Head of Manufacturing

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About the job

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