James Hume is seeking a Production Manager to join a clinical stage cell therapy company in a strategic role who are continuing to expand as their therapies progress through clinical trials towards commercialisation. They need to recruit a manager who will be responsible for the overall production strategy for the site covering the transfer, qualification, and validation of methods for manufacture for use in their clinical trials. This is an exciting prospect as the role enables the holder to take on an influential role where you can grow as the company develops, their pipeline expands and products are commercialised.
A pioneering and ambitious Biopharmaceutical company who develop next-generation, programmed T-cell therapies to treat haematological cancers and solid tumours. The organisation has existed for 4 years and is very well funded, with a clear strategy and expansion plan for the next 3 years and beyond. Scientifically, the company has extremely exciting technologies, using a broad suite of proprietary and modular T-cell programming to engineer precisely targeted, controlled and highly active T cells. Commercially, they have a pipeline of product candidates in development (for the treatment of haematological malignancies and solid tumours) and is increasing its GMP production capacity. Based in a state-of-the-art facility in Stevenage, Hertfordshire, you will join a team that is doing something genuinely meaningful.
The role of Production Manager is an influential position within the Technical Operations Team, that is responsible for the transfer, qualification, and implementation of manufacturing processes for use within clinical trials. You will be responsible for the contributing to and then implementing the site strategy for manufacture of products. You will be overseeing the transfer, qualification, and validation of methods for manufacture as well as other responsibilities such as CTA documents. Alongside the production you will also be responsible for maintaining compliance to GMP in the laboratories, associated documentation and the hosting of audits.
As the Production Manager, you will be leading a team of scientists and you will be responsible for their development as the team grows to meet the changing business needs. Due to the seniority of this role you will be working closely with Associate Directors and Directors within the Technical Operations team as well as within Clinical and Process Development. Contributing to wider company strategies, direction and working in collaboration to achieve joint projects.
Desired Skills and Competencies:
For this role, you will need to have demonstrable experience within the life science / pharmaceutical / biotech sectors with experience of production in GMP or similar regulated environments. With experience of working with biopharmaceutical / cell therapy or related products using cell based technologies. You will need to be educated to a higher level (MSc or PhD for example) with relevant experience within a commercial setting. With experience of successfully leading teams.
Salary and Benefits:
- Salary – Competitive
- 25 Days Holiday
- Pension – 5% matched contributions
- Life Assurance – 4 times base salary
- Group Income Protection
- Private Medical Insurance
- Dental Cover
- Eyecare Vouchers.