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Contact Info
Kevin Silke
Life Science

01 507 9255
[email protected]
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Program Manager
Westmeath
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Details

Project Manager Tech Transfer


Reference:KG-ADSE-827107 Location: Limerick
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed

Would you like to join a leading and well-known pharmaceutical company in Limerick, to further develop your career? This is an excellent opportunty to work with leading technologies in the pharma industry.
As a Project Manager Tech Transfer, you will work with the Manufacturing Sciences and Technology group in the US to transfer manufacturing processes to Ireland and partner facilities.

The position will also focus on ensuring site to site consistency after the processes are successfully transferred. The Project Manager will also provide floor support during operations of manufacturing campaigns, review process data to ensure operational consistency and provide support for investigations.

Responsibilities:
• Work with all relevant departments to coordinate technology transfer activities.
• Assess manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities.
• Review technology transfer protocols and reports, manage document exchange (which includes Regeneron documents such as SOPs, SPECs, validation, raw material and instrument qualification documents, batch records, etc.).
• Provide process transfer support to external facilities, including generation of process descriptions and facility fit comparisons.
• Organize and lead meetings to support transfer activities.
• Track team activities and timelines to ensure that the deliverables within the project plan are met and are on-time.
• Prepare, distribute & present project status reports to project team members and management.
• Manage and set priorities for specific projects/programs.
• Provide technical support and training of manufacturing personnel to improve understanding of both cell culture and purification operations across the manufacturing organization.
• Assist in the writing and review of manufacturing records, batch sheets and SOPs.
Provide manufacturing descriptions and technical evaluations for regulatory filings and inspections.
• Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
• Provide and schedule floor support in the processing areas during manufacturing operations.
• Lead special projects as assigned.

Qualifications & Skills Requirements
• BS in Biological Sciences or Engineering with 8+ years of relevant experience in a cGMP environment; relevant Masters or PhD may be considered in lieu of industry experience.
(Level commensurate with experience.)
• A qualification in Project Management is desirable.

If you meet the minimum Qualifications & Skills Requirements, and feel this is the right role for you, please apply today!