Director, Analytical Development
Core
Leading analytical development for novel NCEs, peptides, and biologic products from clinical through commercial manufacturing.
Role type
Director, Analytical Development
Builds
Industry-leading analytical methods, characterization packages, control strategies, and regulatory filing packages.
Domain
Pharmaceutical/Biotech (Immunology, Oncology, Neuroscience)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Physical characterization, structural elucidation, biopharmaceutics modeling, regulatory agency interaction, NDA/BLA experience, team leadership (20-30 staff), cross-functional partnership, process development strategy, lab automation, digitalization
Preferred skills
None explicitly stated as preferred, only required
Technologies
Chromatography, spectroscopy, physiologically based biopharmaceutics modeling, lab automation systems
Responsibilities
Provide strategic guidance and talent development for analytical scientists; develop and validate analytical methods; establish analytical capabilities for process development and technology transfer; solve complex technical issues in drug release and product performance; manage regulatory interactions and filing packages; lead matrix teams across multiple disciplines; ensure compliance with EHS regulations.
Seniority
Director, strategic leadership & large team management