Senior Associate/Principal Associate, Process Development Upstream

Department
Process Development & Production

Location
San Diego, CA

Summary Description
This is an incredible opportunity to join a pharmaceutical company with a bright future. The Associate will be responsible for production of viral and viral like particle vaccines, including adherent and suspension cell culture in bioreactor, infection/transfection, purification and ultrafiltration/diafiltration processes. 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 directly to the Manager, Process Development and Production .

Responsibilities:

  • Perform adherent and suspension mammalian cell culture using disposable technolgies
  • Perform bioreactor operation and process development for mammalian suspension cells
  • Perform viral or virus like particle purification by chromatography and ultrafiltration
  • Perform lyophilization, encapsulation and capsule coating
  • Author process development summary and tech reports
  • Author manufacturing SOPs and batch records
  • Design and execute studies to optimize viral and virus like particle vaccine production yeilds and stability
  • Optimize mammalian cell culture and viral amplification in 10L to 200L bioreactor
  • Lead and present projects within group as well as within the company

Requirements:

  • Bachelors of Science/engineering in Biology, Chemistry, Chemical Engineering, or related discipline
  • Minimum of 5-6 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 in a clear and timely manner
  • Cell culture experience and strong aseptic technique
  • cGMP experience
  • Strong organizational and technical problem solving skills
  • Demonstrated ability to think and act independently; accept supervision, work quickly and accurately in a fast-paced environment, critically analyze data and proactively solve problems

Preferred Qualifications:

  • Experience working with bioreactors, both rocker and/or stir tank
  • Diafiltration/Ultrafiltration experience
  • Design of Experiment experience, JMP software
  • Understanding of the drug product manufacturing process and scale-up considerations

Travel:

10%

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