Scientist, Process Development-Upstream

Department
Process Development and Production

Location
San Diego, CA

Summary Description
PaxVax, Inc. is seeking a Scientist to join the Process Development and Clinical Production teams focused on vaccine development from preclinical through Phase III, and commercialization. The Scientist role will focus on the development of upstream cell culture and virus amplification/virus-like-particles transfection with disposable bioreactors, and support of downstream purification with Chromatography method. The primary responsibilities include the design, execution, and documentation of experiments to develop/optimize upstream (bioreactor, transfection, microfiltration, filtration) for clinical supply production and scale up of these processes to enable transfer of robust processes to the commercial space.

Responsibilities:

  • Develop and optimize the cell culture parameters (for various cell lines) and nutrient requirement in shaker flasks and disposable bioreactors (10L, 50L and 200L) for mammalian suspension cell growth for virus and virus like particle production
  • Develop and optimize the viral amplification/virus-like-particle transient transfection process to maximize the yield
  • Develop and optimize the microfiltration process to concentrate the cells for viral amplification/virus-like-particle transient transfection
  • Use DOE software to design the experiment and analyze results for virus/virus-like-particle yield improvement
  • Write technical reports and transfer the method and work with clinical production team to support/generate the SOPs/batch record and produce the clinical trial materials
  • Support investigational new drug (IND) chemistry-manufacturing-control (CMC) section writing
  • Support downstream purification team for the development work (tangential flow filtration, anion exchange chromatography purification and sterile filtration) and clinical trial material production as needed
  • Guide/train junior level associates

Technical Skills and Knowledge:

  • Cell culture experience required
  • Bioreactor experience required
  • Design of Experiment (DoE) is required
  • Electroporation experience is preferred
  • Anion Exchange Purification experience is preferred
  • Diafiltration/Ultrafiltration experience is preferred
  • Good data anaylsis skills
  • cGMP experience is preferred
  • Molecular biology and virology knowledge is preferred
  • Good aseptic techniques

Qualification Requirements:

  • Minimum of 2 years of experience in the mammalian cell culture and bioreactor experience
  • Ph.D. degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or a related field
  • Excellent written and verbal communication skills required.
  • Record of successful publication is a plus

Travel:

Occasional travel

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