Director

1. Job Summary

The API Director is responsible for the overall strategic planning and operational management of the Active Pharmaceutical Ingredient (API) business unit. This role oversees the entire lifecycle of API development—from early-stage research and process optimization to commercial manufacturing and regulatory compliance—ensuring alignment with corporate objectives and global quality standards.

2. Key Responsibilities

Strategic Leadership

• Develop and execute the mid-to-long-term strategic roadmap for the API business, including product portfolio expansion, capacity planning, and technology upgrades.
• Identify and evaluate new opportunities in the API market to drive business growth.

R&D and Technical Management

• Lead the process research, route scouting, process optimization, scale-up, and technology transfer for APIs.
• Spearhead troubleshooting of complex technical issues during R&D and manufacturing phases.
• Drive cost-down initiatives and green chemistry projects to enhance efficiency and sustainability.

Manufacturing & Operations

• Oversee daily production operations to ensure on-time delivery and optimal resource utilization.
• Manage budgets, control production costs, and implement continuous improvement plans for yield enhancement and cycle time reduction.
• Ensure strict adherence to EHS (Environment, Health, and Safety) regulations and promote a safety-first culture.

Quality & Compliance

• Establish and maintain a robust Quality Management System (QMS) compliant with GMP, ICH guidelines, and global regulatory standards (NMPA, FDA, EMA).
• Serve as the key leader during internal/external audits, including Regulatory Authority inspections (e.g., FDA Pre-Approval Inspections) and customer audits.

Team & Cross-functional Collaboration

• Recruit, mentor, and lead high-performing teams across R&D, Production, and QA/QC.
• Collaborate closely with Business Development, Regulatory Affairs, and Project Management teams to support client negotiations, RFQ evaluations, and technical due diligence.

3. Qualifications

Education

• Ph.D. or Master’s degree in Organic Chemistry, Medicinal Chemistry, Chemical Engineering, or a related field.
• A Bachelor’s degree with exceptional industry experience may be considered.