Manager, CMC Process Development

Manager, CMC Process Development

Location:

Manchester (Fully Site‑Based)

Hours:

7:00am – 3:00pm, Mon-Fri

Contract:

Permanent

Reports to:

Head of Validation UK

About the Role

We are seeking an experienced Manager, CMC Process Development 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 at a Manchester site. You’ll work closely with academic and industry 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.

Key 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.

* Act as the primary on‑site technical contact, working independently while reporting into the newly hired Head of Validation UK.

* 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