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 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 QC Microbiology Analyst will assist setting up and maintaining the QC Microbiology laboratories. It is expected that the QC Microbiology Analyst maintains GMP compliance in the QC Microbiology laboratory. This position is based at the Replimune Framingham facility.
Key Responsibilities:The responsibilities of the QC Microbiology Analyst include, but are not limited, to the following:Assist in set up and stocking of the QC microbiology laboratories to enable testing requirements in support of the facility.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.Establish and perform sample management including receipt, inventory and aliquoting.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.Other Responsibilities: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.
Educational Requirements:BA or BS in Microbiology or other related science, preferably with Microbiology modules or coursework as part of the study program.Experience and Skill Requirements:1-3 years of laboratory-based experience in a testing capacity.Knowledge of Microbiology techniques and technical experience, within a Microbiology Lab is preferred.Computer literacy (MS Word and Excel), good communication and organizational skills.Ability to work well independently and with others in a team. *Please note: Candidates must be local or open to relocating as remote is not an option for some roles. Woburn Location: Local candidates are expected to be on-site 2 days per week. Non-local candidates open to 10-25% travel to Woburn officeFramingham Location: Please Note for Framingham roles 5 day onsite expectationReplimune is an equal opportunity employer.Replimune now requires COVID vaccination disclosure for all US employees.