Associate Director, Process Development

Replimune; United Kingdom; Remote; GBP 115,000 - 150,000; Full time

Job summary

Replimune is seeking an Associate Director - Process Development for its Milton Park, UK site. The role leads the Process Development group, ensuring experiments align with GMP and quality standards and supporting material generation for QC and toxicology studies.

The position emphasizes leadership, collaboration with US PD teams, comprehensive documentation, and driving improvements in cGMP steps. On-site work is expected with occasional travel.

Qualifications

• Minimum 10 years' experience in biologics process development or manufacturing.
• Strong knowledge of current regulatory requirements and cGMP operations.
• Proven leadership and ability to motivate team members to achieve goals.
• Excellent verbal and written communication skills.

Responsibilities

• Lead the Process Development group at Milton Park, UK.
• Ensure lab work is executed per SOPs, protocols and batch records safely and efficiently.
• Produce material for QC/AD assay controls and preclinical/toxicology studies.
• Author/review reports, protocols, SOPs, batch records, etc.
• Drive continuous improvement in cGMP process steps based on findings.
• Maintain timely creation, completion and archiving of records and technical reports.
• Ensure high-quality documentation in laboratory notebooks.
• Represent PD in cross-functional site leadership/administrative meetings.
• Support audits of Milton Park facility and provide updates to senior management.
• Keep up to date with technologies and trends in biologics processing.
• Some travel may be required domestically and internationally.

Skills

Leadership

Biologics PD

cGMP compliance

Technical writing

Cross-functional liaison

Education

Bachelor's degree in a relevant field

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.