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.

#REGNIRLTO #IREADV #JOBSIEST #LI-Onsite

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

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.