Job Description
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 todiscover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseasesand 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.
The ideal candidate will have 8+ years of experience in the pharmaceutical industry with at least five years of relevant experience in a Chemistry, Manufacturing, and Controls (CMC) organization, including significant experience in a cross-functional team environment. Responsible for the oversight of commercial drug product manufacturing at contract manufacturing organizations while facilitating global commercial drug product disposition. You will also work with colleagues in CMC, Supply Chain Operations, Quality Assurance and CMC-regulatory Affairs, while serving as an important point of technical contact between BridgeBio and contract manufacturing organizations.
Responsibilities
- Person-in-plant oversight of the commercial drug product manufacturing process
- Perform activities related to batch review & release
- Participate & provide input to root-cause analysis and CAPA plans
- Participate in process confirmations, change controls, & quality oversight
- Coordinate investigations at external sites related to OOS/OOT, deviations, and unexpected analytical results
- Perform trend analysis of testing and process data for commercial drug products and participate in continuous improvement projects
- Generate batch genealogy for commercial materials
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
- BA/BS degree in Life Sciences, Engineering, or related field required
- Minimum of eight (8) years of experience within the pharmaceutical industry required
- Solid understanding of CMC manufacturing and analytical activities required in commercial drug product manufacturing, including knowledge of cGMP regulations
- Good knowledge of the batch review processes required
- Experience with cGMP quality oversight and on floor production support required
- Understanding of Quality Management Systems required
- Prior experience as a liaison with solid oral dosage form contract manufacturing organizations required
- Significant analytical skills for integrating and interpreting interdisciplinary project information
- Excellent written and oral communication skills in English required; similar skills in German desirable
- Ability to periodically travel within the EU and to the United States
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 thishere
- 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
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