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.

Provide QA oversight for GMP manufacturing and testing, perform batch reviews to support product release, maintain and improve quality systems (change control, deviations, CAPA), lead audits and vendor oversight, ensure compliance with MHRA/EMA/FDA, train staff, and manage QA documentation and metrics.

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.

Support day-to-day Quality Assurance operations within a GMP environment: perform batch reviews, assist QMS activities (change control, deviations, CAPA), review and approve SOPs/validation and testing records, conduct root cause analyses, perform compliance walkarounds, track QMS metrics, manage controlled documentation, and liaise with internal teams and external vendors to ensure regulatory compliance.

Lead revenue accounting and Order-to-Cash implementation for the companys first commercial product. Oversee month-end close, SOX control coordination, gross-to-net and inventory accounting, contract review, Oracle reporting, cross-functional collaboration, and ensure US GAAP compliance.

Perform month-end general ledger tasks including journal entries and reconciliations for cash, investments, prepaids, PP&E, accruals, and AP; record cash transactions and FX rates in Oracle Fusion; manage expense reports via Concur; support SOX controls, SEC reporting schedules, audits, and ad hoc finance projects while collaborating cross-functionally.

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.

Lead HCP marketing and launch execution for RP1 in PD‑1 failed melanoma. Develop tactical campaigns, KPIs, and brand plans; manage KOL/advisory boards, agencies, budgets, and cross‑functional partnerships; ensure compliance with healthcare regulations; adapt tactics post‑approval to optimize commercial performance. Hybrid role based in Woburn, MA with ~10–25% travel.

Execute and improve daily HR operations including ADP data maintenance, payroll for exempt and non-exempt staff, onboarding/offboarding, contractor records, employee file audits, HRIS and LMS data administration, and serve as primary HR contact for employees and internal partners to ensure compliance and support.

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.

Provide QA oversight for GMP manufacturing and testing, perform batch review to support Qualified Person release, maintain and improve quality systems (change control, deviations, CAPA), ensure regulatory compliance (MHRA/EMA/FDA), lead audits and vendor QA oversight, deliver training, document control, and quality metrics reporting.

Lead IT operations and cybersecurity strategy for a biotech company, ensuring secure, reliable, and compliant infrastructure. Partner with executives, build and mentor IT/security teams, manage vendor relationships, incident response, business continuity, risk management, and regulatory/GxP audit support to enable research, clinical, manufacturing, and corporate functions.

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.

Support day-to-day Quality Assurance operations in a GMP environment: perform batch reviews, assist Qualified Person release activities, manage QMS processes (change control, deviations, CAPA), review/approve SOPs and validation documents, conduct compliance walkarounds, track QMS metrics, and interface with internal teams and vendors to maintain regulatory compliance.