Position Summary:
Supervises downstream related activities and staff responsible for cGMP drug product manufacturing, including bulk and fill/pack manufacturing shifts, process scale-up, production-efficiency improvements, scheduling commercial-scale development activities, cGMP operations supervision, troubleshooting, hands-on batch operations, and assessing product performance. Authors/reviews/approves cGMP documents including SOPs, batch records, deviations, process descriptions, validation protocols, and development protocols/reports. Collaborates with QA/QC, Manufacturing Technical Services, Facilities Engineering, Formulation Research, Process Technology, and Validations. Work schedule: 2nd shift (2:00pmβ10:30pm), MondayβFriday. 10% shift differential.
Essential Duties & Key Responsibilities:
- Supervise bulk and semi-finished drug product manufacturing floor/line operations
- Supervise/coordinate Commercial Manufacturing support groups
- Oversee clean room and potent compound facility manufacturing operations
- Supervise off-shifts, PTOs, and vacation coverage
- Train manufacturing associates on bulk and fill/pack processes
- Author/revise SOPs and Master Batch records
- Investigate and complete manufacturing deviations
- Cover other manufacturing supervisor shifts as needed
- Ensure manufacturing meets domestic/foreign regulatory and MannKind procedures
- Coordinate development activities for product platforms without significant schedule impact
- Short-term plan bulk/fill-pack activities to support master production schedule
- Observe all Company, Health, Safety, and Environmental guidelines
Minimum Qualifications / Required Skills:
- High school diploma with 10+ years related manufacturing/supervisory experience OR AA (8 years) OR BS (8 years) OR BS (4 years)
- High knowledge of pharmaceutical process technologies, equipment, and drug product manufacturing
- Strong knowledge of pharmaceutical quality standards
- Experience writing/implementing SOPs in a GMP environment
- Medical clearance to wear a respirator for the entire shift
- Ability to gown/de-gown (up to three clean-room/potent-compound layers, incl. Tyvek)