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Regeneron, Associate Manager QA Microbiology

regeneron

Job Title: Associate Manager QA Microbiology
Location: Limerick, Ireland

Company

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.

Job Summary

Responsible for planning, coordinating and facilitating microbial control activities required for the development and commercialization of Regeneron’s drug candidates. This role will provide ongoing support to evaluate and enhance the site’s compliance to procedures and practices in accordance with current regulatory requirements and industry guidance. This position will report to the Associate Director for QA Microbiology.

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

  • Provide support for investigations pertaining to microbial contamination to ensure identification of effective root-cause analysis, assignment of appropriate corrective actions and determination and remediation plans.
  • Engage directly with site personnel to promote low bioburden operations culture and to provide microbiological subject matter expert knowledge.
  • Provide microbiological support to the internal audit and inspection readiness programs.
  • Provide support for tracking and implementation of corrective and preventative actions related to microbiology and low bioburden operations.
  • The candidate must be familiar with implementation of microbiological environmental monitoring programs and must understand interpretation of microbiological data including evaluation of trends.
  • Support the review and approval of microbial control related documents, including but not limited to, SOPs, validation and qualification documentation, study protocols, risk assessments and deviation/investigations.
  • Communicate updates, metrics and outstanding items to senior personnel when necessary.
  • Provide assurance of consistency of IOPS Microbial programs and initiatives across multiple sites.
  • Perform additional tasks as directed by senior management.

Education and Experience:

  • Requires BS degree in Life Sciences or related field and at least 8 years of relevant experience in the pharmaceutical or biotechnology industries.
  • Experience should also include quality control microbiology, critical utilities and involvement with supporting regulatory inspections.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Go to regeneron.com and learn more about Regeneron’s unwavering commitment to combining good science & good business. To apply please email your CV to aiveen.campbell@regeneron.com.

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.

Applications

To be sent to Aiveen Campbell – aiveen.campbell@regeneron.com