Position Summary:
The Principal Scientist / Senior Principal Scientist is an experienced scientific leader within process chemistry, responsible for innovating, troubleshooting, and optimizing complex chemical syntheses and scale-up processes, from lead candidate identification through commercial process technical transfer. Leads multi-disciplinary teams, designs and executes complex experiments/projects, influences strategic direction, and ensures alignment with departmental/organizational goals.
Essential Duties and Responsibilities:
- Lead process chemistry efforts: design, development, and scale-up of chemical syntheses for veterinary therapeutics.
- 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, minimize waste, reduce environmental impact, improve efficiency).
- Develop and execute impurity control strategies to ensure product quality, safety, and regulatory compliance.
- Provide strategic direction across multiple projects; act as scientific/technical resource.
- Lead technology transfer to commercial manufacturing facilities (safe, robust, economical, environmentally responsible).
- Collaborate cross-functionally; make recommendations to management on key high-impact decisions.
- Prepare/review technical and regulatory documentation (e.g., CMC dossiers, development reports).
- Implement continuous process improvement and support digital transformation in Process Chemistry.
- Mentor and supervise colleagues; represent chemistry function on global project teams.
- Contribute to small molecule IP strategy (protection and filings).
Requirements:
- Ph.D. in Synthetic Organic Chemistry; 8+ years industry experience in pharmaceutical/veterinary process chemistry R&D; 2+ years leadership.
- Expertise in modern synthetic organic chemistry; SciFinder/Reaxys; HPLC/GC/NMR/UV/LC-MS.
- Hands-on experience scaling up and technology transfer (multi-kilogram API).
- Risk assessment experience (e.g., FMEA, mutagenic impurities, nitrosamines, PFAS, E&L).
- Communication skills; influence project teams/partners/management.
- ICH guidelines and cGMP knowledge.
- Process safety/regulatory knowledge (e.g., OSHA, REACH).
- Automated reactors, data-rich experimentation, DOE, QbD.
- Global collaboration; experience with CROs/CMOs/CDMOs.
- Knowledge of small molecule IP strategies.
Preferred/Plus Qualifications:
- Post-doctoral experience.
- Animal health/veterinary drug development experience.
- Continuous flow manufacturing experience.
- Data analytics/digital transformation; AI/ML in Process Chemistry.