ProClinical’s client, a leading biotech within the immuno-oncology field, is currently seeking to hire a Stem Cell Bioprocess Development Group Lead. The incumbent of this role will 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.
- Leadership of the of the Stem Cell PD team
- In collaboration with senior scientists, provide technical review of experimental designs, results, conclusions and the process development plans of the Stem Cell PD team
- 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
- Lead the tech transfer of new and updated stem cell processes to our CMOs
- Manage any outsourced development activities for Stem Cell PD with subcontractors, collaborating cross functionally as appropriate
Skills and Requirements:
- BSc or higher in relevant area.
- Experience with bioprocess development of stem cell derived products, with relevant industrial experience.
- The role requires a depth of experience in the process development, optimization, scale-up and technology transfer of bioprocesses.
- 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.
- 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Chidozie Orji on +44 207 4400 671 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.