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


Summary:
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. 

Responsibilities:
  • 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

Requirements:
  • 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