Senior Scientist, Chemical Development

Role: Senior Scientist, Chemical Development, supporting late-stage small molecule drug substance development and manufacturing within a biopharma setting. Responsibilities: drive tech transfer, scale-up, process optimization, and oversee CDMO activities; provide technical guidance; review cGMP documents; contribute to regulatory filings (IND/IMPDs, NDAs/MAAs); implement process improvements; address process chemistry issues in the lab; ensure compliance with cGMP and ICH standards; collaborate with cross-functional teams; manage external vendors/CDMOs. Requirements: PhD in Organic Chemistry, Chemical Engineering, or related; minimum 5 years' experience in small molecule drug substance development, including external vendor management or 8+ years' experience; expertise in late-stage drug transfer; familiarity with control strategies, QbD principles, and regulatory documentation. Preferred: bilingual Japanese/English, strong communication, presentation, problem-solving, and organizational skills; ability to travel domestically and internationally (up to 25%). High-value specifics: focus on small molecules, late-stage development, regulatory filings, cGMP, ICH, global manufacturing support, and cross-cultural collaboration. Work setup: on-site with international travel.