Senior 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 Senior Scientist, GMP Analytical Development will be responsible for successfully developing and/or adapting characterisation and release 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 research, translational medicine, 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, new technology evaluation, and development/adaptation of multiple assays, including flow cytometry, PCR, and ELISA-based methods.
The successful candidate will execute key analytical development activities for our first cell therapy product. This is a partly lab based role.
Your key responsibilities will include:
Successfully execute the strategy and objectives for the GMP analytical development function to meet the company’s clinical cell therapy goals in line with business priorities
Lead development of multiple assays for QC release and characterisation testing for a novel engineered cell therapy, including flow cytometry, ddPCR and/or qPCR, and cell-based functional assays
Design lean experiments to drive process and analytical development knowledge, including use of principles of design of experiments (DOE) when applicable
Partner with translational medicine, research teams and process development for adaptation of key assays for QC and in-process testing, as applicable
Author SOPs and method development reports in preparation for method transfer
Collaborate with cross-functional stakeholders for CTO and/or CDMO selection, assay transfer, and relationship management
Hire, coach, mentor and train direct and in-direct reports to build a high-performing and matrixed analytical development team
Interface with quality and regulatory teams to appropriately incorporate current regulations and guidance into the testing approach
This is a hands-on position, requiring some 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 several years of experience in developing assays for advanced therapies
Are able to demonstrate leadership and management skills in clinical therapy programs
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, analytical 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 analytical development for advanced therapies
Experience with the development of flow cytometry and cell-based assays; ideally for cell therapy
Experience in method development and qualification, including writing and reviewing method SOPs, qualification protocols and reports
Experience managing a lab-based team
Experience in managing external vendors
Full knowledge of GxP principles and regulations
Quality compliance standards and risk management
Industry experience developing methods for QC testing of advanced therapies
PhD Cell Biology, Stem Cell Biology or similar; or equivalent research experience
Experience with development of qPCR or ddPCR and/or ELISA based assays
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