Scientist, Product Development

Product Development

San Diego

PaxVax is seeking a formulation scientist or process development scientist to join the Process Development team. The successful candidate will be expected to work as part of a team that is focused on the development of vaccine formulations and process for liquid and powder dosage forms from preclinical through Phase III, and commercialization. The main responsibilities will include the design, execution, and documentation of experiments to develop formulations and process for clinical supply production and to scale up these processes to enable transfer of robust processes to the commercial space. The successful candidate will be able to work in a fast-paced team environment and be able to learn new skills quickly. The candidate at PaxVax will be a key member of the Product Development research team and will report to the Director, Product Development.

Preferred Skills/Experience:

  • Deep understanding of bio-chemical and physical properties of therapeutic biomacromolecules including but not limited to proteins and nucleic acids
  • Liquid formulations for vaccine product or other macromolecular pharmaceuticals
  • Find novel excipients / technology to stabilize vaccine products
  • Lyophilization of vaccine product
  • Milling, blending, coating, packaging operation for capsule or tablet product
  • Scale up experience for liquid and powder fill finish a plus
  • Fill Finish process development and formulation development
  • Understanding of the drug product manufacturing process and scale-up considerations
  • Experience designing, executing, and critically interpreting results from experiments
  • Understanding of molecular interaction with excipients
  • Validation of fill finish powder dosage form
  • CMC strategy
  • Write reports and summarize the data for presentations and regulatory submissions
  • Strong organizational and technical problem solving abilities
  • Perform assay to screen formulations
  • Experience supporting pharmaceutical product development and transfers to clinical manufacturing
  • Cell Culture and cell based assay experience is a plus
  • Ability of effectively prioritizing tasks and managing multiple projects
  • Act as a team player and collaborator who can listen effectively and communicate in an open, clear and timely manner

Qualification Requirements:

  • Minimum of 4 – 6 years of experience in the pharmaceutical formulation or drug product development field
  • PhD 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