Microbiology Laboratory Supervisor

Microbiology Laboratory Supervisor

The QC Micro Laboratory Supervisor is dedicated to managing the Microbiology Laboratory and EM Monitoring Program.  The role of the QC Micro Laboratory Supervisor will be that of a Subject Matter Expert for any lab or EM as related to Microbiology, Testing, Aseptic Practices, Environmental Monitoring for Controlled Facilitates and educating Analysts on matters directly related to lab operation and testing.

The QC Micro Laboratory Supervisor is part of the Quality Assurance Department at Ridgefield, NJ. This role is responsible for providing direction and managing the Micro Team of Quality Professionals whose objectives are to ensure product testing, release EM Monitoring and continued process control. When needed, Micro testing will be required.

HOURS: Monday - Friday from 10:00 am to 6:30 pm. Some flex in the start and end times may be allowed, weekend work and overtime as required.

• Knowledge of USP, EU and ISO regulations a must. 

• The candidate must have previous quality control microbiology experience in bioburden testing, membrane filtration, sterility isolator testing, conductivity, total organic carbon, endotoxin assays

• Knowledge of aseptic manufacturing environmental monitoring of Grade A-D Areas.

• Coordination of trending EM data and data analysis,

• Validation protocol writing

• SOP review, creation and approval

• OOS investigations writing/review and approval. 

• Microbial testing or sampling when analysts are out or when required

• Create assignment schedules and ensure all lab support functions are completed according to procedures in a timely fashion. 

• Ensure compliance with all cGMP standards, safety and environmental regulations and company SOPs. 

• Maintain lab supplies, including maintaining a budget, conducting inventories, contacting vendors and initiating purchase requisitions.

• Provide direction to subordinates based on general policies and management guidance. 

• Ensure that projects are completed on schedule and within budget. 

• Data review of EM sampling, LIMS, logbooks, and other miscellaneous lab data. 

• Author and deliver performance reviews to all subordinates. 

• Participates in Change Control meetings as the Microbiology Subject Matter Expert and initiates change controls as required.  

• Provides input to or develops facility related validation protocols for environmental monitoring requirements for new environmentally controlled process rooms or when significant changes are made to existing controlled processing rooms.

• Support regulatory, third party and internal audits

• Conveys complex information in a concise manner

• Ensure team effectiveness and efficiency by setting clear goals and providing timely feedback

• Motivate and Develop teams

• Interact with Project Teams and cross-functional groups related to site operations

Leadership Qualifications:

The QC Micro Laboratory Supervisor is expected to act on and demonstrate the Sanofi LEAD competencies:

• Act for Change: Embrace change and innovation and initiate new and improved ways of working.

• Cooperate transversally: Collaborate effectively with peers, stakeholders and partners across the organization to positively impact business results.

• Develop People: Take responsibility for developing one’s self and other Micro Personnel in anticipation of future business needs.

Job Requirements:

Physical Requirements include the capacity to lift and carry up to 20 pounds, kneel, reach and stretch, and to stand for at least 4 hours.

Education & Experience:

• BA/BS in Microbiology/Biology with 4-7 year experience is required.

• A thorough understanding of the functions required to manage a staff of microbiologists performing general testing as well as aseptic production environmental monitoring.

• Practical experience in general microbiology laboratory techniques working with bacteria, yeast and mold.

• Prior experience with validation testing, writing protocols, data review, authoring SOPS, Change Controls, out of specification investigations and report writing. 

• Working knowledge of cGMPs in pharmaceuticals/biological/aseptic/medical device manufacturing

• Excellent technical writing skills

• Ability to collaborate effectively

• Strong analytical and problem solving skills

• Make sound judgement from data

• Strong communicator

• Works independently

• Working knowledge of Word, Excel and PowerPoint

• Preferred experience with a deviation/CAPA enterprise system

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.