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Project Manager External Manufacturing

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Dublin
  • Sector: Science
  • Date posted: 30/05/2018
  • Job reference: J387230A

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Project Manager External Manufacturing

Coordinates all aspects of clinical and commercial parenteral drug product filling operations including overseeing day-to-day operations, ensuring timely completion of associated operations/documentation and assisting in the monitoring of cGMP compliance at European drug product contract manufacturers.

Main responsibilities

  • Serves as the primary my clients contact for European DP contract manufacturing sites concerning day-to-day activities. Responsible for developing and maintaining these important business relationships.
  • Liaison between my clients Quality Control, Quality Assurance, Operations/Logistics Departments and European contract manufacturers or business partners.
  • Ensure the timely routing and review of all master manufacturing records (MRs), standard operations procedures (SOPs), tech transfer reports, validation master plans, and other documentation related to clinical and commercial drug product manufacturing at contractors and/or business partners.
  • Coordinated all activities to enable DP filling at contract and/or business partner European manufacturing sites, including but not limited to: scheduling of all batches, supplying of requested materials, directing shipment of bulk and finished product at manufacturing sites, tracking of outputs and project step completion times, and providing any required associated reports.
  • Travel to European contract manufacturers or business partners, as required.
  • Provide regulatory filing support (IND, BLA, MAA, etc…)
  • Maintain required training status on my client's specific work instructions and SOP's.
  • Lead sub-team(s) in new projects, continuous process improvements, system implementations and/or strategy development.
  • Write internal investigation or deviation reports which concern DP Manufacturing or associated shipping operations, if required.
  • Support and/or perform internal toxicology and clinical drug product manufacturing
  • Assist in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at European drug product contract manufacturers.

Experience and Required Skills: `

  • BS scientific discipline with 10+ years of related experience in a pharmaceutical cGMP environment preferred; may substitute relevant industry experience in lieu of educational requirement.
  • Industrial experience with aseptic parenteral drug product filling operations.
  • Strong project management (PMP or equivalent), interpersonal, cross- cultural, communication, negotiation and problem-solving skills qualification preferable.
  • Technology Transfer experience an advantage.

For more information on this and other potential opportunities please contact Kathryn on 016455250 for a confidential conversation.