Scientist, Analytical Development (Cell Therapy)

Location: Babraham Research Park, Cambridge

Type: Full time, permanent 

Start: Immediate

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

You…

• 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

...and possibly....

• 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