Associate Director, Analytical Development
Core
Lead analytical development and quality control strategies for oligonucleotide and small-molecule intermediates across clinical development, registration, and commercialization.
Role type
Senior IC analytical development lead (oligonucleotides/small molecules)
Builds
Drug substance intermediates for clinical and commercial programs
Domain
Biopharmaceuticals / Oligonucleotide therapeutics
Required skills
Analytical method development and validation, Technology transfer, Impurity control strategy, Reference standard management, Regulatory submission support (IND/BLA), Vendor oversight (CDMOs/labs), cGMP/ICH compliance, Chromatography (HPLC/GC), Mass spectrometry, NMR, Stability testing
Preferred skills
Monoclonal antibody or ADC analytical experience, Post-approval regulatory interaction experience, International regulatory experience
Technologies
HPLC, GC, NMR, Karl Fischer, CD, AEX, RP-HPLC, Mass Spectrometry
Responsibilities
Lead analytical development and QC strategies for oligonucleotide and small-molecule intermediates; Develop and approve method transfer/validation protocols; Establish critical quality attributes and specifications; Oversee reference standard program and external lab testing; Lead CMC analytically focused documentation for biologic INDs and BLAs; Partner with QC/QA to oversee cGMP activities and batch release; Manage cross-functional decision-making and program risks.
Seniority
Senior, hands-on IC
