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. 

 At Replimune, 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, and when it comes to our employees, we make it personal.  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 the meaningful work we do which could impact the lives of patients.  

 Join us, as we reshape the future. 

Job Summary: 

The Associate Director, Planning and Technical Delivery, is responsible for leading the Milton Park Site planning process, coordinating stakeholders to schedule and deliver the QC batch release, stability testing and supporting studies required to meet the site objectives. Reporting to the Milton Park Site Head, the role incorporates coordination and a direct contribution within the cGMP system for monitoring, reporting, issue escalation and resolution related to direct testing and associated supporting projects.

Focusing strongly on delivery, the role will drive the local tiered meeting / operating system and associated reporting / escalation. Working closely with Quality Assurance, Supply Chain and the Portfolio Strategy Team, the Associate Director Planning and Technical Delivery will represent Milton Park on cross-site project teams, coordinating local activities for future business projects as we further enhance the operating systems and capabilities of the business. This position will be located onsite in Milton Park, UK and require essential full-time attendance on site. Flexibility to travel for business is required.

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

Key responsibilities:

• Administration of the Milton Park Site process and tools for planning, scheduling and reporting for all QC testing and batch release activities
• Assisting with the processing, tracking, and trending of testing activities, ensuring coordinated communications with associated stakeholders
• Lead the Milton Park tiered meeting operating system ensuring escalations, metrics and feedback are provided to business leads and associated stakeholders

• Support and/or lead deployment of new equipment, working systems or technology as part of continuous improvement to existing systems or build out of future capabilities

• Prepare project proposals, associated charters, project plans, benefit analysis and CAPEX proposals for approval.
• Drive live projects providing administrative support along with routine periodic progress reports
• Directly contribute to the Technical GMP project delivery, raising CCR’s, authoring or approving associated reports and GMP documentation.
• As required, provide support to Quality Management Systems related activities (audits, investigations, deviations, CAPAs, etc.).

 Other responsibilities

• General support of all operations activities as needed.

Educational requirements:

• A or B.Sc. degree in a relevant biological science and extended relevant commercial experience.

Experience and skill requirement:

• Minimum 8 years’ experience in a cGMP Quality environment and 2-4 years in a managerial role; or equivalent combination of education and experience.
• Practical experience of QC testing in support of cGMP operations for clinical or commercial manufacturing (ATMP preferred).
• Excellent documentation and communication skills with a high attention to detail, enabling an effective interface with management and across the site with project teams and analysts.
• Experienced in project delivery within a GMP environment.
• Ability to work effectively in a fast-paced, regulated environment and manage multiple priorities.
• Must possess excellent knowledge of standard Microsoft Office programs such as Smartsheets.