Cell Process Development Specialist
- Experience Level
- Experienced (non-manager)
Enara Bio™ (formerly known as Ervaxx) is a science-led company targeting the T-cell/cancer cell interface (the “immune synapse”) to develop new targeted cancer immunotherapies designed to treat a broad patient population. Our current focus is the development of novel T-cell therapies based on complementary and proprietary insights from interrogating the immune synapse from both angles – on the tumor side, a growing set of novel tumor-specific targets; and on the T-cell side, a set of robust T-cell receptors (TCRs) with potent tumoricidal activity.
Enara Bio 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 team. The company has offices in London, UK and laboratories in Oxford, UK.
Enara Bio is expanding its CMC expertise within the organisation, to deliver a pipeline of Cell and Gene Therapy products, including autologous ex vivo gene modified TCR-T therapeutics, to patients with cancer. We are now looking for a dynamic person with extensive scientific and cell process development experience to build the bridge between research and GMP manufacturing.
The role is multifaceted in working closely with the internal research teams on cross-functional projects, such as the development of next gen products, leading cell process development, and the assessment of novel methods and technologies. Further, the role will act as SME on projects with our external partners to establish robust cell processes.
- Provide scientific and technical expertise to and/or participate in research and development project teams
- Develop and execute on project plans to assess novel cell process technologies and methods internally and with external partners
- Partner with the research team to establish robust GMP compliant cell culture processes to rapidly advance next gen and new clinical candidates from the pipeline into manufacturing
- Transfer knowhow on cell manufacturing methods to and from external partners under development / GMP tech transfer
- Liaise and act as SME with external manufacturing, supply, and development partners
- Troubleshoot external manufacturing and supply activities
- Clearly communicate problems, risks and potential impact on timelines, as well as recommended solutions to senior management
- Author, review, and keep record of protocols, manufacturing and analytical documentation and reports
- Support in development of / write documents for regulatory submission packages for IND/ IMPD submissions
- Occasional travel to external partners will be required
Qualifications and experience required
- Degree in Life Sciences or related discipline
- Substantial and relevant post-graduate experience within academic or industry setting, preferably including an MSc or PhD
- Proven experience of working to objectives and timelines
- In-depth T-cell biology and process understanding
- Understanding of GMP regulations
- Extensive laboratory experience with cell culture and process development, ideally with primary human T cells at various scales
- Good experience with analytical methods to characterise T cells
- Excellent communicator, both written and verbal
- Self-motivated and enthusiastic team player with strong attention to detail
- Computer literate and ability to familiarise with different IT systems
- Experience with external contract R&D, cell manufacturing, and suppliers
- Hands on experience in global Regulatory filings / submission packages
- GMP process development and validation experience
- Experience with closed and automated process technology
- Experience working in project teams
- Project and/or people leadership experience
The Enara Bio team is driven to make a meaningful difference for people affected by cancer. Our culture is defined by our behavioural ethos:
- Act with unconditional positive regard and integrity
- Support each other to grow and develop
- Promote a collaborative, passionate and fun working environment
- Innovate by discussing issues, data and ideas openly
- Respect each other and value our diversity
- Embrace our shared goals and take ownership of our journey
We look for alignment with these values in all new team members.
Applicants should be able to demonstrate proof of the right to work in United Kingdom.
Enara Bio 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.