About GondolaBio

GondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister company to BridgeBio, originally carved out in 2024 after securing $300M in private financing from external investors. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.

Who You Are

We are seeking an experienced and strategic Vice President of CMC Analytical to lead analytical development and quality control activities for several subsidiary companies, from early development through late-stage clinical programs and NDA submission.

This role will be responsible for building and leading a high-performing analytical organization, driving CMC regulatory strategy, and ensuring inspection readiness and successful global filings. The ideal candidate brings deep expertise in analytical chemistry, strong regulatory authorship experience (IND ? NDA), and a proven track record of managing CMOs and cross-functional teams in a fast-paced biotech environment

Key?Responsibilities

Analytical & CMC Leadership

• 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 

Regulatory Strategy & NDA Execution

• 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 

Late-Stage Development & Commercial Readiness

• 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      

External & CMO Management

• 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 

Quality Systems & Compliance

• 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 

Cross-Functional & Executive Leadership

• 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

Qualifications

Education

• Ph.D. or M.S. in Analytical Chemistry, Chemistry, Biochemistry, or related field      

Experience

• ~15+ years of industry experience in analytical chemistry within pharma/biotech      
• Significant  leadership experience (Director/Sr. Director/VP level) managing teams and  departments 
• Demonstrated  success advancing small molecule programs from early development through  Phase 3 and NDA submission 
• Deep experience in CMC regulatory strategy and authorship (IND, IMPD, NDA) 
• Proven track record of leading analytical contributions to successful regulatory filings and agency interactions 
• Extensive experience managing CMOs and global external networks 

Technical Expertise

• Stron background in analytical method development, validation, and transfer (IC  guidelines) 
• Experience with a broad range of analytical techniques (e.g., HPLC, GC, dissolution, spectroscopy, solid-state characterization) 
• Expertise in stability program design and shelf-life determination 
• Familiarity with GMP quality systems and regulatory compliance requirements

Leadership & Core Competencies

• Strategic thinker with the ability to operate hands-on when needed 
• Proven ability to build and lead high-performing teams and organizations 
• Strong cross-functional collaboration and communication skills 
• Experience operating effectively in small, fast-paced biotech environments 
• Demonstrated success in managing multiple programs, priorities, and external partners

No matter your role at GondolaBio, successful team members are

• · Patient Champions, who put patients first and uphold strict ethical standards
• · Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• · Truth Seekers, who are detailed, rational, and humble problem solvers
• · Individuals Who Inspire Excellence in themselves and those around them
• · High-quality executors, who execute against goals and milestones with quality, precision, and speed

What We Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• A place where you own the vision for your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Commitment to Diversity, Equity & Inclusion 

The base pay range for this position is $320,000 to $364,000 per year. The actual compensation offered will be determined based on a number of job-related factors, including experience, skills, qualifications, and location. A bonus plan and equity will also be offered.