Position Summary
Enable Zoetis’ mission to serve customers by supporting robust processes and innovative technologies using our scientific and engineering expertise.
The role of the formulation/lyophilization process scientist will provide technical support for complex Biological and Biopharmaceutical equipment and processes. Experience in design, qualification, operation, maintenance and improvement of equipment and processes will be required to support 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 formulation, lyophilization, adjuvant, and bioanalytical science. To be successful this position will require expertise in formulation and lyophilization processes for biological vaccines and a working knowledge of related bioprocessing operations.
Position 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 manufacturing and provide input to development teams.
- Support formulation and lyophilization drug product processes
- Develops, organizes, analyses, and presents interpretation of results for operational issues of significant scope and complexity.
- Equipment / Process knowledge to perform complex troubleshooting of process, equipment failures or malfunctions and/or the development of technical assessments.
- 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.
- Serve as a process expert of Biological and Biopharmaceutical operations and processes such as single use technologies, media / buffer solution preparation, emulsification and homogenization, particle size analysis, moisture analysis, lyophilization, drug product formulation and drug product filling.
- Author protocols, study reports, and other documents in support of process changes/optimization.
- Mentor junior colleagues and provide direction to manufacturing colleagues and contractors.
- Provide technical guidance and lead investigations for process related deviations, change control and operational excellence projects.
- Demonstrate project management skills and application of concepts.
- Work within a cGMP environment and maintaining regulatory and quality compliance.
- Experience in investigation of deviations, development of corrective and preventive actions and generation and implementation of change controls.
Education and Experience
Basic Qualifications:
- Master’s degree and 10 years of Formulation/Lyophilization Process Development experience
Or
- Bachelor’s degree and 15 years of Formulation/Lyophilization Process Development experience
Preferred Qualifications:
- Master’s or PhD degree in Biochemistry, Biology or Biochemical Engineering
- 10+ years Downstream Process Development experience related to biochemical engineering and/or protein biochemistry, scale-up principles, and manufacturing of Biopharmaceuticals (cGMP)
Technical Skills and Competencies Requirement
- Background in biological tech transfer into commercial facilities
- In depth knowledge of formulation and lyophilization 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.
- Knowledge in French
Physical Position Requirements
- Lifting
- Sitting
- Travel to domestic and international sites may be required <10%
- Standing
- Walking
- Gowning into production areas
- Some weekend work due to experimental design / production schedule.
