Principal Scientist in Process Development in Oxford

Location of role

Oxford, UK

Department

CMC

Key Responsibilities

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.

Key responsibilities

• 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.

Other

May act as a mentor or manager to other colleagues.

Experience and knowledge Essential

• 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 projects within bioprocess development, understanding the impact across the wider project 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 mammalian cell line development
• Demonstrated an advanced level of cell line development skills, applied to the principles of GMP
• Designed successful biologics processes to enable 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.
• Proven ability to analyse and interpret complex datasets and propose sound experimental strategies
• Maintained awareness of new developments in their respective field; implementing change
• Contributed to and influenced the strategic scientific direction of a large group

Desirable

• Microbial expression and optimisation for recombinant proteins
• Management of a group budget
• Familiar with process scale up activities aimed at achieving complete process understanding and control, as well as building robustness into biologics production platforms using DoE. Use of scaled-down models to support this.
• Regulatory document writing contributions and reviewing (eg. IND, IMPD)
• Current knowledge pertains to drug development of biotherapeutics
• Assessment of protein expression and quality, such as with Octet BLI or HPLC techniques
• Awareness of requirements for Process Validation and requirements for BLA/MAA submissions for a biopharmaceutical
• Participated in external scientific collaborations to drive and further technical understanding

Education And Qualifications

• Essential: BSc. Or MSc. in protein or biochemical engineering, biochemistry, microbiology, molecular biology, or related discipline
• Essential: Relevant industrial or post-doctoral academic experience
• Desirable: PhD in related discipline

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients' lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.