Principal or Associate Scientist, Analytical Development Japan (Late Stage), Pharmaceutical Sciences
Core
Lead analytical method development, qualification, and validation for late-stage synthetic molecule drug substances and products to ensure high-quality medicines.
Role type
Principal or Associate Scientist, Analytical Development (Late Stage)
Builds
High-quality, innovative medicines for patients
Domain
Pharmaceutical Sciences / Analytical Chemistry
Required skills
Analytical method development and validation, Chromatography (LC), Dissolution testing, Mass Spectrometry, XRPD, Particle size analysis, Regulatory compliance (ICH, FDA, EMA, PMDA), cGMP, Statistics, Data sciences, In silico modeling, Technical mentoring
Preferred skills
Experience with late-stage assets, Cross-functional collaboration, Strategic planning
Technologies
LC, Dissolution, KF, XRPD, MS spectrometry
Responsibilities
Develop and validate ICH compliant analytical methods for drug substance and products; Contribute to pipeline development and strategic discussions; Prepare technology transfer and regulatory CMC documentation; Interpret complex experimental data and integrate multi-disciplinary data; Mentor junior staff and serve as a technical resource
Seniority
Senior, hands-on IC with strategic influence
