Director/Sr. Director, siRNA CMC - Palo Alto - GondolaBio

    GondolaBio
    GondolaBio Palo Alto

    5 days ago

    Description

    Overview


    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.

    Role


    Drive the end-to-end Chemistry, Manufacturing & Controls strategy and implementation for various conjugated siRNA assets in GondolaBio portfolio, owning all safety/quality, technical, and regulatory deliverables from late lead optimization through IND, clinical development, and commercial readiness. Architect phase-appropriate drug substance and drug product plans for subcutaneous and intrathecal oligonucleotides, direct a fully outsourced network of CDMOs, and serve as the single accountable CMC voice in cross-functional governance—ensuring decisions are made quickly, data are rock solid, and patients benefit sooner.

    Key Responsibilities

    • Invent & own the CMC roadmap—from IND-enabling tox supply to late-stage development —aligning with corporate goals and risk/benefit for every program.
    • Lead DS & DP development (process chemistry, formulation, analytical, stability) and ensure seamless tech-transfer, scale-up, and lifecycle management.
    • Oversee CDMOs and critical labs—select, contract, budget, and course-correct—adapting study designs to evolving guidelines, timelines, and resources while enforcing cGMP/ICH quality.
    • Author/defend CMC sections of INDs, IMPDs, NDAs/MAAs; lead health-authority meetings and inspection readiness.
    • Deliver clinical-stage supply: forecast demand, release lots, and troubleshoot deviations to keep trials on track.
    • Integrate fast with cross-functional teams (Toxicology, Regulatory, Clinical Ops, Finance) to turn data into rapid, patient-centered decisions.

    Preferred Education And Experience

    • Ph.D. (or equivalent) in Chemistry, Chemical Engineering, Pharmaceutics, or related field; 10+ years progressive CMC leadership in oligonucleotide biotech/pharma.
    • Demonstrated success taking multiple conjugated siRNA candidates from IND through Phase II or NDA, including full CDMO oversight and regulatory interactions (FDA/EMA).
    • Experience with ex-hepatic oligonucleotide delivery platforms (e.g., extrahepatic tissue targeting, novel conjugates or formulations) is a strong plus.
    • Deep expertise in oligonucleotide process development, DP formulation (SC, IT), analytical method validation, and cGMP supply-chain management.
    • Experience in managing CMOs, scientific collaborations, and contracted R&D.
    • Author of multiple Module 3 (Quality) submissions and responder to health-authority queries.
    • Proven operator in compressed, resource-lean biotech settings where every minute counts.
    • Strong attention to detail, and excellent oral and written communication skills.
    • High-clarity communicator who excels in lean, fast-moving settings.

    Nice-to-Haves

    • Track record building scalable phase-appropriate quality systems and vendor networks.
    • Comfort authoring CMC diligence assessments for in-licensing or M&A opportunities.
    • Experience with accelerated development pathways (Fast Track, Breakthrough, RTOR) a plus.

    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 BridgeBio Pharma programs across multiple therapeutic areas over time.
    • Partnerships with leading institutions.
    • Commitment to Diversity, Equity & Inclusion.

    The base pay range for this position is $240,000 to $290,000 per year. The actual compensation offered will be determined based on several job-related factors, including experience, skills, qualifications, and location. A bonus plan and equity will also be offered.


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