Jobs at Replimune

Performs routine and non-routine pharmaceutical QC testing, cell culture, sample and inventory management, equipment maintenance, method transfers, validation, stability activities, and GMP documentation. The role also supports deviations, CAPA, change controls, OOS/OOT investigations, audits, inspections, SOP updates, and team training. This is a predominantly on-site laboratory position at Milton Park.

Performs routine QC testing under SOPs, maintains cell lines, reviews data, manages samples and inventory, maintains equipment, and writes or updates QC documentation. Supports method transfers, qualification, stability activities, investigations, audits, and regulatory inspections while following cGMP and GDP requirements.

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.

Leads clinical development strategy and execution for oncology programs, overseeing study design, conduct, analysis, interpretation, and regulatory documentation. Partners cross-functionally with clinical operations, safety, regulatory, biometrics, and research teams, as well as CROs and investigators. Provides medical and scientific support, manages clinical data and trial communications, develops investigator networks, supports budgets and SOPs, and contributes to global drug development and registration activities.

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.

Leads commercial IT strategy and CRM operations, including Veeva and Salesforce configuration, marketing technology integrations, Oracle data warehousing, master data management, field technology, privacy compliance, vendor oversight, and software deployments. Partners with marketing, sales, market access, medical, and IT teams while managing commercial technology projects and web platforms.

Supports pharmacovigilance activities for developmental and marketed products, including safety data analysis, signal detection, risk management, aggregate safety reporting, literature surveillance, case review, regulatory responses, and inspection-ready documentation. Collaborates with clinical, regulatory, medical affairs, biostatistics, and safety teams; supports MedDRA and WHO Drug coding, ARGUS reporting, SOP development, and BLA/MAA-related activities while ensuring compliance with global PV regulations.

Performs routine PCR, ELISA, chromatography, and cell-based testing for Analytical Development, Process Development, Research, and Quality Control projects. Supports analytical method development and product characterization, prepares reagents and assay controls, maintains and calibrates laboratory equipment, manages consumables, reviews GMP documentation, updates SOPs, and trains team members. The role is primarily laboratory-based and onsite five days per week.

Performs routine PCR, ELISA, chromatography, and cell-based testing for analytical development, process development, research, and QC projects. Supports analytical method development and product characterization, prepares reagents and assay standards, maintains and calibrates laboratory equipment, manages consumables, reviews GMP documentation, updates SOPs, and trains team members. The role is primarily laboratory-based and requires adherence to GMP, safety, and quality procedures.

Performs analytical testing supporting process development, research, quality control, and analytical development. Responsibilities include PCR, ELISA, chromatography, and cell-based assays; method development, qualification, validation, characterization, and technology transfer; reagent preparation; data analysis; equipment maintenance; GMP documentation; SOP and report writing; and team training.

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.

Leads clinical development execution for oncology programs, including protocol and regulatory document development, clinical study design and conduct, data review, site and vendor support, medical monitoring partnership, trial presentations, KOL engagement, and cross-functional collaboration. Ensures compliance, manages timelines and goals, supports SOP development, and contributes to therapeutic research and competitor analysis.

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.

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.

Leads regional Medical Science Liaison operations, including recruiting, training, coaching, performance management, resource allocation, compliance, and strategic execution. Partners with Medical Affairs and cross-functional leadership to support clinical and business objectives, analyze therapeutic-area needs, engage thought leaders, and communicate regional results. Maintains scientific and competitive expertise while ensuring accurate documentation, regulatory adherence, and effective field deployment.

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.

Leads market access, pricing, contracting, patient support, payer marketing, reimbursement, and value strategies for pharmaceutical brands across US and international markets. Oversees launch planning, pricing and revenue optimization, payer engagement, coding initiatives, patient services, market research, compliance, budgeting, and a team of market access leaders. Partners with Finance, Medical, HEOR, Brand, and Commercial teams to maximize product access, profitability, and lifecycle performance.