Head of GMP Production

Role Overview

We are currently looking for a Head of GMP Production to join a leading Cell and Gene Therapy company that are currently in the process of designing and building a brand new Manufacturing facility. As the Head of GMP Production you will be responsible for the GMP Manufacturing facility capable of supporting the production of a wide range of Call and Gene Therapies.

You will be responsible for the establishment of the GMP production team and take a lead role in the set-up and operation of the GMP production site.

This is an exciting opportunity to join an established C> Consultancy and Process Development business in the next phase of their develop. You will have the opportunity to help build a team and manufacturing facility from scratch and make you mark by leading the day-to-day management and operations of a brand new GMP facility.

Key Duties and Responsibilities

Your duties as the Head of GMP Production will be varied however the key duties and responsibilities are as follows:

1. Be the named Production manager on the GMP facilitys Manufacturing Authorisation and be responsible for leading the qualification of the facility, equipment and processes from detailed design through to MHRA licensing.

2. Recruit, develop and lead production staff to meet planned production needs and departmental budgets.

3. You will lead and manage of the facility including maintenance, operation, qualification, validation and storage and waste. You will ensure that compliance is maintained and work closely with the Quality leads and QP.

4. Write, approve and ensure the implementation of SOPs as well as manage the production planning and scheduling.

Role Requirements

To be successful in your application to this exciting opportunity as the Head of GMP Production we are looking to identify the following on your profile and past history:

1. Relevant degree in the Life Sciences field in addition to considerable experience of managing a GMP production facility including extensive Clean Room experience for Biopharmaceutical products, ideally Cell and Gene Therapies.

2. Proven industry experience in managing and supervising production staff. Ideally where you have built a team from scratch.

3. A working knowledge and practical experience with regulatory frameworks including Good Manufacturing Practises (GMP), MHRA, HTA and H&SE legislation for small scale clinical trial manufacturing.


Key Words: GMP | Good Manufacturing Practise | Production | Manufacturing | Facility | MHRA | HTA | Cell Therapy | Gene Therapy | Production Planning | Quality | Process Development | Line Management | Leadership | Development |