Head of Process Development, Biologics

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

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.