Process Analytical Scientist

BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Process Analytical Scientist to work for a leading San Diego biotechnology company.

Process Analytical Scientist

This position is on the Cell Therapy Development team. The Process Analytical Scientist will be responsible for development of analytical methods for cell therapy process and product development. 

  • Establish methods for characterization of process and product and final product release for CAR-T product or other cell therapy products
  • Lead the transfer of test methods to collaborators and CMO
  • Lead the development of analytical and functional testing methods for critical raw materials.
  • Assist in developing test methods for clinical sample testing and transfer to third-party CRO
  • Support Quality Control and Quality Assurance as necessary and participate in the technical assessment of Out of Specification and Non-Conforming investigations.
  • Establish and maintain strong collaborative relationships with company’s R&D and Quality Control units
  • Contribute to regulatory filings as requested by Regulatory Qualifications

  • PhD in immunology, microbiology, biology or other related discipline.
  • Minimum of 4 years of industry experience in analytical development for T cells/immune cells. Experience in cell therapy development is a plus.
  • Industry experience with development of analytical methods, such as qPCR, qRT-PCR, ELISA, cell-based potency assays, gel electrophoresis.
  • Experience with multi-colored flow cytometry is highly desired
  • Experience developing assays for Quality Control testing of drug substance or drug product
  • Ability to work in a fast-moving dynamic small company environment.
  • Outstanding written and oral communication skills are essential
  • Ability to present thoughts clearly and concisely to a wide variety of stakeholders including senior management
  • High sense of integrity and professionalism and the ability to work well in a cross functional team environment

  • Location: San Diego
  • Type: Permanent
  • Job ID: BR49786431