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Training Manager - GMP

Training Manager - GMP

Job Title: Training Manager - GMP
Contract Type: Permanent
Location: Stevenage
Industry:
Salary: Competitive D.o.E. plus bonus & excellent benefits
Start Date: ASAP
Reference: 16229 JH
Contact Name: James Hume
Contact Email: james.hume@nextphaserecruitment.com
Job Published: April 30, 2019 10:51

Job Description

A Biotech with great potential who are developing fast due to their continued success are seeking GMP Training Manager to play a key role in ensuring staff are well trained and contribute to their growth.  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 Company:

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 Opportunity:

This role will be based within the quality team with the purpose to contribute to and deliver training programmes for all Quality and Production team members.  This is a core part of their development as they are growing rapidly as therapies progress through trials to reach the market.  You will be working with the Head of Department who has been developing the training strategy with the purpose to contribute to this as they continue to grow to keep it effective and compliant to GMP.

You will be training Production Scientists who are undertaking cell based GMP operations, QC Scientists who are completing GMP testing activities for stability and batch release for use in clinical trials and QA Scientists to give them an insight into the production process.  In addition, you will develop bespoke programmes for certain situations when these arise, working with the relevant managers to deliver these.  You will also assist in other areas such as the provision of regulatory updates and reports, work with external providers where necessary and maintaining the database.

This is designed to be a dynamic role where you will be able to apply your training expertise as part of a fast-developing team.  Adding your own ideas to continue to improve systems, spot gaps and bring your own ideas with you as they continue to develop meaning this role will evolve over time and has excellent growth potential.

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 working in aseptic or clean room environments.  You will need to have developed or delivered training programmes either as the sole focus of or as part of your role.  With a good understanding on GMP operations in a relevant laboratory environment.