Associate/Director, Analytical Development
Listed on 2026-01-12
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Healthcare
Medical Science, Data Scientist
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Associate/Director, Analytical Development
Associate/Director, Analytical Development
Palo Alto, CA
Description
COMPANY BACKGROUND
Gondola Bio is a clinical-stage biopharmaceutical company focused on developing next-generation therapeutics for genetic diseases. Originally launched as Bridge
BioX, a subsidiary of Bridge Bio, Gondola Bio secured $300M in private financing from external investors in 2024 and became an independent company within the Bridge Bio 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, Gondola Bio fosters a unique hybrid environment where top scientists from around the world collaborate with senior leadership and advisors, blending industry expertise with academic innovation.
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
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%
- 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…
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