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GMP Training Manager - Biotech

GMP Training Manager - Biotech

Job Title: GMP Training Manager - Biotech
Contract Type: Permanent
Location: Stevenage
Industry:
Salary: Up to £50,000 D.o.E. plus excellent benefits
Start Date: ASAP
Reference: 16119 JH
Contact Name: James Hume
Contact Email: james.hume@nextphaserecruitment.com
Job Published: January 22, 2019 16:12

Job Description

James Hume is recruiting for a GMP Training Manager to join a leading biotech within the cell & gene therapy sector to develop and run their GMP training programmes to be based at their Stevenage site. The purpose of this new site is to manufacture therapies on a scale large enough for phase III clinical trials working in collaboration with academia and industry to bring these cutting-edge technologies to the market.  The Training Manager will be responsible for developing and running training programmes for both internal staff and for collaborators and lead the training strategy.

The Company

The company are a centre of excellence with the purpose to advance and accelerate the growth and development of the UK Cell & Gene Therapy sector.  They do this by collaborating with both academia and industry to take innovative therapies successfully across the translational gap to the clinic and then through clinical trials to launch.  They offer leading edge capabilities in process development, manufacturing in their state of the art laboratories as well as expertise in regulatory, clinical, market access and health economics.  To add to this, they opened a manufacturing facility based in Stevenage that comprises of 6 clean room suites which operates on a multi occupancy basis.  This is now doubling in size because of its success but also demand for their services.  Their long-term objective is to make the UK the place to come to commercialise therapies, by being the most compelling choice to their international partners.  They do not have a set therapeutic area but a large part of their focus is on immuno– oncology programmes.  They work in a very and dynamic forward thinking way looking to utilise the latest technologies enable them to remain at the forefront of research into this exciting sector that has great potential.

The Role

The role of GMP Training Manager has arisen out of the need to expand the services they provide collaborators and develop their own staff in GMP operations.  There is an increasing need to ensure all staff are GMP compliant as manufacturing operations increase as therapies progress through clinical trials and move beyond translational research.

You will be responsible for developing, maintaining and updating their overall training strategy of the Stevenage site for staff at all levels.  So that it meets current requirements with programmes developed specific to the different role types at the site.  There is a focus on the training of quality processes such as deviation reporting, investigation and root cause analysis too.  The company, as are the collaborators, expanding meaning you will design and participate in new starter training as well.

This role reports directly to the Head of QA meaning it is a high-profile role with a strong strategic element with involvement in other areas like quality operations.  With the purpose to not only translate these into training needs but also improve operations.  This site is doubling in size meaning you will be involved in related projects and have the chance to develop your career in the longer term.

Experience

You will need to have experience of working in a pharmaceutical / biotech aseptic manufacturing environment that is GMP regulated.  With demonstrable experience of developing and delivering GMP training programmes that includes gowning, cleaning, and disinfection activities.  You will need to have experience of writing, updating and improving written procedures.  Along with experience of working in a quality environment and related experience of processes like deviations, change controls or corrective actions.