Process Support Lead, GMP Biopharma Manufacturing

RoslinCT EU; City of Edinburgh; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

31 days annual leave

Group Pension scheme

Group Life Cover

Private healthcare

Cycle2Work scheme

Flexible benefits

Job summary

RoslinCT in Edinburgh BioQuarter is seeking a Process Support Team Lead to oversee the Commercial Manufacturing Process Support team. You will prioritise activities to align with schedules, drive readiness, and ensure robust documentation and change control for manufacturing.

You will lead investigations, CAPA and continuous improvement efforts while maintaining strong stakeholder relationships across functions and ensuring compliance with GMP and aseptic manufacturing standards.

Qualifications

• Minimal 5 years’ experience within GMP-regulated biopharmaceutical, cell therapy, gene therapy or ATMP manufacturing environments.
• Proven experience leading, managing and developing teams while delivering operational objectives.
• Competent in typical Grade B cleanroom roles with ability to lead troubleshooting activities.
• Strong understanding of GMP requirements, quality systems and aseptic manufacturing principles.
• Demonstrated knowledge of routine end to end processing & leading investigations, root cause analysis and CAPA implementation.
• Excellent stakeholder management skills, with the ability to influence across multiple functions.

Responsibilities

• Lead, manage and develop the Process Support team, prioritising activities to manufacturing schedules, priorities and business objectives.
• Coordinate manufacturing readiness activities and assessments to support successful manufacturing execution.
• Ensure manufacturing documentation is maintained and updated, including batch record changes.
• Act as key contact for process escalation and manufacturing support during issue resolution and stabilisation.
• Lead CAPA implementations, deviations investigations and root cause analysis.
• Drive visual management tool adoption and keep operational systems current and effective across manufacturing.

Skills

Leadership

GMP knowledge

Quality systems

Aseptic manufacturing

Stakeholder management

Education

Life Science degree

Job description

RoslinCT in Edinburgh BioQuarter is seeking a Process Support Team Lead to oversee the Commercial Manufacturing Process Support team. You will prioritise activities to align with schedules, drive readiness, and ensure robust documentation and change control for manufacturing.

You will lead investigations, CAPA and continuous improvement efforts while maintaining strong stakeholder relationships across functions and ensuring compliance with GMP and aseptic manufacturing standards.