Principal Scientist/ Senior Principal Scientist
Zoetis
4 months ago
On-site
Kalamazoo, MI
Clinical Research and Development
Principal Scientist / Senior Principal Scientist (Process Chemistry)
Position Summary:
- Lead process chemistry innovation, troubleshooting, and optimization of complex chemical syntheses and scale-up, supporting projects from lead candidate identification through commercial process technical transfer.
- Influence strategic direction and ensure alignment with departmental/organizational goals.
- Lead and mentor multi-disciplinary teams; improve productivity and foster cross-functional collaboration.
Essential Duties and Responsibilities:
- Lead process chemistry efforts for novel veterinary therapeutics (design, development, and scale-up).
- Independently design, scale-up, and optimize synthetic processes from mg to multi-kilogram scale.
- Apply green chemistry principles in API process design (safer solvents/reagents, waste minimization, reduced environmental impact, improved efficiency).
- Develop and execute impurity control strategies to ensure product quality, safety, and regulatory compliance.
- Provide technical/scientific leadership and strategic direction across multiple projects.
- Lead technology transfer to commercial manufacturing facilities (safe, robust, economical, environmentally responsible).
- Collaborate with cross-functional teams; advise management on key sensitive/high-impact decisions.
- Prepare and review technical and regulatory documentation (e.g., CMC dossiers, development reports).
- Develop and implement continuous process improvement strategies/tools/technologies.
- Drive digital transformation initiatives in Process Chemistry.
- Champion novel experimental approaches and productivity-enhancing business management tools.
- Mentor and supervise colleagues.
- Represent the chemistry function on global research project teams.
- Support intellectual property strategy for small molecule IP.
Requirements:
- Ph.D. in Synthetic Organic Chemistry; 8+ years industry experience in pharmaceutical or veterinary medicine process chemistry R&D; 2+ years leadership experience managing teams/projects.
- Broad expertise in modern synthetic organic chemistry; strategic/innovative problem-solving.
- Proficiency in chemical literature searching (e.g., SciFinder, Reaxys) and characterization/spectral analysis (HPLC, GC, NMR, UV, LC-MS).
- Hands-on process chemistry scale-up experience, including multi-kilogram API manufacturing and technology transfer.
- Experience with technical/operational risk assessments (e.g., process robustness/FMEA, mutagenic impurities, nitrosamines, PFAS, E&L).
- Excellent written/verbal communication; ability to influence teams, external partners, and management.
- Working knowledge of ICH guidelines and cGMP requirements.
- Knowledge of process safety regulations (e.g., OSHA, REACH) for chemical manufacturing and API processes.
- Experience with automated laboratory reactors, data-rich experimentation, DOE, and QbD.
- Experience in global environments and with contract organizations (CROs/CMOs/CDMOs).
- Knowledge of small molecule IP strategies and filings.
Preferred/Plus Qualifications:
- Post-doctoral experience.
- Experience in animal health / veterinary medicine drug development.
- Experience with continuous flow manufacturing processes.
- Experience with data analytics, digital transformation, and AI/ML in Process Chemistry.
Position Summary:
- Lead process chemistry innovation, troubleshooting, and optimization of complex chemical syntheses and scale-up, supporting projects from lead candidate identification through commercial process technical transfer.
- Influence strategic direction and ensure alignment with departmental/organizational goals.
- Lead and mentor multi-disciplinary teams; improve productivity and foster cross-functional collaboration.
Essential Duties and Responsibilities:
- Lead process chemistry efforts for novel veterinary therapeutics (design, development, and scale-up).
- Independently design, scale-up, and optimize synthetic processes from mg to multi-kilogram scale.
- Apply green chemistry principles in API process design (safer solvents/reagents, waste minimization, reduced environmental impact, improved efficiency).
- Develop and execute impurity control strategies to ensure product quality, safety, and regulatory compliance.
- Provide technical/scientific leadership and strategic direction across multiple projects.
- Lead technology transfer to commercial manufacturing facilities (safe, robust, economical, environmentally responsible).
- Collaborate with cross-functional teams; advise management on key sensitive/high-impact decisions.
- Prepare and review technical and regulatory documentation (e.g., CMC dossiers, development reports).
- Develop and implement continuous process improvement strategies/tools/technologies.
- Drive digital transformation initiatives in Process Chemistry.
- Champion novel experimental approaches and productivity-enhancing business management tools.
- Mentor and supervise colleagues.
- Represent the chemistry function on global research project teams.
- Support intellectual property strategy for small molecule IP.
Requirements:
- Ph.D. in Synthetic Organic Chemistry; 8+ years industry experience in pharmaceutical or veterinary medicine process chemistry R&D; 2+ years leadership experience managing teams/projects.
- Broad expertise in modern synthetic organic chemistry; strategic/innovative problem-solving.
- Proficiency in chemical literature searching (e.g., SciFinder, Reaxys) and characterization/spectral analysis (HPLC, GC, NMR, UV, LC-MS).
- Hands-on process chemistry scale-up experience, including multi-kilogram API manufacturing and technology transfer.
- Experience with technical/operational risk assessments (e.g., process robustness/FMEA, mutagenic impurities, nitrosamines, PFAS, E&L).
- Excellent written/verbal communication; ability to influence teams, external partners, and management.
- Working knowledge of ICH guidelines and cGMP requirements.
- Knowledge of process safety regulations (e.g., OSHA, REACH) for chemical manufacturing and API processes.
- Experience with automated laboratory reactors, data-rich experimentation, DOE, and QbD.
- Experience in global environments and with contract organizations (CROs/CMOs/CDMOs).
- Knowledge of small molecule IP strategies and filings.
Preferred/Plus Qualifications:
- Post-doctoral experience.
- Experience in animal health / veterinary medicine drug development.
- Experience with continuous flow manufacturing processes.
- Experience with data analytics, digital transformation, and AI/ML in Process Chemistry.