Description

We are seeking an outstanding candidate to join our team in San Diego, CA.  The Quality Control Scientist will be responsible for establishing a new QC function at Poseida and ensuring test methods at Poseida’s cell therapy CMOs and third-party testing laboratories are appropriately controlled and qualified, and reviewing analytical data generated by Poseida’s cell therapy CMO.  Primarily, the role will:

  • Assist in the establishing new QC function at Poseida for cellular and gene therapy product testing
  • Provide QC oversight to cell therapy contract manufacturer and third party testing laboratories
  • Participate in developing analytical and functional testing methods.
  • Create and revise Standard Operating Procedures.
  • Author technical reports as necessary and participate in the technical assessment of testing to support production including Out of Specification and Non-Conforming investigations.
  • Establish Poseida’s stability program for raw materials and cell products
  • Establish and maintain strong collaborative relationships with company’s Cell Therapy and R&D units
  • Contribute to regulatory filings as requested by Technical Operations or Regulatory

Poseida Therapeutics is translating best-in-class gene editing technologies into lifesaving treatments. The company is developing CAR T-cell immunotherapies for multiple myeloma and other cancer types, as well as gene therapies for orphan diseases. Poseida has assembled a suite of industry-leading gene editing technologies, including the piggyBac™ DNA Modification System, XTN™ TALEN and NextGEN™ CRISPR site-specific nucleases, and Footprint-Free™ Gene Editing (FFGE).

 Qualifications

Required Experience and Skills:

  • Bachelor of Science degree in chemistry, microbiology, biology or other related discipline.
  • Minimum of 6 years of Quality Control testing experience in cell therapy or biologics manufacturing, or 4 years Quality Control experience with PhD.
  • Experience with cell-based assays. The ideal candidate will have bench experience with cell-based assays.
  • Experience with analytical methods, such as multi-colored flow cytometry, cell-based potency assays, gel electrophoresis, sterility, mycoplasma, endotoxin, and HPLC, in GMP setting. Experience with qPCR and ELISAis a plus
  • Possesses a good understanding of FDA, ICH, and USP regulations and guidelines relating to Quality Control
  • Experience developing assays to be transferred for Quality Control testing of drug substance or drug product is a plus
  • 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