Scientist, Process Development-Downstream

Department
Process Development and Production

Location
San Diego, CA

Summary Description
This is an incredible opportunity to join a small but growing clinical stage pharmaceutical company with a bright future. PaxVax, Inc. is seeking a Scientist to work as part of the Process Development and Clinical Manufacturing teams whose primary focus is the development of downstream purification of virus/virus-like-particles with Ultrafiltration/diafiltration, Chromatography purification, and filtration methods. The Scientist role is focused on the process development for vaccine development from preclinical through Phase III, and commercialization. The main responsibilities will include the design, execution, and documentation of experiments to develop/optimize downstream processes (chromatography, purification, diafiltration/ultrafiltration) for clinical supply production and to scale up these processes enabling transfer of robust processes to the commercial space. The successful candidate will work in a fast-paced team oriented environment learning new skills quickly.

Responsibilities:

  • Develop and optimize downstream purification process for virus and virus-like-particles which includes:
    • Tangential flow filtration
    • Chromatography purification
    • Sterile filtration
  • Use DOE software to design the experiment, analyze the results for the virus/virus-like-particle yield improvement
  • Write technical reports, transfer the method and work to the clinical production team, support/generate the SOPs/batch record, and produce clinical trial materials
  • Support upstream cell culture and bioreactor as needed
  • Support investigational new drug (IND) chemistry-manufacturing-control (CMC) section writing
  • Mentor and train junior level associates

Qualification Requirements:

  • Minimum of 2 years of experience in the large molecular (virus or virus-like particle) purification experience
  • Ph.D. degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or a related field
  • Design of Experiment (DoE) is necessary
  • Anion Exchange Purification experience is necessary
  • Diafiltration/Ultrafiltration experience is necessary
  • Cell culture experience is preferred.
  • Electroporation experience is preferred
  • Bioreactor experience is preferred
  • Excellent data anaylsis skills
  • cGMP experience is preferred
  • Molecular biology and virology knowledge is preferred
  • Excellent aseptic techniques
  • Excellent written and verbal communication skills
  • Record of successful publication is a plus

Travel:

Occasional

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