Ervaxx is pioneering the use of Dark Antigens™ to deliver TCR-based T cell therapies and targeted off-the-shelf cancer vaccines for treating and preventing cancer. Ervaxx Dark Antigens derive from vast untapped expanses of genetic ‘dark matter’ beyond the normal coding regions of the genome. Ervaxx has identified Dark Antigens that map to multiple solid tumor types and generate robust, antigen-specific T cell responses.
Ervaxx was founded in 2016 and has been well funded to invest in the build out and growth of our proprietary discovery platform and our fantastic Ervaxx team. The company has offices in London, UK and laboratories in Oxford, UK.
Ervaxx Ltd is advancing activities in order to deliver a number of T cell-based therapeutics, including TCR-T and ex vivo manipulated autologous products. We are now looking to enhance the Research-to-Development (R2D) expertise within the organisation and establish a leadership role that will partner with the research team and ensure Cell therapy processes and technology are optimised and translatable into the GMP manufacturing and clinical applications.
The role of the Associate Director/Director of Cellular Therapy Process Development will be to establish and be responsible for the cell therapy R2D activities within the company, acting as key technical expert establishing key criteria, technology and process that will allow ultimate successful integration of strong scientific research into a product with clinical utility.
Establish and have responsibilities for process development and optimisation for Cell therapy within the company:
- A technical expert in defining strategy, priorities and activities for T cell therapy, including:
- Technologies and methodologies for the T cell manipulation for TCR-T (including MR1 TCRs) autologous products
- Technologies and methodologies for the ex vivo manipulation of T cells for reinfusion in an ex vivo autologous stimulation product
- Partner with research team to ensure R to D transition is optimised to facilitate robust and scalable manufacturing (GMP/CMC) process
- Initiate and support collaborative activities with academic clinical groups and external parties to establish early phase clinical trial process and activities
- Manage external CROs and CDMOs ensuring clear communication of company goals and timely delivery of projects to meet internal deadlines
- Clearly articulate and communicate findings and recommendations to senior management and the board of directors, as required
Develop plans for next generation cell therapies and support advanced cell therapy product development:
- Establish strategy for Development of next generation TCR-T with focus on allogenic approaches
- Act as internal expert on the latest technology and advancements in the field, driving strategies to answer key questions in oncology, such as immunosuppressive TME, persistence, exhaustion, tumor homing, monoclonality, next generation vector delivery, etc
Minimum Qualifications and Experience required
- PhD in relevant scientific discipline (preferably immunology) preferred
- Minimum of 10 years’ experience in positions of scientific expertise including experience in process optimisation for cellular therapies, preferably within the biopharmaceutical setting
- Comprehensive knowledge of and cutting-edge technical expertise in cellular therapies
- Hands-on experience with viral vector and ex vivo gene delivery methods for engineering of primary T cells
- Extensive know-how of the technical requirements and proven ability to translate and progress research methods into the development and GMP setting, informing and guiding early research to this goal
- Experience with managing external partners, collaborators and CROs; knowledge and tech transfer experience from internal to Manufacturing organisations
- Prior experience of managing projects (external and internal) with ability to coordinate and track integrated functions
- Prior experience of direct or indirect management, preferably with experience of cross-functional matrix team oversight
- Strong attention to detail, communication skills and a team player who is willing to question the status quo and speak out in a tactful and persuasive way
- Maintain a high level of knowledge in the T cell therapy field, keeping abreast of the latest developments as well as proactively identifying novel next generation approaches
- Contribute to the preparation of CMC sections for regulatory submissions (e.g. IND/IMPDs, etc.), patents, progress reports, and publications
- Pharmaceutical products GMP manufacturing experience
- Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred
Applicants should be able to demonstrate proof of the right to work in United Kingdom.
Ervaxx Limited is an equal opportunities employer.
We offer a competitive salary, commensurate with qualifications and experience, and a benefits package including pension and health insurance.
N.B. No free parking facilities are currently available on either the Oxford or London sites