What are the responsibilities and job description for the Manager, Commercial Manufacturing position at MannKind Corporation?
MannKind
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
Job Summary:
Responsible for managing the successful execution of activities related to the cGMP manufacturing of pharmaceutical compounds in support of the company’s business objectives. Manages downstream related activities and staff responsible for cGMP drug product manufacturing. These responsibilities include but are not limited to bulk drug manufacture, filling and packaging and final patient kit assembly as well as innovating novel approaches to improve production efficiency, oversight of cGMP operations, troubleshooting production challenges, and assessing product performance. Executes against and authors, reviews, and approves various cGMP documents such as standard operating procedures, batch records, process descriptions, deviations, investigations, validation protocols, and development protocols / reports as required. Acts as on the floor supervisor across all unit operations as necessary to cover Manufacturing Supervisor PTOs, which may include working overnight shifts. Collaborates with Quality Assurance, Quality Control, Technical Manufacturing Services, Facilities Engineering, Formulation Research, Process Technology, EH&S and Validations.
Essential duties and key job responsibilities and essential functions.
- Manage the day-to-day activities of a commercial manufacturing group specifically focused on the evening and overnight shifts.
- Provides technical expertise and resources for the validation of both equipment and process.
- Ensure compliance with all appropriate Federal Drug Administration (FDA) and other regulatory agency guidelines.
- Develop, review and revise SOPs and batch records to support GMP manufacturing.
- Collaborates with Quality to ensure that all, products are manufactured according to specifications and are released in a timely manner.
- Provide commercial manufacturing input into failure investigations, deviations and CAPAs.
- Supervise employees, responsible for performance reviews and employee development. Participates in recruiting and training of new employees.
- Responsible for observing all Company, Health, Safety and Environmental guidelines.
- Supervise manufacturing floor/line operations of bulk and semi-finished drug product as necessary to cover Manufacturing Supervisor PTOs. This may include working the overnight shift.
- Manage departmental activities to maintain Commercial Manufacturing Clean Room and Potent Compound Facility Areas including participation and overseeing manufacturing operations
- Short term planning of bulk and fill/pack manufacturing activities to support master production schedule
- 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.
- Experience supervising/managing manufacturing operations.
- Familiarity with performance metrics and the capacity to act on facts
- Excellent written and verbal skills and the ability to communicate clearly, concisely and effectively
- 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).
