Scientist – Biopharmaceutical Process and Technical Transfer
| Company | Zoetis |
|---|---|
| Location | Lincoln, NE, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s |
| Experience Level | Mid 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)