James Hume is seeking a GMP Training to join a clinical stage cell therapy company in a strategic role, they are continuing to expand as their therapies progress through clinical trials towards commercialisation. They are setting up a GMP academy where they will provide training to staff on GMP across all their areas from clinical to production. This is to keep pace with demand the changing needs of their business as they move towards the commercialisation of their current products and develop their pipeline further. The first step is to recruit someone to design and deliver GMP training company wide to then build a team going forward.
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 GMP Training Manager is unique due to its strategic positioning and the role it will play as they company continues to expand. You will have the responsibility to design and then deliver training on GMP and how to comply from the basics such as SOP’s, through to more complex scenarios such as the technical knowledge transfer of new processes from production to manufacturing. To all levels of staff within the production, process development, quality control, and quality assurance departments. So that staff are fully aware of their responsibilities and how to adhere to GMP.
You will be responsible for planning annual training for the maintenance of knowledge through regular training programmes as well as focusing on new starters to the company. In addition to the training you will also support the authoring of regulatory documentation, disseminating regulatory updates to all staff and strategic support to the quality and regulatory teams. Due to the seniority of the role you will be working closely with senior members of the Quality and Regulatory team to help develop strategies for the company’s continued compliance.
Desired Skills and Competencies:
For this role, you will need to have experience of working in a similar GMP biopharmaceutical / biotech environment with knowledge of manufacturing preferably using automated processes. You will need to have designed and delivered GMP training programmes to staff and then managed training programmes. You will need to have a higher-level degree (MSc or PhD for example) or equivalent experience gained within industry. With knowledge of both quality and regulatory guidance related to the manufacture of biopharmaceutical products.
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