Associate Director, Process Development - Biologics (cGMP)

Replimune; Montreal; On-site; CAD 226,000 - 302,000; Full time

Job summary

Replimune is seeking an Associate Director - Process Development to lead the Milton Park-based Process Development group, collaborating with US teams to optimize cGMP production and generate materials for QC and studies. The role requires robust leadership, planning, and documentation to ensure compliant, efficient work and successful tech transfer.

The position typically requires on-site work five days a week at Milton Park, with opportunities to influence process improvements and

Qualifications

• Bachelor’s degree in applicable field; advanced degree preferred.
• Minimum 10 years’ experience (BS) or 6–8 years (MS/PhD) in biologics process development or manufacturing.
• Strong understanding of regulatory requirements and cGMP operations.

Responsibilities

• Lead the Process Development group at Replimune’s Milton Park facility, UK.
• Ensure lab work follows SOPs, protocols and batch records.
• Produce materials for QC/assay controls and toxicology studies.
• Author/reviewer of reports, protocols, SOPs, batch records.
• Drive continuous improvement in cGMP processes through experimental findings.
• Oversee documentation and technology transfer activities for production processes.

Skills

Leadership

Communication

Regulatory knowledge

cGMP

Biologics process development

Team management

Cross-functional collaboration

Education

Bachelor’s degree in applicable field

MS/PhD preferred

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

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,

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.