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Regeneron Ireland

Assoc Mgr Process Sciences - Manufacturing Support

Regeneron Ireland

  • Limerick
  • See description
  • Permanent full-time
  • Updated 07/02/2018
  • Regeneron Pharmaceuticals
this job is expired
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Description

Responsible to support the Process Sciences Department through Process Validation, manufacturing floor support, product impact assessments, investigations, and technical evaluation as required.

 

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: Responsible to support the Process Sciences Department through Process Validation, manufacturing floor support, product impact assessments, investigations, and technical evaluation as required. Active member of the Process Sciences management team.

Essential Duties and Responsibilities include, but are not limited to, the following:
* Lead a shift team and manage all activities to assure that manufacturing processes are supported. Responsible for developing a team such as development plans, upskilling and team forming.
* Provide on the floor support to Manufacturing as part of a shift structure as required.
* Lead/Participate Process and Quality risk assessments.
* Lead troubleshooting activities associated with the manufacturing process.
* Provide technical support for manufacturing personnel to improve understanding of both cell culture and purification operations.
* Review and approve manufacturing documentation such as manufacturing records, SOPs and batch sheets.
* Develops/writes/plans and reviews protocols and activities for manufacturing support.
* Presents and reviews process monitoring data to IOPS Management as necessary.
* Investigates and reviews OOS and OOT IPCs investigations.
* Performs, reviews and approves product impact assessment.
* Performs, reviews and approves scientific investigations (EOE & DNF).
* Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer.
* Support the site through regulatory audits by providing technical expertise.
Work efficiently and effectively in a fast paced team-oriented environment to ensure maximum and high-quality output.

Will be required to work shift patterns to meet business needs and the production schedule as required

Education and Experience:
* Requires a BS/BA in Life Sciences, Biological Sciences or related field with 5+ years of relevant experience in a GMP environment.
* Ideal candidate has previous experience in biological drug substance (DS) manufacturing.
* Previous supervisory and/or leadership experience required.
* Experience in Cell Culture and/or Purification is desirable.

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: 11522BR_1515674930
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Regeneron Ireland

Regeneron Ireland

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