Senior Tech Transfer Specialist GMP

Job Description

This is an excellent and influential opportunity to secure a position for a company that is a driving force behind the Cell & Gene Therapy Sector. The opportunity is to join as a Senior Tech Transfer Specialist to take lead on the transfer of projects, processes and knowledge between this site and external parties. This role is based at their world leading and new cutting-edge manufacturing site based in Braintree. The company founded in 2012 with the drive to grow and support the sector in the UK. They now expanded to 3 sites, with this role being based at their new Braintree facility into which they are investing £55 million initially and will be followed by a further £110 million over the next five years. With the aim to address challenges faced in the sector but also make this a best-in-class facility – which it already is. Added to this is that this site will be manufacturing therapies at a commercial scale and a COVID vaccine as part of the Government’s response. Purpose of the Role:The purpose of the role of Senior Tech Transfer Specialist is to take the lead in the transfer of processes, projects and knowledge into the site and external parties. Focusing on the transfer of scalable manufacturing and GMP manufacturing profiles. As a Senior member of the team you will be contributing to the setup of projects and contracts underpinning contract manufacture.Responsibilities include:- Leading both internal and external outsourced manufacturing and / or GMP process development tech transfer projects- Deliver projects through technical and operational input into the projects- Closely collaborate with CMO’s through direct input into both technical and project activities to deliver milestones on time- Transfer of projects into and out of the facility- Contribute to the contractual agreements, specifically the SLA’s, technical and quality agreements- Lead interaction with Process Development & Innovation Groups to transfer scalable manufacturing process into the facility.- Maintain of the site wide QMS- Input into the development of projects and the design & implementation of principals at the site.Desired Skills and Experience:For this opportunity you will need to have:- Proven experience of GMP manufacture of ATMP’s, Biologics or related sectors- Technical expertise of Upstream and / or Downstream processing- Experience of cell culture of human ad / or mammalian cell line- Experience of QMS- Experience of supervision, mentoring or leading others- Experience in the writing of Batch Records or manufacturing protocols- BSc or higher qualification in a relevant life scienceCompany Summary:The company were established in 2012 with the purpose to make the UK the place to commercialise Cell & Gene Therapies working in collaboration with partner based in the UK, Europe, US and Asia for example. They offer cutting edge technology, services, and capabilities to take a therapy across the translational gap; into the clinic, through clinical trials to launch. Offering the capabilities to fully commercialise these life changing therapies. With the drive to continually evolve to meet the continuing needs of the sector and address the key challenges faced successfully.