Summary: The Manufacturing Supervisor will work directly with a range of purification technologies including continuous flow centrifugation, sucrose gradient separation, various filtration technologies (TFF & depth), chromatographic separations technologies (GE AKTA systems), and viral inactivation following aseptic technique in a cGMP environment. This individual will also supervise a team of employees directly or indirectly in the Downstream or Upstream process.
- Operation and familiarity with the following systems:
- Large-scale filtration systems including Tangential Flow Filtration (TFF) and depth filtration.
- Large-scale centrifugation systems including Sucrose Density Centrifugation, Continuous Flow Centrifugation, and Clarification.
- Large-scale Chromatographic systems (ÄKTA).
- Experience with single use systems.
- Responsible for supervising daily manufacturing activities and staff, including hiring, performance evaluations, coaching, mentoring, disciplinary actions, termination recommendations, training, development, etc.
- Responsible for implementing project safety and quality assurance programs.
- Develop, write, and review Standard Operating Procedures and Batch Production Records (BPRs).
- Responsible for ensuring proper documentation and execution of BPRs and activity records, according to cGMP regulations.
- Lead deviation resolution and closure with subject matter expert and quality teams.
- Responsible for tracking CAPAs to closure.
- Provide input and support to R&D functions during development and scale-up activities as necessary.
- Represents organization in client meetings as the subject matter expert with regard to assigned manufacturing processes.
- Ensure an adequate supply of materials available; ensure all materials for project(s) are procured prior to production.
Required Skills & Abilities:
- Demonstrated experience in training others to perform and maintain cGMP standards
- Excellent skills with Microsoft Office applications (Word, Excel, PowerPoint).
- Must have flexible work hours, and be willing to work outside of normal, scheduled hours, as necessary. Must be able to work alternative shift hours and weekends as required.
Minimum Education Qualifications:
- High School or Associates Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 10 years of experience in a manufacturing environment which includes 5 years of GXP experience and lead or supervisory experience.