Associate Manager Quality Control (Microbiology)

Job Overview

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

Typical Day

• 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 providing technical advice on QC related topics as needed
• Participating in the investigation and review of alert and action limit investigations as needed and implementing 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 generating 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 trends

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

Qualifications & Experience

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

Benefits

Regeneron offers inclusive benefits that 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.

Work Location

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 location.

Equal Opportunity Statement

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.

Background Checks

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.