GMP Training Lead
|Job Title:||GMP Training Lead|
|Salary:||£0 - £51000 per annum, Benefits: bonus, pension, life insurance, health insurance and other flexible benefits|
|Contact Name:||James Hume|
|Job Published:||January 23, 2020 12:03|
A cutting-edge biotech is recruiting for a GMP Training Lead for their Stevenage site, to take ownership of their training programs by developing, implementing and then running their strategy for this cutting edge multi occupancy manufacturing facility. The company are a leading the way in the commercialisation of life changing therapies, taking these through the commercialisation process using their expertise and cutting-edge services.
As the Training Lead your ultimate responsibility is to ensure that every staff member at the site and hosted collaborators are trained in line with GMP requirements. You will be working with the Head of QA and take ownership of the training function by developing, implementing and then running the training strategy for the site. The training covers aseptic manufacturing operations, QMS tools and techniques such as root cause analysis. Using your expertise to develop plans to meet these needs in compliance with GMP and industry requirements, working the relevant HR and QA colleagues as needed.
As the Lead you will be responsible for the day to day management and development of the training team. Managing the resources effectively to ensure all training can be delivered effectively. This is a highly visible role where you will be leading collaborations with third parties that is a mixture of collaborators, and academic institutions to develop programmes that are in line with industry needs. Working to ensure programmes keep pace with needs and are continually improving.
Desired Skills and Experience: You will need to have demonstrable experience of establishing and running training programmes in line with GMP in relevant aseptic manufacturing environments. Ideally complemented by experience of quality processes such as deviations, change controls and / or corrective actions. With a good understanding of EU / MHRA regulations, and preferably experience of FDA requirements, however this is not essential for this opportunity.
The Company: The company are a centre of excellence that is at the forefront of creating a viable and sustainable cell and gene therapy industry. Their headquarters are in central London where they have built a leading multidisciplinary team that has the ability to take a therapy from concept through the development cycle to the market. They collaborate with both academia and industry and they are able to provide the scientific, clinical and commercial expertise needed to overcome the challenges that hinder the commercialization of these fast developing, cutting edge technologies. They have constructed a purpose-built manufacturing centre which opened at the end of 2017 and immediately after opening additional funding was allocated for the centre to be doubled in size due to the demand for their services. This currently consists of 12 (of which 6 very recently completed) clean room suites out for collaborators to use to manufacture advanced therapies for use in clinical trials.
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