External Manufacturing Manager

Dublin  ‐ Onsite
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Description

A speciality pharmaceutical company is looking to recruit an External Manufacturing Manager on a permanent basis, for their global Operations group based in Dublin.

The Role and Responsibilities:
  • Reporting to the vice president
  • Responsible for the provision of technical and project management oversight of new and ongoing projects within the company's global portfolio of externally manufactured products to ensure consistent security of supply. The projects involve technology transfer, new product introduction, global expansion, strategic sourcing and integration of new product acquisitions into the company's operational business.
  • Demonstrated experience of manufacturing processes and technology transfer relating to a variety of pharmaceutical and medical device dosage forms.
  • Provision of ongoing technical and project management oversight relating to projects within a global portfolio of externally manufactured products.
  • Development and execution of an ongoing risk based strategic sourcing initiative to manage external supply risk
  • Managing technical transfers between contract manufacturing organizations, including technical transfers of products between external manufacturers and from external manufacturers to internal manufacturing sites.
  • Providing technical leadership and oversight during integration of newly acquired products and associated contract manufacturing relationships.
  • Supporting CMO/vendor selection - preparation of technical information packages, participation in due diligence and site assessments.
  • Collaborating across the company's global community of Tech Ops, CMC Regulatory and Project Management functions on shared initiatives.
  • Driving process capability analysis as and when required to assess process robustness.
  • Identifying and executing process robustness improvement projects, where required.


Key Skills and Experience include: .
  • Hands-on experience of a broad range of dosage forms in a commercial manufacturing environment
  • Subject Matter Expert in one or more dosage forms relating to one of more of formulation, process development, process management and trouble shooting, process robustness improvement.
  • Familiarity with CMC regulatory requirements in different regulatory environments.
  • Extensive experience dealing with crosses functional teams in multiple geographies.
  • Extensive experience as the technical lead on Drug Product Technical Transfer projects
  • A degree in a pharmaceutically relevant science is required as a minimum.


A competitive benefits package will be offered for this position commensurate with relevant experience. Please contact me Anna Mooney to here more about the company and the role or apply below with an up to date CV.
Start date
06/2015
From
Real Staffing
Published at
22.04.2015
Project ID:
890281
Contract type
Permanent
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