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Manager, QA Microbiology (Drug Product)

Employer
Regeneron Pharmaceuticals, Inc.
Location
East Greenbush, New York, US
Salary
Competitive
Closing date
Jul 2, 2024

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Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Biology
Salary Type
Salary
Employment Type
Full time
We are currently looking to fill a Manager, QA Microbiology (Drug Product) position. This position is responsible for being the primary QA Microbiology point of contact related to contract manufacturing operations for drug product. This position includes defining microbial expectations and strategies related to Regeneron microbial control strategies. Evaluation of microbial control changes and proposals, with managing reviews and communications for drug product change controls, process validations, sampling methods, raw material specifications, etc. Communications within the QA Microbiology teams to ensure consistency between internal drug product filling and external filling operations.

In this role, a typical day might include the following:
  • Ability to foster working relationships between Regeneron departmental representatives at all management levels and external contract organization representatives;
  • Ability in evaluating drug product filling operations in relation to microbial control strategies and relevant regulations.
  • Ability to manage projects and people resources without direct reporting structure, to meet deadlines.
  • Participate in multidisciplinary project teams to coordinate and establish training goals;
  • Aid investigation evaluations pertaining to microbial contamination to assure effective root-cause analysis, corrective action plans determination, product impact, and remediation plans;
  • Maintain industry standards with respect to microbial control/ mitigation aid to monitor and incorporate any new industry standards;
  • Staying up to date on developments in best practices relating to relevant technology, contamination/environmental controls, etc.;
  • Review and provide input on SOPs, microbiology assay validation, sterilization, aseptic processing simulations, and related documentation;
  • Review and provide input on environmental monitoring related to drug product filling;
  • Limited domestic and foreign travel may be required.

This role may be for you if you:
  • Have knowledge of current industry microbial control practices and testing methods.
  • Understand all aspects of drug product filling operations; including aspects of APS/SIMS, isolator and RABS technology, and visual inspection.

To be considered for this role you must hold a Bachelors degree in Life Sciences or related field with the following minimum amounts of experience in pharmaceutical or biologics manufacturing environment for each level:
  • Associate Manager 6+ years
  • Manager 7+ years
  • Sr Manager 8+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)
$89,100.00 - $199,000.00

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