The Sr. Associate, Quality Systems,  provides cross-functional support of GXP activities as they relate to Quality Systems. This position will participate in the improvement of Quality Systems to ensure quality and adherence with current Good Manufacturing Practice (cGMP) and inspection readiness.   This position is based in our Framingham, MA facility, and has a 4-5 day in office requiremet per week.

Replimune is a fast-paced growing innovative company that is in the process of bringing on-linea new production facility purposefully designed to manufacture our Oncolytic Immunotherapies.This multi-product facility in Framingham contains cGMP manufacturing suites and QualityControl testing laboratories. Working in collaboration with cross functional teams, the Principal Microbiologist, QC will be responsible for setting up and maintaining QCMicrobiology programs. The Principal Microbiologist will be responsible for establishing procedures to support environmental monitoringand 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.

The Associate Director, Plant Quality Assurance (PQA) is responsible for the development, implementation and maintenance of Quality Assurance systems and activities at Replimune, with a focus on GMP production. Ensures all relevant quality and regulatory requirements are met for product manufacture and testing. Ensures site compliance with quality system regulations issued by FDA, MHRA and other applicable regulatory bodies where Replimune clinical or commercial products are in use. Responsible for the evaluation and assurance that the validation of the aseptic qualification (media fill) program is maintained. Develops and manages the QA staff performing batch review, aseptic process monitoring and other compliance functions.   This position is based in our Framingham location and typically has a 5-day on-site expectation.

The Sr. Manager, Quality Control has the responsibility of managing and overseeing work of direct reports, managing individuals or a team, leading method transfer and validation activities, stability study coordination, management of external testing, write and approve CoAs, assay control, reference material and sample management, writing, reviewing and approving various QC related documents as required. This role also requires performing QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP) as required, setting up and maintaining systems and processes for QC Laboratory, scheduling, review and approval of tests results, management of the QC laboratory and interactions with other groups.   This position is based in Milton Park, and has a 5 day on site expectation.

We imagine a world where cancer is a curable disease.   Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response. Replimune is pioneering the development of novel tumor-directed oncolytic immunotherapies.    Our Talent Community is a great way to stay connected, learn more about Replimune and our career opportunities as well as to receive updates that may interest you!     Thank you for joining!