Associate Scientist-Cell Therapy

• San Diego
• On-site

Job Description

Responsibilities :
We are seeking an experienced and motivated Associate Scientist to join the Analytical Development team at the firm. This position works with the PTCC team to develop and/or improve cell-based assays for cell product characterization and release. The Analytical Development Associate Scientist participates in laboratory activities to support process development evaluate and develop new assay methods and perform product characterization for CAR-T cell products. Also involved in assay optimization and standardization and assay transfer to internal or external QC labs. Under the reasonable supervision the role includes performing assay development experiments carefully documenting methods and materials writing SOPs/reports and communicating findings. The ideal candidate has a proven track record of innovation demonstrated skill set and knowledge in process and analytical development and is excited to take on new challenges in a fast-paced and dynamic environment.

• These may include but are not limited to:
  • Develops analytical test method procedures in accordance with relevant guidelines from ICH USP EP for cell therapy product GMP release testing and characterization.
  • Supports analytical routine testing qualification and validation.
  • Evaluates reagents and supplies to meet QC standards
  • Co-authors test methods (SOPs) technical reports and analytical sampling plans
  • Documents laboratory procedures and experiments with great attention to detail in laboratory notebooks
  • Performs assays for process assessment and product characterization
  • Participates in assay transfers to QC and provides lifecycle support
  • Summarize and present scientific data to project teams.
  • Evaluates alternative technologies to create robust and reproducible analytical methods
  • Sets up monitors samples and analyzes cell culture processes
  • Works with R&D teams to gain deeper understanding of the analytical methods for characterization of product critical quality attributes