Senior Microbiologist

Responsibilities:

• Basic knowledge of aseptic manufacturing environmental monitoring of Grade A-D Areas.
• Validation protocol writing, review, and execution (or overseeing validation execution).
• SOP review, creation, and approval.
• OOS investigations writing/review and approval.
• Mentor junior Analysts on testing, troubleshooting, and lab-related items.
• Ensure compliance with all cGMP standards, safety and environmental regulations, and company SOPs.
• Provide advice to subordinates based on general policies and management guidance.
• Ensure that high-level projects are completed on schedule and accurately.
• Data review of EM sampling, LIMS, logbooks, and other miscellaneous lab data.
• Participates in Change Control meetings as the Microbiology Subject Matter Expert and initiates change controls as required.
• Support regulatory, third-party, and internal audits when required.
• Conveys complex information in a concise manner.
• Motivate and develop teams.
• Interact with Project Teams and cross-functional groups related to site operations.
• The candidate must have previous quality control microbiology experience in bioburden testing, membrane filtration, sterility isolator testing, conductivity, total organic carbon, and endotoxin assays.

• 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 oneself and mentor other Micro Personnel in anticipation of future business needs or to assist the micro department.
• HSE: Individuals must care for their own safety and well-being and promote a safe working environment for employees and contractors in their area of responsibility.
• Support all Sanofi and site HSE policies and ensure that work performed is compliant with local HSE regulations.
• Complete all required HSE training and report all accidents and incidents, supporting investigations in their areas of responsibility.
• Physical Requirements: Capacity to lift and carry up to 20 pounds, kneel, reach, stretch, and stand for at least 4 hours.
• BA/BS in Microbiology/Biology with 6-10 years' experience is required.
• Thorough understanding of validation testing; write, execute, and report validation studies.
• Practical experience in general microbiology laboratory techniques working with bacteria, yeast, and mold.
• Prior experience with writing protocols, data review, authoring SOPs, Change Controls, out of specification investigations, and report writing.
• Excellent technical writing skills.
• Ability to collaborate effectively with personnel and between departments.
• Strong analytical and problem-solving skills.
• Make sound judgments from data and work independently.
• Working knowledge of Word, Excel, and PowerPoint.
• Preferred experience with a deviation/CAPA enterprise system.