Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

QUALIFICATIONS AND KEY SUCCESS FACTORS

• Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline; 15+ years of industry experience with increasing responsibility in process development and CMC leadership.
• Demonstrated success leading API strategy from development through commercialization, including experience with regulatory filings (IND, IMPD, NDA/MAA).
• Deep knowledge of US and EU cGMP requirements and emerging trends in process chemistry and manufacturing technologies.
• Strong record of vendor management, tech transfer, and external partnership leadership across global networks.
• Experience working with oligonucleotides and small molecules preferred.
• Proven ability to influence across functions and levels, integrating technical, regulatory, and business perspectives.
• High ownership, scientific rigor, and strategic agility—able to thrive in a dynamic, mission-driven environment.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You’ll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• Serve as the strategic lead for Process Chemistry across multiple programs and phases, ensuring coherent and forward-looking plans for API development, manufacturing, and regulatory success.
• Lead design, development, scale-up, and technology transfer of drug substance processes, including evaluation and implementation of enabling technologies (e.g., continuous manufacturing, biocatalysis).
• Drive API form selection, CMC strategy, and regulatory documentation from IND through commercial filings.
• Partner with Formulations, Analytical, Quality, Regulatory, and Clinical Supply to deliver on end-to-end CMC execution and risk mitigation.
• Build, manage, and mentor a high-performing internal and external technical team (CRO/CDMO partners), ensuring performance and accountability.
• Shape Praxis’ approach to external manufacturing, including vendor selection, contract negotiation, and governance.
• Translate business and regulatory requirements into technical strategy—ensuring speed, scalability, and compliance.
• Provide thought leadership in process chemistry innovation and represent Praxis at scientific and regulatory forums as needed.