Associate Manager Quality Control (Microbiology)

Within this role you will manage the QC Microbiology team and provide critical microbiology support to manufacturing and facilities.

A typical day might include, but is not limited to, the following:

• Managing a team of laboratory analysts within the QC microbiology department involved in the analysis of raw materials, intermediates (in process) and bulk drug substance in a cGMP regulatory environment
• Implementing and managing the environmental monitoring programme, including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas
• Managing QC microbiological operations to ensure compliance with cGMP standards and accurate sample analysis
• Designing and overseeing microbiological validations as needed for drug substance, in-process controls and buffers
• Managing the design, validation and execution of the clean utilities qualification and re-qualification program
• Supporting manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice on QC related topics as needed
• Participating in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate
• Ensuring that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs)
• Reviewing and approving method protocols, reports and SOPs
• Assisting in the preparation for internal/customer/regulatory inspections
• Ensuring a safe working environment within the laboratory
• Overseeing or conducting laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT
• Ensuring that CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures
• Presenting analytical data reports clearly and concisely to senior management, including QC performance metrics and trend

This role might be for you if:

• You have the ability to train, develop and mentor direct reports and effectively manage the performance of individuals
• You can proactively identify and implement lab process improvements, lean initiatives

To be considered for this opportunity you should have a BS/BA in Microbiology or closely related field with 6+ years’ experience in microbiology lab, preferably in the pharmaceutical or biotech industry with 3+ years’ experience in a leadership role in microbiology laboratory management.

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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 (annually)