POSITION SUMMARY
The Active Pharmaceutical Ingredient (API) Global Manufacturing Technology (GMT) Sustainability Senior Scientist will focus on impurity identification and control driven by regulatory changes including GL10 and REACH, and support product and process sustainability across the portfolio. The ideal candidate will possess a broad expertise in analytical technology and be proficient in small molecule process development. The role will be accountable to develop analytical methods to meet product characterization and quantification goals. In addition, the candidate will provide analytical expertise to support the development of effective process control strategies and/or new manufacturing routes.
The successful candidate will serve as an API SME on the Zoetis Chemical Regulatory Monitoring Steering Committee (CRMSC). As a member of the CRMSC, the candidate will focus on the impact of new chemical regulations on API manufacturing processes. In addition, the candidate will be the primary interface with the Veterinary Medicine Research and Development (VMRD) Clinical Pharmacology and Safety Sciences team.
POSITION RESPONSIBILITIES
1. Conduct laboratory experiments to generate technical data to support scale-up and implementation of API processes into manufacturing focused initially on impurity control or elimination.
2. Support development of a mutagenic impurity control strategy that is based on product and process understanding including a combination of process design and control and appropriate analytical testing.
3. Develop, troubleshoot, and execute a broad range of test methods to characterize mutagenic impurities.
4. Able to collaborate effectively with other team members and analytical experts to deliver results.
5. Apply QbD principles for identification and control of critical process parameters (CPP).
6. Participate in the scale-up and transfer of API processes at commercial scale.
7. Participate in troubleshooting and problem-solving activities across the manufacturing network.
8. Practice good knowledge management practices through documentation and searching internal Zoetis sources as well as external literature.
9. Develop and maintain relationships with colleagues within GMS and VMRD network to identify potential value-creating opportunities for process improvement.
10. Keeps abreast of technological advances specific to process refining techniques, applying new techniques and methods where appropriate.
11. Comply with all safety and quality policies and requirements. Assure that the laboratories maintain a safe and clean working area. Follow cGMP procedures.
EDUCATION AND EXPERIENCE
* BS degree in chemistry or analytical chemistry is required.
* Minimum of 5 years of process chemistry and analytical technologies.
* Mastery of scientific principles, theory, and practice in concert with broad analytical experience.
* Experience in using and interpreting chromatography, spectroscopy, and hyphenated techniques to identify structures is ideal.
* Experience using preparative chromatography would be helpful.
* Familiarity with commercial scale equipment and processes is desired.
* Demonstration of strong skills in organic and analytical chemistry.
* Skilled in applying statistical methods to analytical method performance characteristics.
TECHNICAL SKILLS AND COMPETENCIES REQUIRED
* Effective interpersonal skills. Demonstrated ability to work effectively in cross functional and culturally diverse work environment. The ability to confidently assert a technical position in the face of opposition.
* Foster a productive environment that encourages teamwork and commitment to results.
* Strong understanding of regulatory and quality requirements.
* Proven record of consistent performance.
* Demonstrated capability to effectively apply knowledge, lead multiple activities and balance priorities.
* Commitment to delivering results.
* Ability to develop, execute and document experiments, studies, and projects.
* Demonstrated excellence in planning and organizational skills.
* Comprehensive demonstrated skills in communication (oral and written) - particularly technical writing.
* Strong commitment to safety through personal behaviors, and maintaining a safe and compliant laboratory.
PHYSICAL POSITION REQUIREMENTS
* This position will be located at the Rathdrum API manufacturing site. International travel may be required (~5%).
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