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 for patients.
Role type
Principal/Associate Scientist, Analytical Development (Late Stage)
Builds
High-quality, innovative medicines for patients
Domain
Pharmaceutical Sciences / Analytical Chemistry / CMC
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method development and validation, Chromatography (LC), Dissolution testing, Mass Spectrometry, XRPD, Particle size analysis, Regulatory document preparation (CMC sections), Statistics, Data sciences, In silico modeling, Stability prediction, GI absorption modeling, Pharmacokinetic modeling, cGMP compliance, ICH guidelines knowledge, Technical mentoring
Preferred skills
Experience with oligonucleotides and peptides, Strategic planning for pipeline development, Cross-functional collaboration, Scientific presentation and publication
Technologies
LC, KF, XRPD, MS spectrometry, In silico modeling tools
Responsibilities
Develop and validate ICH compliant analytical methods for drug substance and products, Implement quality control strategies based on GxP regulations, Prepare regulatory documents and technology transfer documentation, Lead strategic initiatives to increase pipeline productivity, Mentor junior staff and serve as a technical resource
Seniority
Senior, hands-on IC with strategic influence
