Essential Duties & Responsibilities: |
• Provides strategic leadership for bulk formulation, aseptic filling, and manufacturing functions, focused on safety in operations, product quality (cGMP), efficiency, and compliance (FDA, DEA, OSHA) for a portfolio of sterile pharmaceutical products. |
• Responsible for the delivery of product by managing daily operations with input from client/customer, Process Development, Manufacturing, Engineering, Validation, Quality Control, Microbiology / Environmental Monitoring and Quality Assurance. |
• Manage team to ensure safety, compliance, and production goals are reached. |
• Collaborate with Technical Operations to manage the workflows associated with new product introduction and product reintroduction including design of process flow, special handling requirements, equipment fit versus qualified components and processes, bill of materials (BOM) generation, process parameters, automation requirements. |
• Review and approve batch records, solution records, and other SOP’s and protocols for new/existing products. |
• Review and approve deviation investigations, CAPA’s, technical documents, and Change Controls associated with production. Ensure appropriate root cause investigations are completed and effective corrective/preventative actions are implemented. |
• Provide support to the Engineering and Validations teams in preventive maintenance, calibration and equipment and process validation / re-validation activities. |
• Identify and support new manufacturing equipment selection, user requirement specification development, protocol development, review and approval and qualification execution. |
• Provide on-the-floor technical oversight and manage client interactions as required during cGMP manufacturing runs. |
• Serve as SME as required during regulatory inspections for manufacturing operations, departmental training, and associated department deviations, change controls, and process documentation. |
• Compile, analyze, and present manufacturing process data to internal and external program teams. |
• Manage production deliverables associated with active campaigns in assigned manufacturing area. Ensure production teams are meeting safety, compliance, and schedule objectives. |
• Collaborate with Technical Operations and Quality Assurance for batch record review and release timelines. (Repeat of above – so is below) |
• Provide on-the-floor support as required and serve as primary contact for technical aspects within each product campaign. |
• Hire, develop and motivate the team. Serve as a coach and mentor for reports meeting with them at a minimum frequency based on experience to assure objectives are met. |
• In cooperation with customer representatives, process development, engineering, and management personnel, look for opportunities to improve operational efficiencies. |
• Development and adherence to manufacturing department budget. |
• Closely coordinate potential process improvements with quality and regulatory to assure cGMP and DEA product handling compliance. |