Associate Director, Small Molecule Analytical Development
Core
Provide scientific and people leadership for analytical development activities supporting small molecule programs from early clinical development through late-stage registration and commercialization.
Role type
Senior IC/Lead small molecule analytical development manager
Builds
Analytical methods, control strategies, and supporting data packages for small molecule therapeutics
Domain
Pharmaceutical small molecule development
Required skills
small molecule analytical development, chromatographic method development, spectroscopic method development, method validation, method transfer, impurity profiling, stability strategy, specification setting, regulatory CMC submissions, cross-functional CMC project leadership, scientific staff management, mentoring, technical communication
Preferred skills
early to late-stage program support, impurity identification and control, degradation pathway assessment, mass spectrometry, NMR, solid-state characterization, dissolution, external partner management (CROs/CDMOs), digital analytical workflows, automation, electronic laboratory systems, scientific publications
Technologies
chromatography, spectroscopy, mass spectrometry, NMR, electronic laboratory systems
Responsibilities
Lead analytical development activities including method development, qualification, validation, transfer, and lifecycle management; Develop and implement analytical control strategies for critical quality attributes; Provide technical guidance for impurity identification, characterization, forced degradation, and stability strategy; Represent the function on cross-functional CMC project teams; Author and review analytical content for regulatory submissions; Collaborate with process chemistry, engineering, quality, and manufacturing teams; Oversee analytical activities conducted by external organizations; Manage, mentor, and develop scientific staff; Evaluate and implement analytical technologies and automation tools; Represent the function in scientific presentations and industry forums
Seniority
Senior, hands-on IC with management responsibilities
