Director​/Sr. Director, CMC Oligo

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

Palo Alto, CA

Drive the end‑to‑end Chemistry, Manufacturing & Controls strategy and implementation for various oligonucleotide (ASO, siRNA) assets in Gondola Bio portfolio, owning all safety/quality, technical, and regulatory deliverables from late lead optimization through IND, clinical development, and commercial readiness. You will architect phase‑appropriate drug substance and drug product plans for subcutaneous and intrathecal administered 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.

• 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‑centred decisions.

• 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 oligonucleotide (ASO, siRNA) candidates from IND through >
  
  Phase II or NDA, including full CDMO oversight and regulatory interactions (FDA/EMA).
• 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, excellent oral and written communication skills.
• High‑clarity communicator who excels in lean, fast‑moving settings.

• 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.

• 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.

• 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…