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 Campus, Cambridge
Type: Full time, permanent / Start: Immediate
Salary: Competitive / Hours: 40 p/w
Lab Based Position
Your role in our team:
Reporting to the Director, Analytical Development & QC, the Senior Scientist will be responsible for supporting 3rd party GMP testing for cell banks, 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 - CTO selection, thorough data evaluation, and partnership with analytical development and external partners for assay transfer and qualification.
Your key responsibilities will include:
- Participate in selection of CTOs for a variety of compendial and product-specific analytical methods required for testing of cell banks, 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.
- Lead method development, transfer and qualification/validation of multiple assays for QC release for a novel engineered cell therapy, including flow cytometry, ddPCR and/or qPCR, and cell-based functional assays.
- Support external QC activities including data analysis, validation report review and stakeholder management.
- Collaborate with cross-functional external and internal partners for relationship and lifecycle management to support a successful clinical program.
- Hire, coach, mentor and train direct and indirect reports.
- 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 CMC professional, with significant industry experience, including demonstrable experience in quality control and/or analytical development for advanced therapies.
- Have demonstrable leadership skills in coaching and mentoring direct and indirect reports.
- Have demonstrable success of working effectively in complex matrix project team environment including external partners.
- Are results oriented; with demonstrable creative problem-solving skills under resource constraints and time pressure; able to apply innovative thinking to problem solving for novel challenges.
- Are an outstanding communicator across all levels within an organisation; strong influencing and negotiation skills.
With essential experience in...
- Knowledge and in-depth understanding of ICH guidelines for analytical validation, and corresponding experience with phase-appropriate method qualification or validation.
- Strong technical writing skills, including writing method SOPs and validation protocols and reports.
- Managing CTOs and CDMOs, including experience with technology transfer and management of third party validation.
- Working within a GxP based laboratory setting.
- Excellent organisational and documentation skills.
- Experience with flow cytometry and cell based assays.
- Experience with qPCR or ddPCR.
- Familiarity with testing including safety testing as per USP/JP/EP and applicability of each compendia.
- Experience with development of regulatory guidance packages, and MHRA requirements.