Jobs at Replimune

Performs QC testing under GLP, GMP, and SOP requirements; maintains laboratory equipment and systems; reviews documentation; authors SOPs and quality records; supports assay transfers, validation, investigations, inspections, and submissions. The role manages samples and reagents, coordinates external testing, trains staff, troubleshoots methods, supports vendors, and may supervise direct reports.

Performs quality control testing under SOP and cGMP requirements, maintains laboratory systems and equipment, reviews documentation, supports assay transfers and validations, and leads investigations. The role also includes SOP authoring, sample and reagent management, regulatory inspection support, equipment qualification, staff training, troubleshooting, vendor coordination, and potential line management. This is a full-time, five-day onsite position in Milton Park.

Provides quality assurance oversight for GMP batch review and drug product release, quality systems, CAPA, deviations, audits, risk assessments, compliance monitoring, controlled documentation, training, and vendor qualification. Partners cross-functionally with Quality, Regulatory, Clinical, Quality Control, Product Development, and external suppliers to maintain compliance with GxP, MHRA, EMA, FDA, and other applicable requirements.

Responsible for Qualified Person batch certification and disposition of clinical and commercial products in the EU and UK. Reviews batch records, quality control data, deviations, investigations, changes, complaints, stability data, supply chains, audits, and regulatory compliance. Ensures GMP adherence, validated processes, appropriate quality systems, technical agreements, training, and distribution arrangements. Leads quality defect activities and supports continual quality improvement.

Provides HR leadership for the UK site, advising senior leaders and employees on employee relations, performance management, talent acquisition, engagement, onboarding, benefits, compliance, and development. Partners with specialist HR teams, supports UK employment processes, leads process improvements and cross-functional initiatives, and helps build a high-growth organization. The role requires at least four days per week onsite in Milton Park, UK, plus 10–15% travel to Boston.

Lead development, qualification, validation and transfer of analytical methods for drug substance and product under ICH and cGMP. Support release, stability, QC, process development, CMC filings, and coordinate CRO/CMO analytics. Troubleshoot methods, supervise assay staff, and provide cross-functional AD representation and regulatory support.