Tech Transfer Specialist GMP Biologics

Job Description

Are you experienced in GMP Manufacturing of biologics or cell therapies in an aseptic environment If so, 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 Tech Transfer Specialist to take responsibility for the transfer of scalable manufacturing processes, projects and knowledge into their new cutting-edge manufacturing site based in Braintree. The role would initially be based remotely although required to live commutable distance from Braintree and ultimately being based in Braintree.The company founded in 2012 with the drive to grow and support the sector in the UK. Has 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 £100 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 Tech Transfer Specialist is to manage the transfer of scalable manufacturing processes into this cutting-edge facility. Overseeing the transfer of process, projects, and knowledge to the site.Responsibilities include:- Involvement in the end-to-end transfer of internal and external tech transfer activities - outsourced process development and / or GMP manufacturing processes- Collaborative work with the Innovation Team and Process Development groups to manage the transfer of scalable manufacturing processes.- Deliver project goals on time from external CMO’s working in technical collaboration and direct input into activities.- Tech Transfer of processes both into and out of the manufacturing 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:- Demonstrable experience of GMP manufacture of ATMP’s, Biologics or related sectors- Understanding of Upstream and / or Downstream processing- Experience of cell culture of human ad / or mammalian cell line- 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.