Scientist, Quality Control (QC)

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.

LAB BASED POSITION

Your role in our team:
To enable bit.bio to achieve our goals, we are looking for a highly motivated and experienced Scientist to join our QC team. You will be responsible for successfully developing and refining assays for subsequent transfer to the QC laboratory to support the release of our ioCell products. This is an exciting opportunity to shape and drive analytical development of Bit Bio’s QC assays with cross functional collaboration with stakeholders across Research, Quality and Process Development teams.
As well as driving analytical development, this multifaceted role will include performing release testing of a wide range of iPSC-derived cell types and contributing to the continuous development of the QC team to improve efficiency and deliver operational excellence.

WITH ESSENTIAL EXPERIENCE IN…

• A CMC role with proven experience of analytical development and or quality control.
• Practical experience and knowledge of relevant test methods including immunocytochemistry (ICC), flow cytometry, ELISA and qPCR/ddPCR.
• Knowledge of ICH guidelines for analytical method development and validation.
• Working in a cGMP or GLP environment.
• Practical experience in cell culture and aseptic techniques.

• Actively lead method development and optimisation of release test methods for ioCells and explore opportunities to evaluate new technologies for use in the QC environment.
• Support the tech transfer of new cell types entering production & QC from MSAT including training on new techniques, as required.
• Author SOPs and method development reports in preparation for method transfer.
• Perform QC release testing of final product for all cell types in the growing bit.bio ioCells portfolio to ensure our products are of the highest quality standard to meet customer needs.
• Support continuous improvement of testing practices including establishing ELN templates, supporting data trending, and performing root cause analysis to identify testing issues and appropriate corrective actions. Key contributor to cross-functional project team meetings to ensure alignment across Production, R&D and commercial teams with the goal of delivering the highest quality products to our customers.
• Actively lead in developing and maintaining the core cultural aspects of bit.bio.
• Work environment: 70% laboratory environment, 30% office and meeting room environment.