Supervisor, Manufacturing (2nd Shift)

Position Summary

Supervises downstream related activities and staff responsible for cGMP drug product manufacturing. These responsibilities include but are not limited to the supervision of bulk and fill/pack manufacturing shifts, scale-up of processes, innovating novel approaches to improve production efficiency, scheduling of development activities at the commercial scale, supervision of cGMP operations, troubleshooting production challenges, hands on operations during commercial manufacturing batches, and assessing product performance. Executes against and authors, reviews, and approves various cGMP documents such as standard operating procedures, batch records, deviations, process descriptions, validation protocols, and development protocols / reports as required. Collaborates with Quality Assurance, Quality Control, Manufacturing Technical Services, Facilities Engineering, Formulation Research, Process Technology and Validations. Work Schedule is 2nd shift: 2:00pm to 10:30pm, Monday through Friday. 10% Shift Differential.

Essential duties and key job responsibilities and essential functions:

• Supervise the manufacturing floor/line operations of bulk and semi-finished drug product
• Supervise / Coordinate Commercial Manufacturing support groups
• Supervise departmental activities in order to maintain Commercial Manufacturing Clean Room and Potent Compound Facility Areas including participation and overseeing manufacturing operations
• Supervise off-shifts, PTOs and vacations coverage
• Train new manufacturing associates on bulk and fill/pack manufacturing processes
• Author and revise Standard Operating Procedures
• Author and revise Master Batch records
• Investigate and complete manufacturing deviations
• Cover work shifts of other manufacturing supervisors on vacation or PTO, as necessary.
• Ensure that manufacturing is conducted according to domestic and foreign regulatory agency requirements and MannKind procedures
• Coordinate the development activities of existing and new product platforms without significant impact to production schedule
• Short term planning of bulk and fill/pack manufacturing activities to support master production schedule
• Responsible for observing all Company, Health, Safety and Environmental guidelines.

Duties and responsibilities are not limited to the work listed above and may include other assignments

Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any.

• High school diploma with 10+ years related manufacturing / supervisory experience or AA degree with 8 years or BS degree with 8 years or BS degree with 4 years
• High level of knowledge with process technologies, equipment, and manufacturing of pharmaceutical drug products.
• Strong knowledge of pharmaceutical quality standards.
• Experience writing and implementing SOPs in a GMP environment.
• Must be willing and able to receive medical clearance to wear a respirator (i.e., Powered Air Purifying Respirator) for entire working shift.
• Must be physically able to gown and de-gown (including the use of a decontamination fogging shower) in up to three layers of clean room and potent compound facility gowning (i.e., Tyvek® jumpsuit).