equivalent combination of education and experience may be considered