Principal or Associate Scientist, Analytical Development Japan (Late Stage), Pharmaceutical Sciences
On-site · Fujisawa, Kanagawa, Japan
Job Summary
Lead the development, qualification, and validation of analytical methods for drug substance and drug products (synthetic molecules) in a phase-appropriate, ICH-compliant manner. Develop and implement strategies to control quality of drug substances/products in collaboration with commercial functions; coordinate technology transfer documentation and regulatory CMC sections; serve as a subject-matter expert in analytical technologies (dissolution, chromatography, MS, etc.) with statistical/data-science and in silico modeling capabilities for analytical development, stability prediction, and pharmacokinetic modeling. Build partnerships with CTOs, CDMOs, and Takeda’s R&D/commercial teams; contribute to regulatory knowledge (FDA/EMA/PMDA/ICH); deliver rigorous scientific experiments and data; prepare technical/project reports and presentations; lead strategic initiatives to increase pipeline productivity and technical capabilities; participate in department priority setting; mentor junior staff and act as a technical resource across Pharm Sci.
Required Qualifications
- Bachelor’s, Master’s or PhD in Chemistry, Engineering, Biology, Analytical Chemistry or related Pharmaceutical Science with 7+ years experience (Bachelor’s); 5+ years (Master’s); 3+ years (PhD) in cGMP pharmaceutical development for synthetic molecules; extensive experience in analytical technologies (LC, dissolution, KF, particle size, XRPD); experience in method development, validation (ICH) and transfer; ability to design analytical strategy; data analysis with statistics/data science/in silico modeling; proven regulatory documentation experience (FDA/EMA/PMDA); ability to mentor junior staff; strong communication and project-management skills; strong publication/presentation track record.
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