Senior Director, Biologics Process Development

Replimune; Abingdon; On-site; GBP 90,000 - 130,000; Full time

Job summary

Replimune is seeking an Associate Director of Process Development to lead the Milton Park team in the UK. The role focuses on characterizing and improving cGMP production steps while producing materials for assay controls and studies.

You will collaborate with US colleagues to ensure efficient bench-scale experiments and compliant reporting. The position is based on-site at Milton Park with a typical 5-day on-site expectation.

Qualifications

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

Responsibilities

• Lead the Process Development group at Milton Park, UK.
• Ensure lab work follows SOPs and batch records safely and efficiently.
• Produce material for QC/AD assay controls, preclinical and toxicology studies.
• Author and review reports, protocols, SOPs and batch records.
• Drive continuous improvement in cGMP steps from experimental findings.
• Maintain timely creation, completion and archiving of records and reports.
• Represent PD in cross-functional site leadership and audits.
• Promote safe work habits and adherence to safety guidelines.
• Provide regular updates of Milton Park PD activities to senior management.
• Stay current with technologies and trends in biologics processing.
• Some travel may be required, domestically or internationally.

Skills

Leadership

Process Development

cGMP

Regulatory knowledge

Education

Bachelor's degree required

Advanced degree preferred

Job description

Replimune is seeking an Associate Director of Process Development to lead the Milton Park team in the UK. The role focuses on characterizing and improving cGMP production steps while producing materials for assay controls and studies.

You will collaborate with US colleagues to ensure efficient bench-scale experiments and compliant reporting. The position is based on-site at Milton Park with a typical 5-day on-site expectation.