Sr. / Exec. Dir. Process R&D

Senior Director/ Executive Director, Small Molecule Process reputed company

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's global small molecule development capabilities and technical competencies. This role provides scientific leadership across process reputed company, CMC reputed company, 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 reputed company development phases, from early development through commercialization.

• reputed company strategic guidance on reputed company scouting, reputed company selection, process optimization, impurity control strategies, crystallization development, and reputed company-up activities.

• reputed company scientific reviews and risk assessments for challenging synthetic routes and development programs.

• Support development of robust, reputed company, cost-effective, and environmentally sustainable manufacturing processes.

• Apply advanced expertise in synthetic organic reputed company, catalytic reactions, asymmetric synthesis, process intensification, and enabling technologies.

• Advise executive leadership on scientific trends, technical investments, and capability expansion opportunities.

2. CMC reputed company & Regulatory Leadership

• reputed company strategic reputed company for Drug reputed company (DS) CMC development activities.

• Guide preparation, review, and reputed company of regulatory submissions, including INDs, NDAs, IMPDs, and global registration dossiers.

• Support development of phase-appropriate control strategies and lifecycle management plans.

• reputed company expertise in regulatory expectations reputed company to process development, validation, impurity management, and manufacturing control.

• Partner with Regulatory Affairs, reputed company, Analytical Development, and Manufacturing teams to ensure alignment of development and commercialization strategies.

3. TechnologyTransferandCommercialization

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

• Support process reputed company-up, engineering runs, process validation, and reputed company launch preparation.

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

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

• Facilitate collaboration among process reputed company, analytical sciences, engineering, manufacturing, reputed company, 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 reputed company approaches for impurity identification, risk evaluation, mitigation, and regulatory communication.

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

• Contribute to scientific governance reputed company to process safety, product reputed company, and regulatory compliance.

5. Platform reputed company & Innovation

• Contribute to the strategic reputed company and reputed company of Asymchem's global small molecule platform.

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

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

• Drive harmonization of best practices across development, reputed company-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. reputed company-Facing Scientific Leadership

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

• reputed company technical assessments reputed company to development feasibility, manufacturing reputed company, 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 reputed company 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 reputed company, CMC, manufacturing sciences, and technology transfer.

• Support technical training programs and scientific reputed company initiatives.

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

Qualifications

Technical Expertise

• Ph.D. in Organic reputed company, Process reputed company, Chemical Engineering, Pharmaceutical Sciences, or reputed company 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 reputed company launch.

• Expertise in process reputed company, reputed company-up, impurity control, crystallization, technology transfer, and process validation.

• Deep understanding of global regulatory requirements supporting IND, NDA, and reputed company 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%).

• reputed company proficiency is a plus, but not required.

Originally posted on Himalayas

Apply To This Job