Invenia Group is partnered with a mid-sized generics company, looking for a Head of Manufacturing to come in and head up manufacturing operations of their new sterile facility in Illinois.
Role & Responsibilities
- Leadership of bulk formulation, aseptic filling, and manufacturing divisions.
- Oversee safety in operations, product quality (cGMP), efficiency, and compliance (FDA, DEA, OSHA)
- Close collaboration with client/customer, Process Development, Manufacturing, Engineering, Maintenance, Validation, Quality Control, Microbiology / Environmental Monitoring and Quality Assurance.
- Review and approve batch records, solution records, and SOP’s.
- Review and approve deviation investigations, CAPAs, technical documents, and Change Controls associated with production.
- Support new manufacturing equipment selection, as well as user requirement specification development, protocol development, review and approval, and qualification execution.
- SME as required during regulatory inspections.
- Provide on-the-floor support as required and serve as primary contact for technical aspects within each product campaign.
Skills and experience required
- BA in Manufacturing, Operations, Mechanical or Industrial Engineering, Scientific discipline or similar is preferred.
- Several years’ experience in a pharmaceutical manufacturing leadership position.
- Minimum 10 to 15 years’ experience in pharmaceutical manufacturing preferred.
- Extensive aseptic manufacturing experience.
- LEAN manufacturing experience.
- Previously held P&L responsibility.
- Must have had roles with P&L responsibility and must have working knowledge of budgets and financial statements.
- cGMP, DEA, and OSHA compliance
