Associate Director, Antisense Oligonucleotide Analytical Development
Core
Lead analytical development for Antisense Oligonucleotide (ASO) drug substances and products, establishing methods, control strategies, and regulatory content.
Role type
Senior IC analytical development lead (ASO)
Builds
ASO drug substance and drug product analytical methods and control strategies
Domain
Biopharmaceuticals / Antisense Oligonucleotides
Required skills
ASO analytical development, method development, validation, transfer, stability, characterization, comparability, specification setting, regulatory CMC, cross-functional leadership, team management, budget planning
Preferred skills
GMP manufacture support, advanced analytical technologies, CRO/CDMO management, regulatory filings, analytical automation, scientific publications
Technologies
Electronic laboratory systems, data analytics
Responsibilities
Lead day-to-day analytical development for ASO programs, develop and implement phase-appropriate analytical methods, provide technical leadership for strategy and lifecycle management, author regulatory submission content, oversee outsourced analytical work, manage and mentor scientific staff, develop strategic roadmap for the function
Seniority
Senior, hands-on IC with management responsibilities
