Process Support Team Lead

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

Process Support Team Lead

Location: Edinburgh BioQuarter

Who are we?

We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives. Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

Find out more about what we do here!

Why join us?

• The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
• A generous salary package – we reward our people at the level they deserve.
• 31 days of annual leave, plus 4 public holidays which increases with tenure.
• A competitive company pension scheme to help you save for the future.
• Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind.
• Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
• Flexible benefits such as retail discounts and access to the Cycle2Work scheme.

Your new role

• An exciting opportunity for aProcess Support Team Lead to join our Commercial Manufacturing team.
• You’ll be responsible for leading, managing and developing the Process Support team, ensuring activities are prioritised and aligned to manufacturing schedules, priorities and business objectives.
• Coordinating manufacturing readiness activities and assessments to support successful manufacturing execution.
• Ensuring manufacturing documentation is maintained and ready for use, including batch record updates and implementation of approved document changes.
• Acting as a key point of contact for process escalation and manufacturing support activities, providing leadership during issue resolution and process stabilisation.
• Leading the implementation of CAPAS, approved process and continuous improvement initiatives while supporting deviation investigations and root cause analysis.
• Implementing and championing the use of visual management tools and ensure operational systems remain current and effective across manufacturing.

About you

• Minimal 5 years’ experience within GMP-regulated biopharmaceutical, cell therapy, gene therapy or advanced therapy 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.

Qualifications

• Degree in a Life Science, Biotechnology, Bioprocessing, Biochemical Engineering or related discipline.

At RoslinCT, we’re all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows they’re valued and encouraged to be themselves, whether they’re our employees, customers, or partners. We take pride in being an equal opportunity employer. We treat all applicants fairly and don’t discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms. If you’ve got any specific needs or concerns regarding accessibility during the recruitment process, don’t hesitate to reach out to us at [e-mail]. We’re here to assist and make things as smooth as possible for you.