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Added 13 mins ago
BC
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Replimune

Associate Director, Process Development

Montreal, QC, Canada

Full-time

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Job details

Job type: Full-time
Apply by: Nov 6, 2026
Experience: A minimum of 10 years’ experience (BS) or 6 to 8 years (MS/PhD) in biologics process development or manufacturing
Posting language: English
Posted: Oct 7, 2026

Original job description

Overview

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.

At Replimune, We Live By Our Values

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Summary Of Job Description

The Associate Director - Process Development is responsible for managing the Process Development team at Replimune’ s Milton Park facility. The Process Development team at the Milton Park facility collaborates with their PD colleagues in the US to characterize and improve process steps within the cGMP production processes by executing robust bench scale process experiments. The Process Development team at Milton Park is also responsible for the generation of materials to support other departments/studies (assay controls, assay buffers, preclinical / tox material, etc.). The Associate Director will ensure that all work is planned, performed, and reported in an efficient and compliant manner.

This position is based in our Milton Park location and typically has a 5-day on-site expectation.

Key Responsibilities

Leading the Process Development group at Replimune’s Milton Park facility, UK.
Ensuring lab work is executed as per experimental design instructions (SOP, protocol, batch record, etc.) in a safe and efficient manner.
Production of suitable material for QC / AD assay controls, preclinical and toxicology studies, etc.
Author / reviewer of reports, protocols, SOPs, batch records, etc.
Drive continuous improvement in our cGMP process steps through application of experimental findings.
Supervises timely creation, completion and archiving records, protocols and technical reports to document the development, characterization and technology transfer pf production processes.
Ensure effective, high-quality, timely and appropriate documentation in laboratory notebooks.

Other Responsibilities

Milton Park PD representative for cross-functional site leadership / administrative meetings.
Practices and promotes safe work habits and adheres to safety procedures and guidelines
PD representative for audits of Milton Park facility.
Provide regular updates of Milton Park PD group activities to senior management.
Keeps up to date with current technologies and trends in biologics processing
Some travel may be required, both in country and international.

Educational Requirements

Bachelor’s degree in applicable field with advanced degree preferred.

Experience And Skill Requirement

A minimum of 10 years’ experience (BS) or 6 to 8 years (MS/PhD) in biologics process development or manufacturing
Thorough understanding of current regulatory requirements and practical experience in support of cGMP operations
Proven leadership in managing and motivating team members to achieve goals
Ability to interface effectively with management and other groups or project teams

Excellent verbal and written communication skills

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.

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More about this job

Responsibilities

Lead the Process Development group at the Milton Park facility, overseeing safe, efficient, compliant laboratory work and production of materials for quality control, assay, preclinical, and toxicology needs. Drive cGMP process improvements and ensure development, characterization, and technology-transfer work is documented, reported, and archived appropriately.

Requirements

Requires at least 10 years of relevant experience with a bachelor’s degree, or 6–8 years with a master’s or PhD, in biologics process development or manufacturing. Candidates should have a strong understanding of regulatory requirements and cGMP operations, proven team leadership, and effective communication and collaboration skills.

Skills

Process Development
Biologics Processing
cGMP Operations
Team Leadership
Process Characterization
Process Improvement
Experimental Design
Technical Documentation
Protocol and SOP Authoring
Batch Record Management
Technology Transfer
Regulatory Compliance
Laboratory Safety
Cross-Functional Collaboration
Written and Verbal Communication

Visa sponsorship

Not detected in the job text

Keywords

Biologics
Process Development
cGMP
Manufacturing
Regulatory Requirements
Process Characterization
Process Improvement
Bench-Scale Experiments
Experimental Design
Quality Control
Assay Controls
Preclinical Materials
Toxicology Materials
Standard Operating Procedures
Protocols
Batch Records
Technical Reports
Laboratory Notebooks
Technology Transfer
Audits
Laboratory Safety
Oncolytic Immunotherapies
HSV-1
RPx Platform

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