Senior Associate/Principal Associate, Process Development

Department
Process Development

Location
San Diego, CA

Summary Description
The main responsibilities will include the design, execution, and documentation of experiments to develop/optimize upstream (bioreactor, transfection, microfiltration, filtration) 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. This position will report to the Sr. Scientist/Manger, Process Development.

Responsibilities:

  • Deep understanding of bio-chemical and physical properties of therapeutic biomacromolecules including but not limited to proteins and viral-like particles
  • Optimize mammalian cell culture and viral amplification in 10L to 200L bioreactor
  • Understanding of the drug product manufacturing process and scale-up considerations
  • Optimize transient transfection process to improve product yield
  • Author process development summary and tech reports
  • Author manufacturing SOPs and batch records

Qualification Requirements:

  • Bachelors of Science/engineering in Biology, chemistry, chemical engineering, or related discipline
  • Minimum of 6 years’ relevant industry experience, or MS degree plus the knowledge and skills acquired through 3 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/required
  • Diafiltration/Ultrafiltration experience is preferred
  • Familiar with design of experiment
  • 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
  • Demonstrate an ability to think and act independently; accept supervision, work quickly and accurately in a fast-paced environment, critically analyze data and proactively solve problems

Travel:

  • None
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