Principal Scientist in Process Development

Location of role

Oxford, UK

CMC

The purpose of this job is to drive cell line development and experimental activities through scientific and technical leadership, enabling the advancement of the Company’s pipeline, process or technology capabilities. To facilitate process development and validation activities, including technical support and oversight for external cell line development, cell banking and establishment in GMP manufacturing, ensuring regulatory compliance.

• Primarily a lab-based role for oversight and creation of manufacturing cell lines, compliant with business and regulatory criteria to produce protein therapeutics for Research and Development, and GMP manufacture for clinical studies and commercialisation.
• Accountable for cell line development strategy and quality, in line with company objectives, enabling manufacturing at GMP and regulatory submissions
• Streamline cell line development, enabling Quality by Design, utilising process knowledge, DoE and scaled-down models where appropriate. Develop and evaluate new technologies and improvements to increase capabilities.
• Enable transfer, communication and technical support of cell line performance and manufacturing processes to contract manufacturing organisations
• Review technical documentation and advise advancement of manufacturing studies, to ensure success and regulatory compliance
• Guiding lines or areas of investigation by drawing on experimental and scientific expertise.
• Supporting and offering insights on technical and investigational aspects as well as the relevance to the wider objectives of the project, department and company
• Keep abreast of advances in the CMC regulatory and cell line development fields. Sharing knowledge acquired from conferences or elsewhere, to the wider team
• Problem solving and project prioritisation
• Contribute to CMC components of regulatory submissions
• Laboratory records & equipment:
  Ensuring that all records for the group, data and information are up to date, on time and recorded to the correct standard and that equipment is being used correctly and effectively.
• Health & Safety:
  Responsible for the day-to-day compliance with all H&S within the Group.
• Reporting: communicating and presenting research findings to senior management and relevant colleagues, as well as at partner and collaboration meetings; considering and understanding the wider impact of the data in communications. Using initiative to ensure advancing technologies and findings can be disseminated across the company.
• Managing the delivery of cell line development activities to agreed timescales and budget, identifying any issues/risks and escalating these as required.
• Interacting and communicating with research, CMC functions, CDMOs, QA and regulatory, as required.

May act as a mentor or manager to other colleagues.

• Excellent leadership, management and communication skills
• Mammalian cell line development for complex biopharmaceuticals
• Molecular biology; vector and gene design for optimal expression and product quality
• Mammalian cell cloning and assurance of monoclonality; cell line banking, stability and characterisation.
• Optimisation of mammalian cell line expression for manufacturing, including development of bioreactor processes
• Working knowledge of the relevant ICH Quality Guidelines relevant to development and characterisation of mammalian cell lines suitable for GMP manufacture of protein therapeutics
• Familiar with the principles of Quality Assurance (QA) and Good Manufacturing Practice (GMP)
• Line management of a small team
• Managed, mentored and/or coached individuals to greater success and advised on areas for improvement.
• Project managed simultaneous…