Supervisor, Manufacturing; 2nd Shift

Position

Supervisor, Manufacturing (2nd Shift 2:00pm - 10:30pm, Mon-Fri)

Danbury, CT

112951

1

Supervises downstream related activities and staff responsible for cGMP drug product manufacturing. Responsibilities include supervision of bulk and fill/pack manufacturing shifts, scale‑up of processes, innovation of novel approaches to improve production efficiency, scheduling of development activities at commercial scale, supervision of cGMP operations, troubleshooting production challenges, hands‑on operations during commercial manufacturing batches, and assessment of product performance. Executes, authors, reviews, and approves various cGMP documents such as SOPs, batch records, deviations, process descriptions, validation protocols, and development protocols/reports.

Collaborates with Quality Assurance, Quality Control, Manufacturing Technical Services, Facilities Engineering, Formulation Research, Process Technology, and Validations. Shift: 2nd shift, 2:00pm–10:30pm, Monday through Friday. 10% shift differential.

• Supervise the manufacturing floor/line operations of bulk and semi‑finished drug product
• Supervise / Coordinate Commercial Manufacturing support groups
• Supervise departmental activities to maintain Commercial Manufacturing Clean Room and Potent Compound Facility areas, including participation and overseeing manufacturing operations
• Supervise off‑shifts, PTOs and vacation 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 manufacturing is conducted according to domestic and foreign regulatory agency requirements and Mann Kind procedures
• Coordinate 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
• Observe all Company, Health, Safety and Environmental guidelines

• 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
• Willing and able to receive medical clearance to wear a respirator (PAIR) for entire working shift
• Physically able to gown and de‑gown (including use of a decontamination fogging shower) in up to three layers of clean room and potent compound facility gowning (Tyvek jumpsuit)

$40.40 - $60.60 per hour