bit.bio is an award-winning spinout from the University of Cambridge. Our breakthrough technology combines synthetic and stem cell biology for the precise, efficient and consistent reprogramming of human cells used in research, drug discovery, and cell therapy. At bit.bio, we are passionate about engineering human cells that will enable the medicine of the future. To do this we need talented and curious people who want to make an impact on the future of science and therapeutics.
As a team of individuals, we value science, collaboration, openness, curiosity and creativity. We are united by trust and respect for each other.
Location: Babraham Research Park, Cambridge
Type: Full time, permanent
Salary: Competitive / Hours: 40 p/w
Lab based position
Your role in our team:
Reporting to the Associate Director, QC & GMP Analytical Development, the Scientist, Quality Control will be responsible for successfully implementing QC testing for cell banks, starting materials, drug substance, and drug product to support clinical manufacture of our first clinical cell therapy candidate.
This is an exciting opportunity to contribute to the development of next-generation cell therapies, with cross-functional collaboration with stakeholders across quality, regulatory, and CMC. This will involve active participation in all elements required for successful delivery of a cell therapy testing package, including identification of characterisation and QC tests, CTO and CDMO selection, new technology evaluation, and partnership with analytical development and external partners for assay transfer and qualification.
Additional key responsibilities include selection of external labs for testing for starting materials and oversight of execution of these tests.
Your key responsibilities will include:
- Lead method transfer, establishment, and qualification of multiple assays for QC release for a novel engineered cell therapy, including flow cytometry, ddPCR and/or qPCR, and cell-based functional assays
- Participate in selection of CTOs and CDMOs for a variety of compendial and product-specific analytical methods required for testing of starting materials, drug substance, and drug product
- Collaborate with analytical development team members to ensure method readiness for transfer to GMP testing labs, including review of method development reports and SOPs
- Collaborate with cross-functional external and internal partners for relationship and lifecycle management to support
- Interface with quality assurance and regulatory teams to appropriately incorporate current regulations and guidance into the testing approach
- Have a BSc/MSc in Molecular Biology, Cell Biology, Biological Sciences or similar; or equivalent experience
- Are a seasoned CMC professional, with significant industry experience, including several years of experience in quality control for advanced therapies preferably within cell and gene therapy
- Have demonstrable success of working effectively in complex matrix project team environment including external partners and customers
- Are results oriented; able to demonstrate creative problem-solving skills under resource constraints and time pressure; able to apply innovative thinking to problem solving for novel challenges
- Excellent multitasking and organisational skills
- Are an outstanding communicator across all levels within an organisation; have strong influencing and negotiation skills
- Are humble - sincere and secure - accepts own mistakes - prioritises team over personal goals
- Are hungry - driven and proactive - goes above and beyond call of duty to achieve company results
- Are smart - astute and persuasive - uses emotional intelligence to lead and inspire colleagues
With essential experience in…
- Proven experience in quality control for advanced therapies
- Knowledge and in-depth understanding of ICH guidelines for analytical validation, and corresponding experience with phase-appropriate method qualification or validation
- Experience in managing CTOs and CDMOs, including experience with technology transfer and management of third party validation
- Familiarity with testing including including safety testing as per USP/JP/EP and applicability of each compendia
- Strong technical writing skills, including writing method SOPs and validation protocols and reports
- Experience with GxP-based laboratory setting, regulatory guidance and MHRA requirements
- PhD Cell Biology, Stem Cell Biology or similar; or equivalent research experience
- Experience with qPCR or ddPCR
- Experience managing technology transfer in a pre-clinical or clinical stage biotechnology start-up
More reasons to join us:
bit.bio provides a vibrant and dynamic work environment in an exciting, fast-moving time for biology. We work with cutting edge technologies and with our world-leading scientific advisory board. We conduct pioneering work with real-world impact.
We trust our people to make significant contributions early on with opportunities to be involved in projects that are key to the success and growth of our young company. We invest in people, creating opportunities for personal development in an inclusive multi-skilled team with ambitious goals that provide opportunities to learn on the job from each other.
Creativity and open minds are encouraged for everyone to contribute to the success of the company.
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