CMC Manager

RBW Consulting; Woking; On-site; GBP 90,000 - 120,000; Full time

Job summary

RBW Consulting seeks an experienced CMC Manager to guide radiopharma products from early research through scale-up and into GMP manufacturing. This leadership role acts as the site’s expert authority on process development, validation activities, and readiness for GMP production.

You will collaborate with university R&D groups, drive validation activities for new processes and equipment, and support audits while ensuring compliance with GMP and site quality systems.

Qualifications

• Hands-on experience taking products from laboratory research through scale-up.
• Radiopharmaceutical (radiopharma/nuclear medicine) experience is essential in GMP or regulated environments.
• Strong understanding of validation requirements including IQ/OQ/PQ development and execution.

Responsibilities

• Lead process development activities, taking products from the laboratory through scale‑up to full GMP manufacturing.
• Develop, implement, and maintain CMC strategies for new radiopharma products.
• Own all validation activities for new processes and equipment, including IQ/OQ/PQ documentation and execution.
• Collaborate with university R&D groups to integrate discoveries into scalable processes.
• Provide technical expertise during audits by internal and external bodies.
• Ensure compliance with GMP, regulatory standards, and site quality systems.

Skills

Radiopharmaceutical experience

Validation experience

Process development

Job description

CMC Manager

Location: Woking (Fully Site‑Based)
Hours: 7:00am - 3:00pm, Mon-Fri
Contract: Permanent

About the Role

We are seeking an experienced CMC Manager to lead the transition of new pharmaceutical products from early research through scale‑up and into GMP manufacturing. This is a highly specialised, independent role. You\'ll work closely with research teams to translate innovative concepts into validated, compliant manufacturing processes. While this position carries no direct line reports, you will be the site\'s expert authority for process development, validation activities, and technical readiness for GMP manufacture.

Responsibilities

• Lead process development activities, taking products from the laboratory through scale‑up to full GMP manufacturing.
• Develop, implement, and maintain CMC strategies for new radiopharma products.
• Own all validation activities for new processes and equipment, including IQ/OQ/PQ documentation and execution.
• Collaborate closely with scientific teams at the associated university R&D group to integrate new discoveries into scalable processes.
• Provide technical expertise during internal and external audits.
• Ensure compliance with GMP, regulatory standards, and site quality systems.

Essential Experience & Skills

• Hands‑on product‑to‑lab experience, ideally taking products from laboratory research through to scale‑up.
• Radiopharmaceutical (radiopharma/ nuclear medicine) experience is essential—ideally within a GMP or regulated environment.
• Strong understanding and practical experience with validation requirements, including:
• • Equipment qualification
  • Process validation
  • IQ / OQ / PQ development and execution
• Strong communication skills and confidence operating as the site\'s technical process development representative.

Why Join Us?

• Be part of a brand new site directly integrated with cutting‑edge university radiopharma research.
• Play a pivotal role in bringing next‑generation radiopharmaceuticals to patients.
• Work in a specialised, purpose‑driven environment where your technical expertise has immediate impact.
• Join a growing UK organisation with ongoing investment in leadership and validation