Director, Analytical Development
Apply NowCompany: BridgeBio Pharma, Inc.
Location: San Francisco, CA 94112
Description:
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 looking to fill a position within Analytical Development for a Director in the Chemistry and Manufacturing and Controls (CMC) team. This position will report to the Senior Director of Analytical Operations and will work closely with the entire CMC team to execute late-stage development activities in support of Phase III clinical trials as well as NDA readiness activities. Candidates for this position will be required to work independently, have experience overseeing outsourced analytical activities at contract manufacturing sites and testing labs and supervise the operations of a direct report.
Responsibilities
No matter your role at BridgeBio, successful team members are:
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.
Salary
$210,000-$255,000 USD
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 looking to fill a position within Analytical Development for a Director in the Chemistry and Manufacturing and Controls (CMC) team. This position will report to the Senior Director of Analytical Operations and will work closely with the entire CMC team to execute late-stage development activities in support of Phase III clinical trials as well as NDA readiness activities. Candidates for this position will be required to work independently, have experience overseeing outsourced analytical activities at contract manufacturing sites and testing labs and supervise the operations of a direct report.
Responsibilities
- Oversee the development of analytical methods, method validation, and investigations for out-of-specification, out-of-trend, and/or aberrant results by vendors
- Provide technical review of various reports and raw data packages utilizing a strong familiarity of small molecule analytical techniques
- Review and critically assess data from ongoing GMP stability studies
- Contribute to the development and approval of specifications for raw materials, intermediates, drug substance, and finished products with knowledge of regulatory requirements in setting acceptance criteria
- Oversee the maintenance of a reference standard and qualitative markers portfolio
- Manage analytical method transfers to drug substance and product manufacturing sites
- Author and review quality documents such as deviations, change controls, and SOPs
- Author, review, and adjudicate Analytical Development reports, protocols, methods, and filing documents such as NDA modules and agency inquiries
- Able to communicate results both internally and externally through oral and written updates and formal reports as necessary
- Supervise the activities of a direct report
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
- At least 10 years of experience in Analytical Development in a pharmaceutical setting
- Independently proficient in various analytical techniques such as dissolution, GC, GC/MS, HPLC, KF, LC/MS, NMR, pH, UV/Vis, and XRPD
- Experience with chromatography data acquisition systems and electronic document and quality control systems
- Familiarity with CMC analytical regulatory requirements and authoring of IND/IMPD/NDA/MAA filings and responses to regulatory inquiries
- Experience applying regulatory guidelines (ICH, FDA, EMA, etc.) to pharmaceutical development and CMC strategy
- Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates. Ability to understand project timelines and appropriately prioritize activities to achieve project goals
- The position will require an ability to adapt to changes in priorities on short notice and will also require an ability to make decisions, independently, under tight timelines
- The position requires 5-15% travel. Must have the ability to travel internationally
- 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
- Partnerships with leading institutions
- 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.
Salary
$210,000-$255,000 USD