Associate Director- Separations, Analytical Method Sciences (AMS)
Core
Lead the AMS Separations organization to deliver quality separations methods and specifications for commercial release and stability testing of biopharmaceutical products.
Role type
Senior leadership IC (Associate Director) in analytical method sciences
Builds
Commercial biologics testing methods, stability testing protocols, and analytical lifecycle management capabilities
Domain
Biopharmaceuticals / Analytical Chemistry / Quality Control
Required skills
Strategic leadership, organizational development, technical expertise in chromatographic/electrophoretic methods (SEC, CEX, CE-SDS, icIEF, peptide mapping, glycan analysis), regulatory dossier authorship, cross-functional partnership, talent development, risk assessment
Preferred skills
Experience in biologics development and commercialization, lifecycle management strategies, GMP/GDP compliance, health authority interaction, change management
Technologies
SEC, CEX, CE-SDS, icIEF, peptide mapping, glycan analysis, SDS-PAGE, UV/Vis
Responsibilities
Define and execute strategic vision for the AMS Separations organization, build organizational capability through talent development and succession planning, provide technical oversight for analytical lifecycle management and validation, partner with Quality Control and Regulatory teams, support regulatory submissions and health authority interactions, coach and develop scientific leaders
Seniority
Senior, hands-on IC with strategic leadership
