This is a truly rare opportunity where you will be joining this innovative start up with the responsibility for translating their ground breaking innovations into GMP manufacture. Taking these through the process development, scale up and tech transfer cycle. Their technology is based on synthetic and stem cell biology to reprogramme cells to develop iPSC’s to then derive these to any cell type in the human body. The purpose of this is to accelerate research & development of cell therapies, better understanding of diseases and advanced controls for bio manufacturing.
The Role of Process Development Manager:
As the Process Development Manager, you will be a leading the process development, optimisation, scale up and tech transfer to GMP manufacture for their iPSC cells. In this role you will be using your science and expertise to deliver robust manufacturing processes to enable to translation of product from proof of principle to manufacture. You will be working cross departmentally with groups including R&D, Quality, Clinical, Logistics and Business Development.
The responsibilities include:
- Lead a team of scientists to establish and effective process development capabilities to complement their advanced R&D function.
- Operational and strategic leadership of the team.
- Key contributor to the development of the company through strategic programmes that drive forward innovation for the manufacture of human iPSC cells.
- Work in collaboration with other Group Leaders.
- Provide scientific leadership for the scale up and tech transfer of processes to pilot scale, in house and out sourced manufacturing.
- Coach and mentor team members to support their development and growth of the team.
- Continue to keep pace with developments in the sector and horizon scan to implement any relevant technologies to optimise processes.
- Experience of Process Development in a relevant field – iPSC, stem cell, cell therapy, biologics etc.
- Proven experience of developing, optimising and transferring processes from small scale to GMP manufacture.
- Understanding of GMP and QbD processes in a manufacturing environment.
- Expertise in the characterisation, culture, and QC of mammalian cell systems.
- Experience of leading or supervising people.
- Experience of working with iPSC cells or Stem Cells is an advantage
- Experience of cell culture automation and cell manufacture.
They are based in Cambridge and their step change technology that is a combination of stem cell biology and synthetic biology. The purpose of this is to accelerate the discovery, development, and manufacture of cell therapies through the control of synthetic biology circuits.
Their aim is to build a scalable model that enables the production of cells that are actually affected by the targeted disease and accelerate the development of cures. Their focus is currently on human induced Neurological and Skeletal stem cells.
They received significant funding to complement their own plans which has led to a rapid expansion as they meet their current aims and work towards the development of new ideas.