About BridgeBio Gene Therapy & BridgeBio Pharma
BridgeBio Gene Therapy, a subsidiary of BridgeBio Pharma, is focused on discovering and developing drugs for patients with grievous genetic diseases. We do this by:
Finding the right starting points to target diseases at their source.
Using a combination of a systematic assessment of the genetic disease landscape and informed diligence on the latest research, we find indications with clear mechanisms of pathogenesis that are ripe for translation into disease-modifying drugs.
Building products with world-class R&D personnel.
We employ industry-leading scientists that work closely with leading academics to prosecute a wide variety of drug programs at the highest level of scientific rigor. Our team combines biopharmaceutical veterans with up-and-coming leaders to drive entrepreneurial thinking grounded by experience.
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.
Who You Are
The Director of Analytical Method Development is a senior member of the Technical Development and Operations (TDO) group at BridgeBio Gene Therapy (BBGT). The position is responsible for managing the lifecycle of our analytical methods and the operations of the Analytical Method Development (AMD) team. In addition to leading the development of release and characterization assays for our pipeline of recombinant AAV (rAAV)-based gene therapies, the role includes oversight of external method qualifications and validations and support of QC testing of clinical trial material. This individual will work closely with TDO colleagues in Process Development and Manufacturing Sciences and Technology and cross-functionally with the BBGT R&D group and our external partners.
The position is based in our Raleigh, NC facility.
Responsibilities
- Lead a team of scientists across analytical disciplines, including cell-based, biophysical, and molecular biology
- Establish and execute strategies for assay development, optimization, transfer, qualification, validation, and maintenance
- Accountable for the accuracy of technical reports, protocols, and regulatory filings
- Advance product and process understanding through developing and implementing fit-for-purpose analytics
- Drive assay optimization via new technologies and high-throughput automation
- Represent AMD during cross-functional discussions to develop phase-appropriate strategies for new and existing programs
- Through Analytical Sciences and Technology, support the transfer and phase-appropriate validation of assays to CRO and CDMO partners and, when needed, provide guidance to support their successful execution
- Collaborate with internal functions, including R&D, Quality, Clinical, and Regulatory
- Collaborate closely with external partners to ensure method validations are aligned with current ICH and regulatory guidelines
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
- Degree in Biochemistry, Chemistry, Molecular Biology, or related field with at least 5 (Ph.D.), 10 (M.S.), or 15 years (B.S.) of experience directly applicable to the job responsibilities
- Biotech experience, including the transition of early-stage QC methods to late-stage programs, including preparation of regulatory filings
- rAAV-based gene therapy experience is required
- Experience leading a large team composed of scientists at varying levels is required
- Deep understanding of cell-based potency assays designed to measure the mechanism of action of both rAAV vectors and recombinant proteins synthesized in transduced cells
- A demonstrated track record of successfully transferring, qualifying, and validating analytical methods. Familiarity with GMP, ICH, and associated regulatory guidelines
- In-depth knowledge and extensive hands-on experience with analytical chemistry and molecular biology methods, including SEC, CE, UPLC/HPLC, Mass Spectrometry, ELISA, Western blot, ddPCR, RT-PCR, SPR/BLI, and flow cytometry/FACS
- Competency with data analysis and statistics software, e.g., SoftMax Pro, JMP, PLA 3.0
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
- Partnerships with leading institutions
- Commitment to Diversity, Equity & Inclusion
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
