We are looking for a driven and enthusiastic lab-based Principal/Senior Scientist to work in our Stem Cell Process Development Team. As part of the Universal T cell project, aimed at developing novel off-the-shelf allogeneic stem cell-derived affinity-enhanced T cell therapeutics, the primary focus of this role is to conduct scientific experiments to support development of stem cell-derived T cell manufacturing processes. The role is a collaborative one, working closely with the functions in Research, Quality and Regulatory as part of a cross-functional project team to deliver a Universal T cell product to the clinic.
Reporting to Group Leader, the applicant will be able to work both independently and as part of a team to design, perform, analyse, and report on high quality experiments. The individual will be responsible for scientific projects within the Stem Cell PD team including internal process development activities, tech transfer and cell banking.
Depending on the requirement, individuals in this role may be involved in project work-stream leadership/management and/or supervision of other junior scientists or technicians.
Please note, we are looking to start the successful candidate no earlier than April.
- Design, conduct and report on scientific projects both individually and as part of a team – 50%
- Collaborate with research to provide technical review of experimental designs, results and conclusions – 25%
- For relevant projects, lead the tech transfer of new and updated stem cell processes to manufacturing teams – 20%
- Project leadership – 5%, This percentage may rise or fall depending on requirements and level of experience
Qualifications & Experience
- BSc or higher qualification in relevant area. Experience with bioprocess development of stem cell derived products and relevant industrial experience.
- The role requires a depth of experience in the process development, optimization, scale-up and technology transfer of bioprocesses. The role will be expected to lead and support scientific projects within the stem cell process development team and may be responsible for the development of the GMP drug substance / product process, transfer of these processes and GMP cell banking. Therefore a deep understanding of technologies suitable for several of these responsibilities is required. Hands-on experience with pluripotent stem cell culture (iPS and ES lines) and differentiation protocols for multiple lineages are both essential. Being able to apply bioprocessing know-how to the optimisation and scale-up of stem cell expansion and differentiation protocols will form a significant part of this role.
- Experience with the quality control of stem cell differentiation via molecular and staining methodologies
- The role will also be responsible for the tech transfer of new or updated processes to our CMOs. Therefore the role requires an in-depth understanding of tech transfer and GMP translation to include the technical review of documentation such as process descriptions, sampling plans and batch records. Additionally experience with the risk assessment of raw and starting materials to determine their suitability for GMP manufacture will be required.
- Prior experience of GMP cell banking and characterisation, according to ICH guidelines, for stem cell lines is also essential.
- Knowledge and experience of the application of QbD principles, and in particular risk-based process development, would be a significant advantage.
- Prior experience of using engineering principles in bioprocess design and scale-up would be advantageous.
- Experience of assisting in the authoring of regulatory submissions (IND/IMPD) would also be a significant advantage.
Skills & Competencies
- The relevant skills and competencies to provide scientific leadership of projects within the team. These skills include the ability to supervise other scientists with the laboratory, provide practical training and knowledge transfer to others.
- A key requirement is the ability to work collaboratively both within the team and externally. The role requires cross-functional working to ensure success; working with Stem Cell Research scientists, Quality and Regulatory colleagues to deliver a Universal T cell to the clinic. A collaborative approach will be required for success as the PD and Research teams will work extremely closely in order to develop this manufacturing process.
- The role requires an excellent communicator who is able to provide clear messages, both internally and to external partners.
- Skills and knowledge relating to the development, scale-up and tech transfer of bioprocesses destined for GMP manufacture are key for this role. Their skills should include the ability to critically examine in-process data, evaluating both yield and product quality leading to a risk based approach to further optimise and understand the bioprocess. An attention to detail is also key to enable thorough review of development reports, tech transfer documents and batch records.
- Knowledge of statistical experimental design (such as DoE) would be a significant advantage.
- Experience with project laboratory techniques and equipment including flow cytometry, cell counting, cell washing and concentration and bioreactors
Decision Making Authority
The responsibility of the role is to drive the completion of scientific projects. The job holder will be expected to make decisions and recommendations based upon data from experiments to drive the process development strategy.
Input into the Stem Cell PD group budget.
Travel to CMOs and/or development partners may be required during tech transfer, this will likely be to both the US and EU.