Overview

Replimune is a fast-paced growing innovative company that is in the process of bringing on-line a new production facility purposefully designed to manufacture our Oncolytic Immunotherapies. This multi-product facility in Framingham contains cGMP manufacturing suites and Quality Control testing laboratories. Working in collaboration with cross functional teams, the Principal Microbiologist, QC will be responsible for setting up and maintaining QC Microbiology programs. The Principal Microbiologist will be responsible for establishing procedures to support environmental monitoring and utilities testing (water, gas and air supplies). The Principal Microbiologist will be responsible for overseeing the Contamination Control Strategy, Environmental Monitoring Risk Assessment, and studies regarding Microbiological Assays (Bioburden, Endotoxin, Sterility).

This position is based in our Framingham location and typically has a 5-day on-site expectation.

Responsibilities

The responsibilities of the Principal Microbiologist, QC include, but are not limited, to the following:· Setting up and maintaining of the QC Microbiology systemsneeded to enable testing requirements in support of the facility.· Establishing and overseeing the environmental, water and gas monitoring program, including environmental qualification of the clean room suites.· Oversee the environmental monitoring program including aseptic fill finish (Grade A/B) monitoring. Play a leading role in any excursions and assessing the impact.· Continually develop the environmental monitoring program in line with regulatory requirements and industry guidance. Develop robust procedures to monitor and proactivelyidentify any trends.· Play a leading role in the development of the contamination control strategy.· Management and performance of routine QC testing such as bioburden, endotoxin, B&F testing, growth promotion, Gram stain, microbial ID analysis and raw materials testing.· Management/planning of water sampling and associated water testing

• Ensure completion of change control and deviations related to QC Microbiology operations including assisting with laboratory and OOS investigations.· Author QC regulatory documentation and assist in regulatory audits/inspections, as needed.· Troubleshooting of equipment and QC methods.· Manage / perform assay qualification, as necessary.· Manage Microbiology related technical studies performed with external companies and review of reports.

Qualifications

Experience and skill requirements:

· Minimum 10 years GLP/GMP laboratory-based experience in a Microbiology testing capacity in a GMP-Regulated environment.

• Good analytical skills and technical experience is a must, preferentially with previous experience setting up a testing laboratory and/or supporting a manufacturing facility.· Computer literacy (including MS Word and Excel)
• Ability to work well with others· Effective communication skills· Good organizational skills
• Experience in PAI, agency regulated Audits preferred

Location: 

This position is based in our Framingham location and typically has a 5-day on-site expectation.