Director/Senior Director, Analytical Development
Core
Lead the development, qualification, validation, and implementation of analytical methods for preclinical and clinical-stage biopharmaceutical programs.
Role type
Director, Analytical Development
Builds
Analytical control strategies and validated methods for drug substance and drug product
Domain
Biotechnology / Pharmaceutical Development
Required skills
Analytical method development, method qualification, method validation, GMP implementation, peptide analysis, PEGylated molecule analysis, complex biologics characterization, CRO/CDMO management, regulatory submission support (IND/clinical), analytical risk management, HPLC/UPLC, LC-MS, SEC, ion exchange, peptide mapping, spectroscopy
Preferred skills
Peptide/PEG analytical development, comparability testing (505(b)2), growing an analytical development organization
Technologies
HPLC, UPLC, LC-MS, SEC, Ion Exchange, Peptide Mapping, Spectroscopy
Responsibilities
Develop and execute analytical development strategy from preclinical through clinical stages; Define analytical requirements for starting materials, drug substance, and drug product; Lead development, optimization, qualification, and validation of analytical methods for complex molecules; Ensure analytical methods are appropriate for GMP manufacturing and clinical supply; Build and lead the analytical development organization; Manage relationships with analytical CROs, contract laboratories, and CDMOs
Seniority
Director, strategic leadership with hands-on technical expertise
