Position Summary | The Manufacturing Supervisor supports and directs Manufacturing Leads and Associates in the formulation, filling, component prep and lyophilization of sterile, injectable biological products within the production and quality goals set by management. |
Duties and Responsibilities | - 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
- 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
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Regulatory Responsibilities | - 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
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Supervisory Responsibilities | - 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
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Experience | - Familiar with cGMP regulations and principles and how to apply them to the manufacturing of pharmaceutical/biotech products
- Three (3) years related pharmaceutical production operations experience within component preparation, formulation and filling or proven ability of same
- Prior supervisory experience
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Education | - Bachelor’s degree in a related field
- An equivalent combination of education and experience may be considered
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Knowledge, Skills & Abilities | - cGMP
- Pharmaceutical production
- Perform effectively in fast-paced, stressful environment
- Supervisory skills
- Troubleshooting
- Mechanical aptitude
- Quality assurance
- Attention to detail
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Physical Requirements | - Ability to meet gowning requirements for cleanroom activities
- Able to lift up to approximately 15-50 pounds frequently and up to 50 lbs. occasionally
- Frequent standing and walking throughout the facility
- Use of both hands and arms in repetitive motion
- Fine and gross motor skills
- Satisfactory audio-visual acuity
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