As a Manager within the QC Microbiology department you will manage the QC Microbiology team and provide critical microbiology support to manufacturing and facilities.In this role. your typical day might include,, but will be not limited to, the following:
- Manage 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.
- Implement and manage the environmental monitoring programme, including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas.
- Responsible for all QC microbiological aspects of cGMP compliance and sample analysis.
- Design and oversee microbiological validations as needed for drug substance, in-process controls and buffers.
- Manage the design, validation and execution of the clean utilities qualification and re-qualification program.
- Support manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice on QC related topics as needed.
- Participate in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate.
- Ensure that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
- Review and approve method protocols, reports and SOPs.
- Assist in the preparation for internal/customer/regulatory inspections.
- Oversee or conduct laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
- Ensure that CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures.
- Train, develop and mentor direct reports and effectively manage the performance of individuals.
To be considered for this position you must hold a BS/BA in Microbiology or closely related field with 7+ years' relevant experience preferably in the pharmaceutical or biotech industry.
#IREADV #JOBSIEPR #REGNQC
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Job number: R16215
Date posted : 2023-04-26
Profession: Industrial Operations and Product Supply
Employment type: Employee