Senior Director, Commercial Manufacturing & CMC Development

Senior Director, Commercial Manufacturing & CMC Development 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.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 productEnsure GMP compliance, robust quality systems, and regulatory readiness to support commercial supply and global product launchesCMC 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 processesLead and advise on CMC-related sections for regulatory submissions, ensuring alignment with international health authority expectationsVendor and Partner Management : Manage relationships with CDMOs and raw material suppliers, negotiating contracts, setting performance standards, and overseeing quality and timelinesContinuously evaluate the external network, identifying new partners and implementing improvements to enhance cost-effectiveness and supply reliabilityTeam Leadership and Development : Build, mentor, and inspire a high-performing team of CMC professionals, fostering a culture of innovation, accountability, and continuous improvementProvide strategic guidance on talent development and resource planning to support evolving business needsScientific and Technical Expertise : Apply broad scientific knowledge of chemistry, process R&D, and manufacturing best practices to resolve technical challengesGuide process scale-up, technology transfers, and troubleshooting activities to ensure product consistency and on-target performanceNo matter your role at BridgeBio, successful team members are : Patient Champions, who put patients first and uphold strict ethical standardsEntrepreneurial Operators, who drive toward practical solutions and have an ownership mindsetTruth Seekers, who are detailed, rational, and humble problem solversIndividuals Who Inspire Excellence in themselves and those around themHigh-quality executors, who execute against goals and milestones with quality, precision, and speedEducation, Experience & Skills Requirements Experience : 15 years in the pharmaceutical industry, with a focus on small-molecule development, commercial manufacturing, and CMC leadership. Proven track record in successfully transitioning products from clinical to commercial scaleTechnical Expertise : Deep understanding of API and DP manufacturing, GMP regulations, quality systems, and global supply chain managementLeadership Skills : Demonstrated ability to lead multidisciplinary teams, manage complex projects, and influence strategic decision-making in a matrixed environmentRegulatory Acumen : Direct experience with global regulatory filings, inspections, and compliance standards, including authoring and reviewing Module 3 documentationEducation : Advanced degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field preferredWhy Join BBIO team : You will be part of a team at the forefront of transforming scientific innovation into commercial reality, playing a pivotal role in bringing life-changing therapies to patients worldwide. If you are a strategic leader with a passion for building robust manufacturing capabilities and elevating global operations, we encourage you to apply.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 effortsA culture inspired by our values : put patients first, think independently, be radically transparent, every minute counts, and let the science speakAn unyielding commitment to always putting patients first. Learn more about how we do this hereA 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 scienceA place where you own the vision – both for your program and your own career pathA collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our gameAccess to learning and development resources to help you get in the best professional shape of your lifeRobust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)Flexible PTORapid career advancement for strong performersPotential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over timeCommitment to Diversity, Equity & InclusionAt BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.$230,000 - $275,000 USDApply for this job#J-18808-Ljbffr

Salary : $230,000 - $275,000