Jobs at Replimune

Perform GMP-compliant analytical QC testing and review for raw materials, in-process samples, drug substances, and final products. Maintain laboratory systems, procedures, equipment, documentation, and regulatory inventories. Manage deviations, CAPAs, change controls, OOS/OOT investigations, method qualifications, and equipment validation. Support audits and inspections, coordinate external testing, troubleshoot methods and equipment, train junior staff, and collaborate across functions and with vendors.

Supports pharmaceutical manufacturing operations by setting up, operating, changing over, and cleaning equipment under cGMP and SOP requirements. Documents production activities, visually inspects and packages drug product vials, identifies process deviations, handles hazardous materials, maintains waste and flammables areas, and uses computer-based systems for timekeeping, email, and inventory management. This is an onsite second-shift role requiring lifting up to 35 pounds and extended standing.

Executes cGMP biopharmaceutical manufacturing operations, including aseptic processing, buffer preparation, equipment assembly, cleaning, autoclaving, filtration, chromatography, and aseptic filling. Maintains inventory, training, SOPs, batch records, deviations, and manufacturing documentation. Supports visual inspection, equipment validation, commissioning, and maintenance while following safety, quality, and cGMP requirements. Occasional weekend or holiday work may be required based on production schedules.

Supports biologics manufacturing through materials subject-matter expertise, technical risk assessments, change control and deviation evaluation, material trending, process characterization, validation, troubleshooting, and continuous improvement. Evaluates single-use materials, extractables and leachables, and alternative process technologies. Collaborates with manufacturing, QC, regulatory, and cross-functional teams, contributes to commercial production readiness and regulatory filings, and represents technical operations during audits.

Leads administration, governance, optimization, validation, and continuous improvement of electronic Quality Management Systems, primarily Veeva Quality and MasterControl. Supports GxP compliance, regulatory inspections, audits, documentation, quality metrics, workflows, user access, reporting, system implementations, and lifecycle management. Serves as a Quality Systems subject matter expert, manages vendors, advises cross-functional stakeholders, and independently drives remediation and process improvement initiatives across multiple sites.

Supports the Quality Assurance department in maintaining GMP compliance and the Quality Management System. Responsibilities include batch release, inspection and audit readiness, deviation and CAPA investigations, change control, QMS metrics, vendor qualification, supplier corrective actions, and review or approval of SOPs, validation documents, production records, testing records, and other GMP documentation. The role collaborates with Quality Control, Regulatory, Clinical, Product Development, and external vendors to support compliance and commercial readiness.

Lead development and oversight of quality assurance systems for clinical and post-market pharmacovigilance and medical affairs. Ensure GCP/GVP compliance, inspection readiness, vendor oversight, regulatory interactions, KPI/KQI metrics, training, risk-based quality strategies, and cross-functional process improvement to protect patient safety and data integrity.

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 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.

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.