Principle Scientist Upstream Biopharmaceutical Process and Technical Transfer
Enable Zoetis’ mission to serve customers by supporting robust processes and innovative technologies using our scientific and engineering expertise.
The role of the upstream bioprocess scientist will provide technical support for complex equipment and Biopharmaceutical processes. Experience in design, qualification, operation, maintenance and improvement of biopharmaceutical equipment and processes will be required to support day to day manufacturing activities as well as to lead process improvement projects and technical transfers. The candidate is expected to work hands-on while providing strong technical leadership and partnering with manufacturing, quality, supply chain, equipment engineering, research and development, and process scientists to produce clinical supply and work toward commercial facility licensure. The position will require a high degree of autonomy in the discipline and work with colleagues in cell culture, bacteriology, virology, formulation and bioanalytical science. To be successful this position will require hands on experience in mammalian bioreactor processes for efficient production of biotherapeutic proteins and a working knowledge of related bioprocessing operations.
- 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 (PAT). 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.
- Mentor junior colleagues and build a positive working relationship with manufacturing colleagues and contractors
- Provide technical guidance and lead investigations for process related deviations and operational excellence projects
- Demonstrate project management skills and application of concepts.
- 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.
Education and Experience
- Master’s degree and 10 years of Biopharmaceutical Process Development experience
- Bachelor’s degree and 15 years of Biopharmaceutical Process Development experience
- Master’s or PhD degree in Biochemistry, Biology or Biochemical Engineering
- 10+ years Biopharmaceutical Process Development experience related to upstream biopharmaceutical process development, scale-up principles, and manufacturing of Biopharmaceuticals (cGMP)
Technical Skills and Competencies Required:
- Background in biopharmaceutical tech transfer into commercial facilities
- In depth knowledge of cell culture and purification processes/ equipment
- Demonstrated leadership skills and 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.
- In depth 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.
- Travel to domestic and international sites may be required <10%
- Gowning into production areas
- Work some weekends due to experimental designs
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