Sr. Scientist/principal Scientist Formulation/lyophilization… Manufacturing
il y a 3 semaines
Position Summary
Enable Zoetis’ mission to serve customers by supporting robust processes and innovative technologies using our scientific and engineering expertise.
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.
- 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
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