Scientist, Quality Control (QC)

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:

To enable bit.bio to achieve our goals, we are looking for an experienced Scientist to join our QC team. You will assist with release testing of a wide range of iPSC-derived cell types and clinical programs, together with the optimisation and development of new test methods to improve efficiency and deliver operational excellence.

You will work cross-functionally with teams across bit.bio to help deliver a quality product to market as well as contribute to the continuous development of the QC team, the laboratory environment and overall objectives of bit.bio.

Your key responsibilities will include:
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 method development & QC release testing for clinical programs to ensure testing is executed to the required regulatory standards.
Evaluate data generated to ensure method requirements are met.
Follow Good Laboratory Practice (GLP) to ensure testing details, documentation and lab equipment are maintained and followed to the highest standards.
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.
Support the optimisation and development of release test methods for ioCells and clinical programs and explore opportunities to evaluate new technologies for use in the QC environment, as required.
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.
Support the tech transfer of new cell types entering production & QC from MSAT including training on new techniques, as required.
Actively lead in developing and maintaining the core cultural aspects of bit.bio.
Work environment: 70% laboratory environment, 30% office and meeting room environment.

You…
Have a BSc/MSc in Molecular Biology, Cell Biology, Biological Sciences or similar; or equivalent experience.
Have demonstrable work experience in a QC laboratory and/or Analytical Development laboratory with a good understanding of analytical testing and equipment operation / troubleshooting.
Are detail oriented and experienced in working to SOPs.
Enjoy working in a team in a highly collaborative and cross functional environment.
Are a motivated, pro-active scientist with a positive, can-do attitude and enjoy learning new techniques.
Are a passionate team player with excellent organisational and communication skills.

With essential experience in...
Practical experience and knowledge of relevant test methods including immunocytochemistry (ICC), flow cytometry, ELISA and qPCR/ddPCR.
A cGMP or GLP environment.
Cell culture and aseptic techniques.

...and possibly....
Experience qualifying methods to ICH guidelines.
Have practical experience in cell culture and aseptic technique.
Experience of CAPA, LEAN, Six-Sigma, 5S and/or other systems for optimisation and improvement of laboratory processes.