Process Development Engineer

2 weeks ago


Thousand Oaks, California, United States Infotree Global Solutions Full time

At Infotree Global Solutions, we are seeking a highly skilled Process Development Engineer to join our Drug Substance Technology Engineering team in Thousand Oaks. As a key member of our team, you will provide process engineering support for human therapeutic products in clinical development through commercial production.

Key Responsibilities:

  • Transfer upstream (cell culture & harvest) drug substance processes and facilitate process improvements from the laboratory into the manufacturing facility.
  • Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operations.
  • Offer process validation support for late stage commercial processes.
  • Provide routine process monitoring and troubleshooting.
  • Execute data trending and statistical process analysis.
  • Support technical direction for process related deviations, CAPAs and change controls.
  • Identify and support process related operational excellence opportunities.

Requirements:

  • Biotech background/experience, plus cell culture and/or purification experience.
  • Strong communication skills, comfortable speaking to a group of 20+ manufacturing associates in presentation.
  • GMP experience highly preferred, with a background in dealing with FDA/inspectors/auditors.

Day-to-Day Responsibilities:

  • Work on cell-based assay development, assay execution, and data analysis.
  • Maintain mammalian cell cultures.

Top 3 Must-Have Skill Sets:

  • Upstream experience.
  • Strong communication skills.
  • GMP experience.

About Us:

Infotree Global Solutions is a leading provider of innovative solutions for the biotech industry. We are committed to delivering high-quality products and services that meet the needs of our customers.



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