Scientist , QC Analytical

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Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full‑body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. We imagine a world where cancer is a curable disease.

We live by our values:
United – We Collaborate for a Common Goal. Audacious – We Are Bold and Innovative. Dedicated – We Give Our Full Commitment. Candid – We Are Honest With Each Other.

People are at the center of everything we do. With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward‑looking total rewards program, everyone at Replimune has a unique opportunity to contribute to work that could impact patients’ lives.

The Scientist I/II, QC Analytical will perform QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). The role may also include overseeing junior QC staff and training new analysts. The scientist will assist with maintaining QC systems, scheduling, performing and reviewing tests of raw materials, in‑process, drug substance and final drug product samples, and manage the QC laboratory to maintain GMP compliance.

This position is based at our Framingham location and typically requires a 5‑day on‑site presence.

• Establish, revise, and maintain procedures for QC analytical testing.
• Maintain QC systems for raw materials, in‑process, drug substance and final drug product sample testing.
• Review testing data of other analysts.
• Assist with maintenance of QC laboratory and equipment.
• Generate protocol and reports for method qualifications.
• Perform QC analytical testing following SOPs.
• Document results in accordance with cGMP.
• Manage change control, deviations and CAPAs, including OOS, OOT investigations.
• Assist with audits and regulatory inspections.
• Validate QC laboratory equipment.
• Communicate QC analytical requirements internally and across functional groups.
• Oversee sampling, storage of QC samples and maintain regulatory/retention inventory.
• Coordinate shipping of samples to contract testing laboratories.
• Train others within the department.
• Understand USP/EP monograph testing requirements.

• Troubleshoot equipment and analytical test methods.
• Manage technical studies with external companies and review reports.
• Represent QC at inter‑departmental meetings and interact with external vendors.
• Other tasks as assigned.

• BA or BS in analytical chemistry or related science, preferably with chemistry coursework.

• 5+ years of experience in a GMP/GLP environment.
• Knowledge of analytical techniques and experience in an analytical lab.
• Computer literacy (MS Word and Excel) and strong communication and organizational skills.
• Ability to work independently and in team settings.

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with a mission to transform cancer treatment by pioneering novel oncolytic immunotherapies.

We are an Equal Opportunity Employer.

Base pay range: $ – $, plus performance incentive bonus, new‑hire equity and ongoing equity grants subject to board approval. Comprehensive benefits include medical, dental, vision, 401(k) match, flexible time off, and paid holidays.

Mid‑Senior level

Full‑time

Research, Analyst, and Information Technology