Jobs at Replimune

Lead and oversee aseptic drug product manufacturing at a new cGMP facility, ensuring sterile operations, contamination control, environmental monitoring, batch record management, CAPA/investigation support, equipment maintenance, technology deployment, staff hiring and development, and regulatory interactions to achieve commercial readiness and compliance.

Perform cGMP/GLP QC analytical testing of raw materials, in-process, drug substance and final product per SOPs. Maintain QC systems, review data, support method qualifications, investigations (OOS/OOT), CAPA/change control, equipment validation, sample management, and training. Support audits, regulatory inspections, vendor interactions, and coordination with external testing labs to ensure GMP compliance.

Support and maintain GxP-aligned Quality Systems for multiple sites: manage controlled documents and archival, administer MasterControl and Veeva, handle Jira document requests, create training items, support audits, generate QMS metrics, and drive continuous improvement to ensure cGMP compliance and inspection readiness.

Execute packaging and serialization activities for finished drug product in a GMP environment, including equipment setup/operation, line clearance, documentation of batch records, in-process quality checks, visual vial and carton inspection, handling ultra-low temperature materials, and collaborating with Quality and supply chain to ensure compliance and product safety.

Support and lead GMP batch release and product disposition for drug substance and drug product across internal and external CMOs and 3PLs. Review batch records, CoAs, packaging/labeling, manage OOS/deviations/CAPA and product complaints, ensure inspection readiness, train and mentor QA staff, provide QA subject-matter support for audits, and drive continuous improvement of quality systems.

Execute packaging and serialization of finished drug product following cGMP/GDP and SOPs. Operate and maintain packaging equipment, perform in-process and visual quality checks, complete batch documentation, handle ultra-low temperature materials, support material movement and inventory, escalate quality or equipment issues, and participate in continuous improvement and safety practices.

Provide engineering support and ownership for GMP and non‑GMP utilities and equipment (WFI, Pure Steam, PW, process gases, HVAC, manufacturing and lab equipment). Lead troubleshooting, root‑cause investigations, corrective/preventive actions, change controls, validation, commissioning, and project installation while ensuring cGMP, SOP, OSHA and quality compliance.

Provide on-floor QA support during second shift to ensure cGMP/GDP compliance; review batch records, lab documentation, and quality records; manage deviations, CAPAs, and change controls; author and revise quality system documents; support investigations, audits, training, and continuous improvement initiatives.

Lead CMC data science activities including GMP process monitoring (CPV), statistical analysis, DOE design, creation of CMC data repositories, embedding ML/AI into CMC workflows, visualizing risks, driving continuous improvement, and managing a data science team to support commercial production readiness.