IntroductionEnara 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.
Job SummaryAs a key member of the Enara Bio Management Team, the Vice President/Senior Vice President Cell Therapy Manufacturing has global responsibility for leading the overall strategy and operations relating to process and analytical development, manufacturing and supply of Enara Bio cell therapy products. The VP/SVP Cell Therapy Manufacturing will be responsible for building all aspects of the internal and external manufacturing capabilities and infrastructure ensuring Enara Bio can rapidly advance the next generation of adoptive cellular immunotherapies.
- Act as a member of the Enara Bio Management Team assuming full responsibility for all Enara Bio manufacturing commitments, making key contributions to the achievement of the Company’s business plan
- In collaboration with the Board and Enara Bio Management Team, develop and execute the holistic cell therapy manufacturing strategy for both first- and next-generation products in line with the Company’s strategic goals
- Lead, build and manage the process and analytical capabilities, manufacturing capabilities, cGMP architecture and supply chain to support clinical trials for the Company’s cellular immunotherapy products
- Represent the Company in interactions with global cGMP regulatory authorities and hold responsibility for overall regulatory compliance
- Oversee the management of global contract manufacturing partners and external academic/commercial groups, fostering strong and mutually beneficial partnerships
- Formulate, monitor, and control budgets, human resource, and capital expenditure
- Seek external advice through, industry forums, consultants and global collaborators to meet manufacturing development goals and ensure the Company is at the forefront of cell therapy manufacturing
Minimum Qualifications and Experience required
- Appropriate qualifications in the life sciences that will include a second or advanced degree
- At least 10 years of industry or relevant academic experience in advanced biologics-based manufacturing (cell therapy, gene therapy, complex biologics, vaccines, or other relevant products), including at least 5 years developing oncology-focused cell therapy products
- Possess a proven “hands-on” track-record and expert knowledge in process development, scale-up and commercial stage manufacturing of complex biologics
- A practical understanding of viral vector gene delivery methods for cell therapy
- Familiarity with the challenges and opportunity in developing new immuno-oncology products
- Working understanding of the quality aspects of developing cell therapy products, including quality by design (QBD) principles and the latest QA/QC guidelines
- Practical demonstration of hands on process development including use of statistical design of experiments (DOE) is required. Experience with automation technologies is desired
- Ability to be innovative within constraints of cGMP environment with a drive to reduce manufacturing timelines and where possible cost-of-goods
- A strong global project manager, with a demonstrated ability to execute and deliver value-creating solutions to the most complex of global manufacturing issues
- Experience of establishing and overseeing manufacturing to support clinical trial and commercial operations with an expert knowledge of biotechnology plant operations
- Regulatory experience (e.g. ICH/FDA/EMA/GMP) including audits, organizing and writing regulatory submissions, and personal interactions with FDA/European National Competent Authorities
- Demonstrated ability to work closely with, and influence regulators, in an environment where path-to-market is not well defined
- Strong and proven leadership capabilities and proven managerial skills are essential: self-motivation, enthusiasm and ability to interact within a multi-disciplinary environment with multiple stakeholders
- Experience in a fast-paced, entrepreneurial, high-growth environments
- A passionate, patient-centric, inclusive, empathetic, open-minded, collaborative and forward-thinking approach.
- Embracing of a growth mindset of continual self-improvement and perpetual curiosity
- Seeks regular feedback from peers and direct reports, as well as offers constructive feedback to all teammates
- Demonstrable ability to work influentially and collaboratively as both a functional leader and Senior Team member
- Bright, creative and hard-working with a commitment to make a significant contribution to the Company and new therapies.
- Excellent oral and written communication skills, capable of influencing a broad spectrum of stakeholders
- Problem-solving with a flexible and pragmatic approach, a business mind-set, the ability to manage change and be comfortable with ambiguity
Closing dateUntil filled
Further informationApplicants 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.
N.B. No free parking facilities are currently available on either the Oxford or London sites.