BridgeBio 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 finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aim to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country.
To learn more, visit us at https://bridgebio.com
Remote / Raleigh, NC / Baltimore-Gaithersburg-DC Area
Who You Are:
The Analytical Science & Technology Lead is responsible for overseeing the quality aspects of the analytical development activities both in-house and at BridgeBio Gene Therapy’s Contract Development and Manufacturing Organization (CDMO) to support multiple ongoing and incoming recombinant AAV-based gene therapy programs targeting rare genetic diseases.
The incumbent will work in partner with analytical development scientists, process development scientists, Quality Lead, and the GMP functions. This is a remote position with occasional travel (less than 25%) to Raleigh, NC area. Ideal candidates should be home-based in the Baltimore-Gaithersburg-DC area.
- Manage Analytical Development equipment, including but not limited to installation, calibration, and preventive maintenance, to ensure quality compliance
- Maintain documentation system within the Analytical Development department
- Manages and optimizes strategies for efficient review, editing and approval of documentation, STMs, validation plans/reports, SOPS
- Review analytical test data and reports from CDMO
- Review and approve in-house assay development and characterization study reports
- Assist in writing, reviewing, and editing of standard operating procedures (SOP) and work instructions (WI)
- Draft assay qualification protocols and review/approve qualification reports
- Draft tech transfer protocol, oversee the transfer activities from in-house to CDMO, and assist in the implementation of the assays at the CDMO
- Effectively communicate with cross-functional team members such as Process Development, Quality Assurance, Quality Control
- Leads the troubleshooting effort in support of cGMP QC investigations for OOS or other deviations.
- Assist in drafting regulatory submission documents
- Participate quality audits at CDMO and GMP facilities
- Organizes communication plans and forums.
- B.S. in Biology, Chemistry, Life Sciences or related field and >6 years of industry experience
- M.S. in Biology, Chemistry, Life Sciences or related field and 3-5 years of industry experience
- Laboratory experience in cell-based assays and biophysical assays (enzymatic reaction measurement, HPLC, PCR, qPCR, ELISA, spectrophotometric assays, etc.) will be a strong plus
- Direct experience within the biopharmaceutical industry performing Quality Assurance/QC work with a strong familiarity of general GMP practices
- Knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks
What We Offer:
- Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
- Learning and development training to help employees be the best version of themselves
- Collaborative business environment
- Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
- Excellent benefits package
- Flexible PTO
- With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
- A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
- Work with the most productive groups of R&D operators in the industry
- Partnerships with leading institutions
- A platform for meaningful scientific contributions to shine
- Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so