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Drug Product Manufacturing Manager

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Dublin
  • Sector: Science
  • Date posted: 30/05/2018
  • Job reference: J387226A

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Drug Product Manufacturing Associate Manager/ Manager

In this position you will be tasked with overseeing and coordinating of the product supply at several my clients external manufacturing sites. The main responsibilities include coordinating activities to support execution at sites, new technology introduction, technology transfer, troubleshooting, relationship management, Supply fulfilment etc.

Main responsibilities:

  • Manage production on site, co-ordinate the actions at external sites to meet my clients supply requirements.
  • Work with the team to managing Site performance.
  • Coordinate activities with CMO's and/or business partner manufacturing sites to support manufacturing, project execution, batch completion and transfer to other locations as needed.
  • Liaise between internal and external groups for example Quality Control, Quality Assurance, Supply and Development departments and contract manufacturers or business partners to plan and execute to plan and manage issue resolution.
  • Lead or participate in projects including process optimisation or improvements, new technology introduction, new component introduction or material changes.
  • Work with the support groups to complete process changes, deviations and risk assessments and other compliance activities as required.
  • Travel to 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.
  • Assist in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.
  • Continuous Process Improvement Implementation.

Requirements:

  • BS scientific discipline with 5+ years of related experience in a pharmaceutical cGMP environment preferred.
  • Aseptic Parenteral Filling operations or development experience.
  • Technology Transfer experience would be an advantage.
  • Previous experience providing technical support and interacting with Contract Manufacturing organisations.
  • Good interpersonal, cross-cultural, communication, negotiation and problem-solving skills
  • Good knowledge of industry practices and regulations (e.g. GxP, ISO, ICH, etc.) across multiple health authorities (e.g. FDA, IMB, etc.)
  • Project management (PMP or equivalent) qualification preferable.

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

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