Poseida Therapeutics, Inc. is seeking an exceptional candidate to join our Cell Therapy Development team in San Diego, CA. The Process Analytical Scientist will be responsible for development of analytical methods for cell therapy process and product development. Primarily, the role will:
- 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
- Drive the development of QC-friendly late-stage product release assays and new analytical methods to improve understanding of Poseida’s products
- Lead the development of analytical and functional testing methods for Poseida’s 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
Required Experience and Skills:
- PhD in immunology, microbiology, biology or other related discipline.
- Minimum of 4 years of industry experience in analytical development for recombinant protein or viruses. 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
Poseida Therapeutics is translating best-in-class gene engineering technologies into lifesaving cell therapies. The company is developing CAR T-cell immunotherapies for multiple myeloma, prostate and other cancer types, as well as gene therapies for orphan diseases. P-BCMA-101 is Poseida’s lead CAR-T therapy currently in Phase 1 clinical development for the treatment of multiple myeloma. Poseida has assembled a suite of industry-leading gene engineering technologies, including the piggyBac™ DNA Modification System, TAL-CLOVER™ and Cas-CLOVER™ site-specific nucleases, and Footprint-Free™ Gene Editing (FFGE). For more information, visit www.poseida.com.