Within this role you will perform testing to ensure cGMP compliance in the manufacturing facility. Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.
A typical day might include, but is not limited to, the following:
- Entering a Laboratory Cleanroom to collect and log samples for microbial analysis
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Performing bioburden and endotoxin sample analysis in accordance with standard operating procedures (SOPs)
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Performing or supporting the sample analysis for microbial identification.
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Performing environmental monitoring including surface, settling, and viable and non-viable particulate air monitoring of aseptic operations and controlled areas.
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Performing acceptance testing of commercially prepared microbiological culture media
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Autoclaving microbiological media and laboratory waste as needed
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Ensuring that all work carried out is in compliance with the required regulatory standards and conforms to company policies and standard operating procedures (SOPs)
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Completing own test records on time and peer reviewing data from other analysts for accuracy and completeness
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Assisting in the design and set-up of the QC microbiology laboratory and the selection, implementation, and calibration of laboratory instruments
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Participating in microbiological validations as needed for drug substance, in-process controls, buffers, and clean utilities qualification programs
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Assisting manufacturing personnel in identifying microbiological root causes and providing technical advice as needed
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Participating in the transfer of methodology from other test facilities.
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Maintaining laboratory reagents, media, and supplies
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Conducting laboratory investigations and generating reports in response to invalid assays, deviations, and OOS/OOT results
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Initiating and completing CAPAs and Change Controls in accordance with site procedures
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Writing new and updating current SOPs as needed
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Providing training to other analysts in the QC group
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Presenting analytical data reports clearly and concisely to management
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Proactively identifying and implementing lab process improvements and lean initiatives
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Performing other duties relevant to the QC laboratory position as required
To be considered for this opportunity, you should have a BS/BA in Life Sciences or an equivalent qualification, along with relevant experience for levels beyond I (preferably in the pharmaceutical or biotechnology industries). Relevant work experience may be considered in place of a degree requirement.
Education and Experience:
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Assoc QC Micro Analyst: Minimum 0-2 years’ experience
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QC Micro Analyst: Minimum 2 years’ experience
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (hourly)
€16.42 - €25.59
