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Scientist – Biopharmaceutical Process and Technical Transfer

Scientist – Biopharmaceutical Process and Technical Transfer

CompanyZoetis
LocationLincoln, NE, USA
Salary$Not Provided – $Not Provided
TypeFull-Time
DegreesBachelor’s, Master’s
Experience LevelMid Level, Senior

Requirements

  • Bachelor’s degree in Biochemistry, Biology or Biochemical Engineering
  • 2 – 5 years of Cell culture, Viral or Biopharmaceutical Process Development experience
  • Background in biopharmaceutical tech transfer into commercial facilities
  • In depth knowledge of cell culture and purification processes/ equipment
  • Demonstrated decision-making experience
  • Strong academic and applied experience in science and / or engineering, troubleshooting, and problem solving
  • Independently motivated with successful ability to multi-task and work in teams
  • Excellent written and verbal communication with experience with technical writing and presentations
  • Process optimization and change control experience
  • Knowledge of USDA, FDA, and EU regulatory systems desired
  • Strong technical/analytical skills and possess a high degree of personal motivation
  • Strong commitment to product quality, continuous improvement and working knowledge of RFT (Right First Time) and Lean principles
  • Strong commitment to customer service

Responsibilities

  • Applies advanced and diverse science and engineering principles to the design and implementation of major system modifications, process and/or capital projects.
  • Support clinical and commercial tech transfers of late-stage Zoetis products from laboratories and across manufacturing facilities.
  • Represent drug-substance manufacturing and provide input to development teams.
  • Develop, analyze, and present interpretations of process data for operational issues of significant scope and complexity.
  • Perform complex troubleshooting to assess and correct bio-process equipment malfunctions.
  • Conduct process monitoring and provide technical troubleshooting using sophisticated digital tools. Using this analysis, identify and implement process improvements that lead to yield and capacity improvements.
  • Model commercial bioreactor processes at bench scale as a tool for investigations, tech-transfers, and process improvements.
  • Serve as a subject matter expert of Biopharmaceutical operations including single-use technologies, media and buffers, and commercial scale bioreactors.
  • Author protocols, study reports, SOPs, and other documents in support of process changes/optimization.
  • Provide technical guidance and lead investigations for process related deviations and operational excellence projects.
  • Work within a cGMP environment and maintaining regulatory and quality compliance.
  • Investigate process deviations and conduct root-cause analysis for implementing corrective and preventive actions following cGMP change control.

Preferred Qualifications

  • Master’s degree in Biochemistry, Biology or Biochemical Engineering
  • 5+ years Biopharmaceutical Process Development experience related to upstream biopharmaceutical process development, scale-up principles, and manufacturing of Biopharmaceuticals (cGMP)