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Regeneron Ireland

Project Manager, Technology Transfer

Regeneron Ireland

  • Limerick
  • See description
  • Permanent full-time
  • Updated 23/10/2017
  • Regeneron Pharmaceuticals
this job is expired
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Description

Summary: Based at the Raheen, Limerick site, the Project Manager will work with the Manufacturing Sciences and Technology (MSAT) group in Rensselaer, New York to transfer manufacturing processes to Raheen and partner facilities.

 

Regeneron offers a unique, world-class opportunity for interested candidates. Regeneron has been consistently ranked a "Top Employer" in Science Magazine's rankings for pharmaceutical and biotechnology companies. Regeneron is fully committed to bringing its award-winning approach to Regeneron Ireland, its subsidiary in Ireland, and is looking for outstanding people who are excited by a start-up environment, recognize the opportunities that this offers and wants to be challenged.

Summary: Based at the Raheen, Limerick site, the Project Manager will work with the Manufacturing Sciences and Technology (MSAT) group in Rensselaer, New York to transfer manufacturing processes to Raheen 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.

Essential Duties and Responsibilities include, but are not limited to, the following:
* 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.

Education and Experience
* BS in Biological Sciences or Engineering with 7+ 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.

Knowledge and Skills:
* Ability to communicate clearly the timelines and important milestones
* Ability to adapt to a quickly changing environment.
* Solid knowledge of cGMP and other applicable regulations.
* Ability to effectively communicate issues and ideas with peers and with management.
* Ability to facilitate meetings with cross functional teams.
* Demonstrated interpersonal, written, and oral communication skills.
* Ability to build effective working relationships throughout the organization.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron Ireland is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, family status, marital status, age, disability, sexual orientation, religion, race, national or ethnic origin, gender identity or any other characteristic protected by law.



To apply for this position please click here

Ref: 6781BR_1506420945
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Regeneron Ireland

Regeneron Ireland

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