Research Scientist - Analytical Development

Job Summary

Role Summary

We are seeking an enthusiastic individual to work as a Research Scientist in our state-of-the-art laboratories in West London.

The post holder will be highly motivated and will have experience in cell culture techniques and analytical methods such as flow cytometry, ELISA and qPCR. In addition to excellent technical skills, they will have a well-grounded knowledge of cell biology and biotechnology. They will have experience in leading projects, executing experiments, analysing and presenting data. They will closely collaborate with other team members and contribute to the development of processes suitable for manufacture of high-quality cell-based therapeutic products.

Key Responsibilities

• Developing complex, fit-for-purpose biological analytical methods to characterize and release cell therapy products or product intermediates i.e., T cell quantity, purity, % expression of CAR, characterize memory phenotype and other attributes, Lymphocyte subtype characterization, and/or cellular impurities.
• Analytical analysis of cell-based bioassay read-outs, for example cytokine upregulation, surface marker up or down regulation
• Provide analytical support for the process development organization to support process development, process improvement, or investigations
• Collaborate with team members, Team Lead/Principal Scientist to design, execute, and analyse experiments with good attention to details
• Analytical method development and lifecycle support, including critical reagent selection based on the analytical method target profile, and quality target product profile, reagent qualification, instrument and method troubleshooting, fit for purpose method pre-validation, method transfer to Quality Control, deviation investigation support, including unexpected or out of specification results, development of validation protocols and appropriate acceptance criteria
• Support instrument maintenance and calibration
• Maintain relevant databases to ensure appropriate data trending and data tracking
• Training of junior members of team when required
• Maintain accurate and clearly written laboratory notebooks to standard required for legal requirements, regulatory filings, publications, and patent filings
• Authoring and reviewing technical reports supporting method development and/or pre- validation. Documenting complex analyses to determine the root cause for unexpected results
• Author analytical sections of regulatory submissions that support regulatory filings including INDs and BLAs.
• Any other duties as required following consultation with the post holder
• Participate in meetings and discussions sharing results clearly and logically when required
• Perform analytical method transfer to the Quality Control group
• Work with external service providers as required
• Any other duties as required following consultation with the post holder