Stem Cell Bioprocess Dvevelopment Group Leader PD1

Provide leadership for the development of stem cell derived GMP manufacturing processes within the Process Development department and as part of the Universal T cell project team. The role is a collaborative one, working closely with the functions in Research, Quality and Regulatory.
Key Responsibilities
Leadership of the of the Stem Cell PD team - 20%
In collaboration with senior scientists , provide technical review of experimental designs, results, conclusions and the process development plans of the Stem Cell PD team- 25%
In conjunction with the Head of Project and PM support coordinate CMC activities and timelines including process development, cell banking and Quality sections for IND - 20%
Lead the tech transfer of new and updated stem cell processes to our client's CMOs - 15%
Manage any outsourced development activities for Stem Cell PD with subcontractors, collaborating cross functionally as appropriate - 20%
Qualifications & Experience
Required - BSc or higher in relevant area. Experience with bioprocess development of stem cell derived products, with 10 years relevant industrial experience. The role requires a depth of experience in the process development, optimization, scale-up and technology transfer of bioprocesses. The role would lead the stem cell process development effort and would be responsible for the development of the GMP drug substance / product process in addition to cell banking. Therefore a deep understanding of technologies suitable for scale-up of bioprocesses including bioreactors (suspension or adherent based cell culture). Experience with pluripotent stem cell culture (iPS and ES lines) and differentiation protocols for multiple lineages. Being able to apply bioprocessing know-how to the optimisation and scale-up of stem cell expansion and differentiation protocols. 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. Experience of in-plant presence during tech transfer. Experience with the risk assessment of raw and starting materials to determine their suitability for GMP manufacture. Prior experience of GMP cell banking and characterisation, according to ICH guidelines, for stem cell lines is also essential.

Desirable -Knowledge and experience of the application of QbD principles and risk-based process development. Experience of using engineering principles in bioprocess design and scale-up. Experience of assisting in the authority of regulatory submissions (IND/IMPD). The relevant skills and competencies to provide line management of a process development team (4-8 scientists) are necessary. These skills include the ability to, motivate, delegate, and provide personal development insight for direct and indirect reports. Furthermore the ability to simultaneously improve both efficiency and quality within the team are required through driving efficient team work is required. A key requirement is the ability to work collaboratively both within the team and externally. Cross-functional working to ensure success with Stem Cell Research scientists, Quality and Regulatory colleagues to deliver a Universal T cell to the clinic. The role requires an excellent communicator.
Travel the US and EU.