Scientist, GMP Analytical Development
at Bit Bio
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, GMP Analytical Development will be responsible for successfully developing and refining assays for subsequent transfer to a QC laboratory 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, translational medicine, and CMC. This unique opportunity involves active participation in all stages of the analytical development and method transfer process, including evaluation and selection of testing equipment, assay fit for QC testing, method development, and transfer and establishment at external GMP laboratories.
The successful candidate will execute key analytical development and method transfer activities for our first cell therapy product. This is a lab-based role.
Your key responsibilities will include:
Develop methods for QC release testing of bit.bio’s first clinical cell therapy candidate, including flow cytometry, qPCR/ddPCR, and/or cell-based assays
Evaluate equipment and method fit for application in GMP testing labs in partnership with quality control and assist in testing lab selection as needed
Author SOPs and method development reports in preparation for method transfer
Ensure successful method transfer to CDMO and/or CTOs in collaboration with QC and external partners, serving as technical SME
This is a hands-on position, requiring execution of laboratory studies
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 demonstrable experience in analytical development or quality control
Have demonstrable success of working effectively in complex matrix project team environment
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, analytical and organisational skills
Are an outstanding communicator across all levels within an organisation
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 industry experience in the field of advanced therapeutics
Experience in method development and qualification, including writing method SOPs, qualification protocols, and reports
Experience with assay development for cell therapy, including for flow cytometry, ddPCR/qPCR and/or ELISA-based assays a plus
Knowledge of ICH guidelines for analytical method development and validation
Industry experience in quality control or analytical development for advanced therapies
Excellent organisational and documentation skills
Excellent multi-tasking, analytical, organisational and leadership skills.
Strong written and verbal communication skills.
Ability to troubleshoot, identify root cause and systematically resolve problems
PhD Cell Biology, Stem Cell Biology or similar; or equivalent research experience
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.
For information on how we will manage your data please see our Candidate Privacy Notice - https://www.bit.bio/privacy