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Senior Quality Control Microbiologist
2 months ago
Overview
Replimune, Inc. is an innovative and rapidly expanding organization dedicated to the development of Oncolytic Immunotherapies. Our state-of-the-art production facility is designed to meet the rigorous demands of modern manufacturing.
This facility features cGMP manufacturing suites and specialized Quality Control testing laboratories. The Senior Quality Control Microbiologist will play a pivotal role in establishing and maintaining microbiological quality control programs.
Key Responsibilities
The Senior Quality Control Microbiologist will be tasked with:
- Developing and maintaining the necessary QC Microbiology systems to support testing requirements.
- Establishing and supervising the environmental, water, and gas monitoring programs, including the qualification of clean room environments.
- Overseeing the environmental monitoring program, particularly in aseptic fill finish areas, and leading investigations into any deviations.
- Continuously enhancing the environmental monitoring program in accordance with regulatory standards and industry best practices.
- Leading the development of a comprehensive contamination control strategy.
- Managing routine QC testing activities, including bioburden, endotoxin, and microbial identification.
- Coordinating water sampling and testing protocols.
- Ensuring compliance with change control and deviation procedures related to QC Microbiology operations.
- Authoring regulatory documentation and supporting audit processes as required.
- Troubleshooting QC methods and equipment.
- Overseeing assay qualifications and managing technical studies conducted with external partners.
Qualifications
The ideal candidate will possess:
- A minimum of 10 years of GLP/GMP laboratory experience in a microbiological testing role within a regulated environment.
- Strong analytical skills and technical expertise, ideally with experience in laboratory setup and manufacturing support.
- Proficiency in computer applications, including MS Word and Excel.
- Excellent interpersonal and communication skills.
- Strong organizational abilities.
- Experience with regulatory audits and inspections is preferred.
This role requires a commitment to maintaining high standards of quality and compliance within our operations.
