Strategic SME for analytical development and CMC to support filings (IND/NDA/MAA)
Lead development, qualification, and lifecycle mgmt of analytical methods per ICH
Ensure robust, compliant analytical control strategies enabling clinical progress
Collaborate with Manufacturing, Process Dev, Regulatory CMC and QA on global standards
Lead development activities: programs, characterization, comparability, stability
Manage GMP testing for materials/products; oversee external labs/CDMOs

🎯 Requirements

Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry (preferred)
10+ years in pharma/biotech analytical development with global experience
IND/NDA/MAA submissions; stage-gate strategies; health authority interactions
Chromatography (HPLC/UPLC/GC); Mass spectrometry; stability studies
Method development/validation/transfer; AD/QC in CMC docs
GMP systems: Veeva, LIMS, Empower; leadership and regulatory acumen

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