Teams at Replimune

Perform raw material, in-process, final product, and water quality testing in a GMP laboratory. Establish testing methods, manage sampling and external laboratory programs, review data, write SOPs and protocols, support equipment validation and method transfers, investigate deviations, and assist with audits. The role also includes laboratory setup, equipment maintenance, analyst training, inventory management, and cross-functional collaboration. This position is based onsite five days per week in Framingham.

Supports day-to-day PDT laboratory and process activities, including upstream tissue culture, downstream virus purification, drug product formulation, process characterization, and formulation development. Performs laboratory and pilot process steps, equipment setup, sampling, cleaning, reagent preparation, documentation, and laboratory upkeep. Works under GMP procedures and collaborates with manufacturing, quality, facilities, engineering, analytical development, and quality assurance teams.

Supports pharmaceutical Quality Systems and GxP activities by managing controlled documents, records, archival processes, training assignments, document workflows, and quality system metrics. Administers MasterControl and supports Veeva, audits, onboarding training, inspection readiness, and continuous improvement. The role collaborates across departments and maintains compliant, audit-ready documentation under cGMP and GDP requirements.