Sr. / Exec. Dir. Process R&D

Senior Director / Executive Director, Small Molecule Process Chemistry

Reports To: Chief Technology Officer (CTO)

Location: Global (China, Europe and US)

Employment Type: Full-Time

The Senior Director/Executive Director, Small Molecule Process Chemistry serves as a senior scientific and strategic leader responsible for strengthening Asymchem's global small molecule development capabilities and technical competencies. This role provides scientific leadership across process chemistry, CMC strategy, technology transfer, manufacturing readiness, commercialization, and regulatory support.

Key Responsibilities

1. Scientific & Technical Leadership

• Serve as a senior scientific leader and advisor for small molecule API development programs across all development phases, from early development through commercialization.
• Provide strategic guidance on route scouting, route selection, process optimization, impurity control strategies, crystallization development, and scale-up activities.
• Lead scientific reviews and risk assessments for challenging synthetic routes and development programs.
• Support development of robust, scalable, cost-effective, and environmentally sustainable manufacturing processes.
• Apply advanced expertise in synthetic organic chemistry, catalytic reactions, asymmetric synthesis, process intensification, and enabling technologies.
• Advise executive leadership on scientific trends, technical investments, and capability expansion opportunities.

2. CMC Strategy & Regulatory Leadership

• Provide strategic oversight for Drug Substance (DS) CMC development activities.
• Guide preparation, review, and quality of regulatory submissions, including INDs, NDAs, IMPDs, and global registration dossiers.
• Support development of phase-appropriate control strategies and lifecycle management plans.
• Provide expertise in regulatory expectations related to process development, validation, impurity management, and manufacturing control.
• Partner with Regulatory Affairs, Quality, Analytical Development, and Manufacturing teams to ensure alignment of development and commercialization strategies.

3. Technology Transfer and Commercialization

• 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., Europe, and 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 excellent track 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.