What are the responsibilities and job description for the Associate IV, Manufacturing Operator 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.
Job Summary:
Supervises downstream related activities and staff responsible for cGMP drug product manufacturing. These responsibilities include but are not limited to the supervision of various clinical manufacturing operations in all phases, scale-up of processes into and out of the clinical phases, including scale up to commercial, innovating novel approaches to improve production efficiency, scheduling of development activities at the clinical scale, supervision of cGMP operations, troubleshooting production challenges, hands on operations during clinical manufacturing batches, and assessing product performance. Executes against and authors, reviews, and approves various cGMP documents such as standard operating procedures, batch records, 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. Assists in setting up and maintaining clinical manufacturing areas in phase-appropriate cGMP status.
Job Responsibilities:
* Supervise the clinical manufacturing floor/line operations of bulk and semi-finished drug product
• Supervise/ Coordinate Clinical Manufacturing support groups
• Manage upset conditions in operations and handle or assist in deviations/investigations/CAPAs
• Supervise all activities in order to establish and maintain Clinical Manufacturing Clean Room Areas including participating in and overseeing manufacturing operations, room cleaning, materials inventorying, transition to and from R D mode, etc.
• Train new manufacturing associates on clinical manufacturing processes and operations
• Performance review of existing manufacturing staff members / direct reports
• Propose revisions to batch records and assist in implementation of those agreed upon
• Author and revise Standard Operating Procedures, Bills of Materials, etc.
• Ensure facility and process related equipment is available for manufacturing activities when needed, including, but not limited to, coordination of qualification, calibration, maintenance, logbook, etc. activities
• Ensure that manufacturing is conducted according to domestic and foreign regulatory agency requirements and MannKind procedures
• Coordinate the clinical manufacturing development activities of existing and new products at all stages of development
• Short term planning of clinical manufacturing activities to support overall clinical production schedule
• Responsible for observing all Company, Health, Safety and Environmental guidelines.
Job Qualifications:
• High school diploma with 10 years related manufacturing / supervisory experience or AA degree with 8 years or BS degree with 4 years
• High level of knowledge with process technologies, equipment, and manufacturing of pharmaceutical drug products.
• Experience in R D and Development of pharmaceutical 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).
