Associate/Director, Analytical Development

Company Background

GondolaBio is a clinical-stage biopharmaceutical company focused on developing next-generation therapeutics for genetic diseases. Originally launched as BridgeBioX, a subsidiary of BridgeBio, GondolaBio secured $300M in private financing from external investors in 2024 and became an independent company within the BridgeBio ecosystem. The company aims to leverage cutting-edge biological research to create breakthrough medicines addressing high unmet needs across multiple therapeutic areas, including neurology, pulmonology, cardiology, nephrology, and endocrinology. Located on the Stanford Life Sciences campus, GondolaBio fosters a unique hybrid environment where top scientists from around the world collaborate with senior leadership and advisors, blending industry expertise with academic innovation.

To learn more, visit us at gondolabio.com

Who You Are

The Associate Director / Director Analytical Development will report directly to the Executive Director of CMC and will be responsible for providing analytical and bioanalytical strategy for development of small molecule candidates as well as peptides from Phase I through NDA for both drug substances and drug products. This individual will also be responsible for developing strategy and managing the stability programs for both the Drug substance as well as drug product.

Requirements and Responsibilities

• Guide CRO/CDMO to design and perform method development and validation employing phase-appropriate approaches at different stages of development (pre-clinical through Phase 3) for assay, purity and dissolution methodologies, identification of impurity and degradation products, reference standard qualification and physical (solid-state) characterization.
• Develop phase-appropriate quality control strategy for drug substance and drug products.
• Manage product stability study programs.
• Guide CRO to develop and validate GLP bioanalytical methods to support DMPK, Toxicology and clinical studies.
• Author analytical development and validation reports and analytical sections in IND/IMPD and NDA filings
• Precise coordination with QA and Regulatory, as well as other CMC functions, clinical and toxicology, regarding safety-related questions on APIs, components of APIs and formulations and materials used in processing.
• Serve as the Analytical representative in cross functional project teams
• Interface effectively with other disciplines (e.g., Clinical, Nonclinical, Drug Substance, Quality Assurance, and CDMO Quality Control)

Education, Experience & Skills Requirements

• PhD in analytical chemistry with 10 years of analytical development experience in the pharmaceutical industry
• Excellent scientific knowledge in analytical chemistry
• Demonstrate a proven track record of managing CROs and CDMOs, preferably on both analytical and bioanalytical projects, in developing methods and quality control strategy for testing of small molecule drug candidates supporting Phase I to commercial launch.
• Experience in drafting analytical sections of IND/IMPD and NDAs
• Experience in drafting, reviewing and submitting required documentation pertaining to the cGMP and GLP environment.
• A proven track record of implementing phase appropriate quality control strategies.
• Strong knowledge of US FDA, EMEA and ICH guidelines is a must.
• Experience with Peptides a plus
• Experience working in a QC environment a plus
• Travel – up to 10%

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
• An unyielding commitment to always putting patients first.
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision – both for your program and 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
• Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic areas over time · Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion

Salary

The base pay range for this position is $188,000 to $213,000 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.