Associate Director, Process Development

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.

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 of production processes; Ensure effective, high-quality, timely and appropriate documentation in laboratory notebooks; 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

Requirements

Bachelor's degree in applicable field; 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

Nice to have

Advanced degree