Senior Analytical Development Manager

Job description

About the Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics. The CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Together, we are driving change. Are you ready to make a difference. The Position: The Senior Analytical Development Manager plans and oversees analytical method validation and characterization studies for late-stage oligonucleotide assets and authors/reviews relevant sections of regulatory submissions. Relationships: This position reports to the Director, Analytical Development. Essential Functions: - Responsible for the oversight of development, transfer, and validation of analytical methods for custom phosphoramidite raw materials, oligonucleotide drug substances, and drug products at contract manufacturing organizations (CMOs) ensuring compliance with applicable ICH guidelines - Establish and justify raw material, drug substance, and drug substance specification limits in alignment with regulatory requirements and IND/IMPD filings - Desi...