Director/Sr Director QA Microbiology

Regeneron Ireland
Employment Type
Not disclosed
Regeneron Ireland logo

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our outstanding ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Our medicines and pipeline are crafted to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases. Our mission is to use the power of science to bring new medicines to our patients.

Summary: We are currently recruiting for a Director/Senior Director QA Microbiology. Within this role you will provide microbiology expertise as it relates to Drug Substance & Drug Product manufacturing. This sets the strategy for the improvement of practices and procedures that ensure the efficiency of IOPS’ Contamination and Microbial control programs. In addition, we require someone who will support the goal of zero regulatory observations by partnering with the Inspection Management Team (IMT) with inspection preparations and regulatory inspections. You would provide leadership on microbiology related issues to Senior Management and the QA Microbiology team at the respective IOPS’ sites. The successful candidate will report to the QA Microbiology Head of Industrial Operations and Product Supply (IOPS) organisation. As part of the site QA Microbiology management, this position will focus on coaching, mentoring and continuous improvement activities with the team.

A typical day in this role might include the following:

  • Working with QC, Manufacturing, Facility Maintenance and Engineering departments to consistently improve the general facility contamination control program and support remediation efforts where necessary.
  • Supporting investigations pertaining to microbial contamination to assure effective root-cause analysis, corrective action plan determination and remediation plans. Work in conjunction with the directors of the affected department to achieve these goals.
  • Supporting investigations, document reviews and continuous improvement opportunities relating to microbial control and compliance.
  • Maintaining industry standards with respect to microbial control and mitigation – incorporate any new industry standards/use of new monitoring equipment into the IOPS system.
  • Provides input on technology transfer plans related to microbiological method transfers (method validation).
  • Supporting IMT with inspection preparations and regulatory inspections.
  • Reviewing and providing input on the development and modification of microbial action limits.
  • Evaluating and giving input on microbiology SOPs, microbiology assay validation and related documentation.
  • Reviewing and providing input on environmental monitoring SOPs and environmental monitoring protocols.
  • Reviewing and providing strategic support to understanding and leading excursion trend levels.
  • Reporting excursions trends and their interpretation to senior management.
  • Responsible for assessing the efficiency of IOPS sanitization agents.
  • Domestic and foreign travel required.

To be considered for this role we require you to hold a MS/BS degree in microbiology, medical technology, biology or related field and 12 years’ experience (Director Level) or 15 years experience plus (Senior Director level) in the pharmaceutical or biotechnology industry. We also require experience in quality control microbiology, quality assurance and regulatory inspections for Biological pharmaceuticals.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.