3. TechnologyTransferandCommercialization

• Advise project teams on commercial route selection, manufacturing readiness, and long-term supply strategies.

• Support process scale-up, engineering runs, process validation, and commercial launch preparation.

• Guide technology transfer activities between development and manufacturing organizations across global sites.

• Promote Quality-by-Design (QbD), risk assessment, and science-based decision-making throughout development.

• Facilitate collaboration among process chemistry, analytical sciences, engineering, manufacturing, quality, and supply organizations.

4. Advanced Impurity & Risk Management Leadership

• Serve as a scientific resource for mutagenic impurity control strategies and nitrosamine risk assessments.

• Support internal teams and clients in developing scientifically sound approaches for impurity identification, risk evaluation, mitigation, and regulatory communication.

• Establish best practices aligned with evolving global regulatory expectations for impurity control and lifecycle management.

• Contribute to scientific governance related to process safety, product quality, and regulatory compliance.

5. Platform Strategy & Innovation

• Contribute to the strategic growth and evolution of Asymchem's global small molecule platform.

• Identify emerging technologies, scientific approaches, and operational capabilities that enhance competitiveness and execution excellence.

• Support implementation of innovative technologies, including flow chemistry, biocatalysis, automation, digital development tools, advanced process analytics, and manufacturing sciences.

• Drive harmonization of best practices across development, scale-up, and commercialization activities.

6. Global Technical Integration

• Promote scientific and operational alignment between U.S., Europeand China development organizations.

• Establish consistent approaches to process development, technology transfer, technical documentation, and scientific decision-making.

• Support technical governance and portfolio reviews for strategic programs.

• Facilitate effective communication and collaboration among global stakeholders.

7. Client-Facing Scientific Leadership

• Represent Asymchem as a senior scientific leader during client interactions, technical reviews, and strategic discussions.

• Provide technical assessments related to development feasibility, manufacturing strategy, regulatory risks, and commercialization planning.

• Partner with Business Development and Project Management teams to strengthen proposals, technical narratives, and differentiated service offerings.

• Participate in technical due diligence activities and support evaluation of strategic business opportunities.

• Serve as an executive-level scientific representative during key client meetings and audits.

8. Organizational Development & Mentorship

• Mentor senior scientists, technical leaders, and project teams across the organization.

• Contribute to succession planning and capability-building initiatives in process chemistry, CMC, manufacturing sciences, and technology transfer.

• Support technical training programs and scientific excellence initiatives.

• Foster a culture of innovation, collaboration, accountability, and continuous improvement.

Qualifications

Technical Expertise

• Ph.D. in Organic Chemistry, Process Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related scientific disciplines.

• 15-20+ years of experience in pharmaceutical or CDMO process development and CMC leadership.

• Demonstrated an excellenttrack record of advancing small molecule programs from early development through regulatory approval and commercial launch.

• Expertise in process chemistry, scale-up, impurity control, crystallization, technology transfer, and process validation.

• Deep understanding of global regulatory requirements supporting IND, NDA, and commercial product lifecycle management.

• Recognized expertise in mutagenic impurity and nitrosamine risk management is highly desirable.

• Experience leading multidisciplinary development teams supporting global development and manufacturing operations.
• Ability to operate effectively across global organizations and time zones.
• Willingness to travel internationally as business needs require (approximately 25–35%).

• Mandarin proficiency is a plus, but not required.

Originally posted on Himalayas