At MannKind our employees are our number one asset, and we continue becoming a tight-knit community where each of us plays a critical role in our collective success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.
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 manufacturing shifts, scale-up of processes, innovating novel approaches to improve production efficiency, scheduling and assisting in development activities at the commercial scale related to process and equipment, supervision of cGMP operations, troubleshooting production challenges, hands on support during commercial manufacturing batches, and assessing product performance. Execute against and author, review, and approve various cGMP documents such as standard operating procedures, batch records, deviations, process descriptions, validation protocols, and development protocols / reports as required. Collaborate with Quality Assurance, Quality Control, Manufacturing Technical Services, Facilities Engineering, Formulation Research, Process Technology and Validations.
**This is a 2nd shift, Monday to Friday. Additional $300. biweekly 2nd shift stipend.**
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-shift, PTO and vacation coverage
- Train new manufacturing associates on bulk manufacturing processes
- Author and revise Standard Operating Procedures
- Author and revise Master Batch records
- Report, investigate and complete manufacturing deviations
- 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 12+ years related manufacturing / supervisory experience or AA degree with 10 years or BS degree with 6-8+ 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).
Mannkind Corporation
May 02, 2025 