Head of CMC

The Company is seeking a Head of CMC to lead development activities from active pharmaceutical ingredient and formulation development through clinical trial drug manufacturing and regulatory application support. Responsibilities include overseeing CMC operations, designing and guiding experiments, analyzing data, and managing external manufacturing partners, technology transfers, and production schedules. The role also leads investigational drug manufacturing plans, manages internal team members and consultants, and oversees CMC regulatory documentation and responses. Close collaboration with research and development leaders will ensure alignment across nonclinical, clinical, and CMC development, while contributing technical expertise to management decisions. Candidates must have at least seven years of pharmaceutical CMC experience, including small- or medium-molecule API process development, technology transfer and scale-up with contract manufacturers, and preparation of CMC regulatory application documents. A bachelor’s degree in science or engineering, fluent Japanese, and business-level English are required. Experience in formulation development, quality control, smaller organizations, GMP audits, or quality assurance systems is preferred. A relevant doctoral degree and experience with complex compound process development are also advantageous.