GondolaBio

Vice President

• Provide executive leadership for Analytical Development, QC, and Stability across all small molecule programs
• Define and implement phase-appropriate analytical strategies from preclinical through commercialization
• Build and scale analytical infrastructure, systems, and teams to support portfolio growth
• Oversee method development, validation, transfer, and lifecycle management
• Lead analytical and CMC strategy for global regulatory submissions, with primary accountability for NDA preparation and submission
• Author and review Module 3 (CMC) sections, including drug substance and drug product analytical components
• Lead responses to regulatory agencies (FDA, EMA, etc.) and represent CMC in health authority interactions
• Ensure alignment of analytical control strategies with regulatory expectations and lifecycle management plans
• Drive analytical activities supporting Phase 2/3 programs, registration batches, and PPQ
• Ensure inspection readiness for pre-approval inspections (PAI) and commercial launch
• Oversee stability programs, shelf-life justification, and comparability strategies
• Direct and oversee multiple CMOs and CROs for analytical development, QC testing, and stability programs
• Establish strong governance, quality oversight, and performance management frameworks
• Lead tech transfer activities and ensure successful execution across external partners
• Partner with Quality to ensure robust analytical QMS, including deviations, OOS/OOT, change control, and audits
• Support internal and external audits and ensure compliance with GMP and global regulatory standards
• Serve as a key member of the CMC leadership team, collaborating with Process Chemistry, Formulation, Regulatory, and Quality
• Support due diligence, partnerships, and alliance management activities
• Provide strategic input on portfolio decisions, timelines, and resource allocation

Vice President, CMC Analytical