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Senior Director, Commercial Manufacturing & CMC Development

BridgeBio Inc.
San Francisco, United StatesRemotefull_timeVerifiedPosted 28 Jan 2025
💰 $230,000/yr

About the role

About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our investigational product, acoramidis (AG10), is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs. 

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe. 

To learn more about our story and company culture, visit us at eidostx.com/ | https://bridgebio.com

Who You Are

We are seeking a seasoned pharmaceutical leader to guide commercial manufacturing operations and CMC development across all stages of drug substance (DS) and drug product (DP) supply. This individual will leverage a deep background in small-molecule drug discovery, process development, and large-scale commercial manufacturing to ensure reliable product quality, regulatory compliance, and on-time global supply.

Responsibilities

  • Commercial Manufacturing Leadership:
    • Oversee end-to-end commercial manufacturing activities, including supplier selection, technology transfer, and ongoing process optimization for both drug substance and drug product
    • Ensure GMP compliance, robust quality systems, and regulatory readiness to support commercial supply and global product launches
  • CMC Strategy and Execution:
    • Drive the CMC strategy from late-phase development through commercialization, collaborating with cross-functional teams (R&D, Quality, Regulatory, Supply Chain) to ensure seamless integration of manufacturing processes
    • Lead and advise on CMC-related sections for regulatory submissions, ensuring alignment with international health authority expectations
  • Vendor and Partner Management:
    • Manage relationships with CDMOs and raw material suppliers, negotiating contracts, setting performance standards, and overseeing quality and timelines
    • Continuously evaluate the external network, identifying new partners and implementing improvements to enhance cost-effectiveness and supply reliability
  • Team Leadership and Development:
    • Build, mentor, and inspire a high-performing team of CMC professionals, fostering a culture of innovation, accountability, and continuous improvement
    • Provide strategic guidance on talent development and resource planning to support evolving business needs
  • Scientific and Technical Expertise:
    • Apply broad scientific knowledge of chemistry, process R&D, and manufacturing best practices to resolve technical challenges
    • Guide process scale-up, technology transfers, and troubleshooting activities to ensure product consistency and on-target performance

No matter your role at BridgeBio, successful team members are:

  • 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

Education, Experience & Skills Requirements

  • Experience: 15+ years in the pharmaceutical industry, with a focus on sma

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Company

BridgeBio Inc.

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