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).
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