Senior 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 Chemistryserves as a senior scientific and strategic leader responsible for strengthening [Asymchem](https://himalayas.app/companies/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\. 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](https://himalayas.app/companies/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](https://himalayas.app/companies/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](https://himalayas.app)