Principal Scientist, Process Development & Commercialization

Merck seeks a Principal Scientist to lead process development and commercialization of small molecule pharmaceuticals from late-stage development through commercial manufacturing. The role involves process characterization, technology transfer, regulatory support, and mentoring technical teams while ensuring compliance with cGMP and quality standards.

Responsibilities

• Lead process characterization studies and apply scientific principles to establish robust manufacturing processes
• Develop regulatory filing strategies and support process validation planning and execution activities
• Mentor and develop technical staff through laboratory execution, data analysis, and scientific problem-solving
• Conduct technology transfer activities to external contract manufacturing organizations and commercial sites
• Apply Quality Risk Management and statistical design of experiments to drive data-driven decision making

Requirements

• Bachelor's degree in chemical engineering or related field with 11+ years process development experience, or Ph.D. with 7+ years post-doctorate experience
• Demonstrated expertise in chemical process development, characterization, and scale-up from lab to commercial manufacturing
• Experience leading regulatory filing support activities and process validation planning
• Proven ability to mentor technical staff and lead cross-functional teams toward complex program goals
• Strong technical writing, communication, and project management skills with stakeholder influence capability
• Hands-on laboratory experience with small molecule unit operations: reactions, work-up, isolation, crystallization
• Familiarity with cGMP principles, Quality by Design, statistical experimental design, and process modeling

Compensation: $173,200 - $272,600