Associate Director, Analytical Development (Small Molecule)
Core
Provides scientific and people leadership for an area within Analytical Development and Technical Operations, guiding method development, qualification, validation, transfer, and CMC submissions for small molecule pharmaceuticals from early development through commercialization.
Role type
Senior IC analytical development lead with people management responsibilities
Builds
Analytical methods, control strategies, and regulatory dossiers for drug substances and drug products
Domain
Biopharmaceuticals / Small molecule drug development
Required skills
Analytical method development, qualification, validation, transfer, troubleshooting, ICH/FDA regulatory guidance, CMC regulatory submissions, cGMP requirements, physicochemical characterization of APIs, formulation and process development understanding, external CRO/CMO management, people leadership, strategic planning, cross-functional collaboration
Preferred skills
Emerging internal scientific thought leadership, learning agility, innovative scientific approach evaluation
Technologies
Analytical instrumentation, CMC regulatory systems, stability study platforms
Responsibilities
Recommends scientific and operational direction and translates strategy into tactical plans; Leads analytical development activities including method development, qualification, validation, transfer, and stability studies; Provides technical leadership and solutions to complex analytical challenges; Oversees internal activities and external CRO/CMO partnerships; Partners on design, development, validation, and transfer of analytical methods; Contributes technical expertise to CMC regulatory dossiers; Evaluates analytical data and regulatory documentation for quality and compliance; Supports resource planning and prioritization; Coaches and develops scientific staff
Seniority
Senior, hands-on IC with team leadership
