Senior Director, Commercial Manufacturing & CMC Development

BridgeBio; San Francisco (CA); On-site; USD 230,000 - 275,000; Full time

Benefits offered by this job

Flexible PTO

Robust compensation & benefits package

Access to learning and development resources

Rapid career advancement for strong performers

Commitment to Diversity, Equity & Inclusion

Job summary

An established industry player is on the lookout for a Senior Director to lead commercial manufacturing and CMC development. This pivotal role requires a deep understanding of small-molecule drug development and a proven track record in transitioning products from clinical to commercial scale. You will oversee end-to-end manufacturing activities, ensuring compliance with GMP regulations while collaborating with cross-functional teams to drive CMC strategies. Join a dynamic team focused on transforming scientific innovation into life-changing therapies for patients worldwide, where your expertise will directly impact the delivery of meaningful medicines. If you are a strategic leader passionate about building robust manufacturing capabilities, this opportunity is perfect for you.

Qualifications

• 15+ years in pharmaceutical industry with focus on small-molecule development.
• Deep understanding of API and DP manufacturing, GMP regulations.

Responsibilities

• Oversee commercial manufacturing activities and ensure GMP compliance.
• Drive CMC strategy from late-phase development through commercialization.

Skills

Leadership in Pharmaceutical Operations

Small-Molecule Drug Development

GMP Compliance

Regulatory Filings and Compliance

Project Management

Education

Advanced degree in Chemistry

Advanced degree in Chemical Engineering

Advanced degree in Pharmaceutical Sciences

Job description

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 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 small-molecule development, commercial manufacturing, and CMC leadership. Proven track record in successfully transitioning products from clinical to commercial scale
• Technical Expertise: Deep understanding of API and DP manufacturing, GMP regulations, quality systems, and global supply chain management
• Leadership Skills: Demonstrated ability to lead multidisciplinary teams, manage complex projects, and influence strategic decision-making in a matrixed environment
• Regulatory Acumen: Direct experience with global regulatory filings, inspections, and compliance standards, including authoring and reviewing Module 3 documentation
• Education: Advanced degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field preferred

Why 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 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. Learn more about how we do this here
• 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
• Commitment to Diversity, Equity & Inclusion

At 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 USD

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