Associate/Sr. Associate, Process Development & Clinical Production

Department
Process Development & Clinical Production

Location
San Diego, CA

Summary Description
The Associate/Sr. Associate assists the scientific staff in carrying out research assignments involving a variety of laboratory methods, equipment and procedures. This is an incredible opportunity to join a small but growing clinical stage pharmaceutical company with a bright future. PaxVax, Inc. is seeking an Associate/Sr. Associate, Process Development & Production to join the Process Development and Clinical Production departments. The successful candidate will work as part of a team focused on 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 upstream (bioreactor, transfection, microfiltration, filtration) or downstream processes (chromatography purification, diafiltration/ultrafiltration) for clinical supply production and to scale up these processes to enable transfer of robust processes to the commercial stage. The successful candidate will be able to work in a fast-paced team oriented environment and be able to learn new skills quickly.

Responsibilities:

  • Deep understanding of bio-chemical and physical properties of therapeutic biomacromolecules including but not limited to proteins and nucleic acids
  • Optimize bioreactor operation and process development for mammalian suspension cells
  • Adherent mammalian cell culture and viral amplification in tissue flasks and CellSTACKs.
  • Viral or virus like particle purification by chromatography and ultrafiltration
  • Lyophilization of vaccine product
  • Milling, blending, coating, packaging operation for capsule or tablet product
  • Understanding of the drug product manufacturing process and scale-up considerations
  • Inititiation of SOPs and batch records

Qualification Requirements:

  • Bachelors degree in Science (Biology, Molecular Biology) or related discipline
  • Minimum of 2 years’ relevant industry experience, or MS degree plus the knowledge and skills acquired through 1 years’ relevant industry experience
  • Team player and collaborator, ability to listen and communicate clear and timely manner
  • Cell culture experience and Good aseptic techniques required
  • Bioreactor experience is preferred
  • Anion Exchange Purification experience is required
  • Diafiltration/Ultrafiltration experience is preferred
  • Basic understanding of Universal Precautions and Basic Lab safety
  • Skilled with use of word processing, spreadsheets, graphical and presentation software applications
  • Basic knowledge of laboratory procedures, established techniques, instruments and equipment, GLP or GMP experience is preferred
  • Capable of searching scientific literature to gain information about specific topics
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