Associate / Director, Analytical Development

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Associate / Director, Analytical Development

Associate / Director, Analytical Development

Palo Alto, CA

Description

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.

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

What We Offer

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.

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