Downstream Process Development, Principal Scientist
91 Park Drive, Milton Park, Oxfordshire, OX14 4RY, UK
To drive process development and experimental activities through scientific and technical leadership, enabling the advancement of the Company’s pipeline, process, or technology capabilities. To contribute to process development and validation activities, ensuring regulatory compliance.
- Conduct and design experiments to support manufacturing at GMP and regulatory submissions
- Oversee the downstream process production of biologics to support process validation, analytical characterisation and formulation studies
- Streamline downstream process development, enabling Quality by Design, utilising process knowledge, DoE and scaled-down models where appropriate, enabling processes fit for post-Phase 1 clinical studies and commercial
- Input to the design and execution of Process Validation plans, protocols and processes, working closely and with oversight of CMO
- Enable transfer, communication and technical support of 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.
- Contribute to CMC components of regulatory submissions
- Keep abreast of advances in the CMC regulatory and downstream processing field
- 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 projects to the agreed timescales and standards, identifying issues that need to be addressed and escalating these as needed.
Experience and Knowledge:
- Managed, mentored and/or coached individuals to greater success and advised on areas for improvement.
- Project managed simultaneous projects within bioprocess development, understanding the impact across the wider project team
- Familiar with the principles of Good Manufacturing Practice (GMP)
- Line management of a small team
- Communication and transfer of technical information to external organisations & provide troubleshooting/support
- Owned and delivered significant changes that have measurably improved company pipeline, process or technology capabilities and leading teams through adoption, implementation and change.
- Researched and resolved complex situations and issues through further external research using own initiative.
- Worked/works as an experimental scientist or leader within a laboratory environment with a recognized and established expertise in downstream process development
- Demonstrated an advanced level of downstream process development skills, applied to the principles of GMP
- Designed successful processes to scale-up for drug manufacturing for clinical use. Carried out technology transfer of biologic production processes to Contract Manufacturing Organizations (preparation of study reports and technology transfer documents, as well as troubleshooting process transfer issues) and review of manufacturing documentation.
- Process Validation with technical experience ensuring the validation is fit to support a commercial application
- Proven ability to analyse and interpret complex datasets and propose sound experimental strategies
- Maintained awareness of new developments in their respective field; implementing change
Education and Qualifications:
- Essential: BSc. Or MSc. in protein engineering, microbiology, biochemistry, molecular biology or related discipline
- Desirable: PhD in related discipline