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.

Responsibilities

• 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 trend

Qualifications

• 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
• 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

Equal Opportunity Employer

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.

Salary

63 200.00