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/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
• 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

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 several years of experience in developing assays for advanced therapies
• 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 cell-based assays; ideally for cell therapy
• Experience in method development and qualification, including writing and reviewing method SOPs, qualification protocols and reports
• Knowledge of GxP principles and regulations 

...and possibly....

• 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