Senior Quality Control Analyst

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.

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we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

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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. The Senior Quality Control (QC) Microbiology Analyst will be responsible for the performance of the routine QC sampling and testing within the function of the Quality Control (QC) Microbiology Laboratory.

Additionally, the Senior QC Microbiology Analyst will assist in setting up and maintaining the QC Microbiology laboratories, scheduling the routine QC Microbiology testing and oversee the performance of non-routine / investigational testing performed within the Microbiology Laboratories. It is expected that the Senior QC Microbiology Analyst maintains GMP compliance in the QC Microbiology laboratory. This position is based at the Replimune Framingham facility.

The responsibilities of the Senior QC Microbiology Analyst include, but are not limited, to the following:

• Setting up and maintaining of the QC microbiology laboratories and systems needed to enable testing requirements in support of the facility.
• Assist in scheduling and oversight of environmental monitoring testing performed in QC Microbiology laboratories.
• Execute the environmental, water and gas monitoring program, including environmental qualification of the clean room suites.
• Perform routine QC Microbiology sampling and testing such as bioburden, endotoxin, growth promotion, Gram stain, and microbial identifications.
• Perform water sampling and associated water testing (such as chemical analysis to include visual appearance, heavy metals, nitrates, pH, conductivity, etc.).
• Sampling and testing of gas supplies to manufacturing suites.
• Trend environmental monitoring data and compile trend reports.
• Write and revise SOPs, protocols and technical reports as necessary.
• Coordinate shipment of samples to contract testing laboratories and review of testing data reports.
• Review testing data of other QC Analysts, as applicable.
• Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory and ordering of supplies, etc.
• Maintain QC Microbiology related systems in compliance with industry standards.

• Act as deputy for the QC Manager with regards to QC Microbiology matters (in absence of QC Manager, Microbiology).
• Represent QC at inter-departmental meetings and interact with external vendors as necessary.
• Raise change control and deviations related to QC Microbiology operations including assisting with laboratory and OOS investigations.
• Assist in regulatory audits/inspections, as needed.
• Troubleshooting of equipment and QC methods.
• Train other QC Analysts within scope of knowledge.

• BA or BS in Microbiology…