Analytical Science & Technology Lead and Scientist

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 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 aims 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

Who You Are:

The Analytical Science & Technology Lead and Scientist will be responsible for overseeing the quality aspects of the analytical development activities in-house and at BridgeBio Gene Therapy’s Contract Development and Manufacturing Organization (CDMO). In addition, this individual will be responsible for the execution of assay development and testing activities relating to the biochemical and molecular attributes of rAAV-based gene therapy candidates to enable their cGMP production and release.  Both functions of this position will support multiple ongoing and incoming recombinant AAV-based gene therapy programs targeting rare genetic diseases.

The incumbent will partner with the analytical development scientists, process development scientists, Quality Lead, and the GMP functions. The ideal candidate should be home-based in the Raleigh, NC area with occasional travel (less than 25%) to the Baltimore-Gaithersburg-DC area.

Responsibilities:

• Lead and 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, and Manufacturing Science & Technology
• Develop, optimize, qualify and transfer phase-appropriate analytical assays to support non-clinical, CMC, and clinical development of gene therapy drug candidates
• Maintain documentation system within the Analytical Development department
• Assist in writing, reviewing, and editing standard operating procedures (SOPs) and work instructions (WKIs)
• Manages and optimizes strategies for efficient review, editing, and approval of documentation such STMs, WKIs, validation plans/reports, SOPs
• Review CDMO analytical test results and conduct data trending analyses
• Review and approve in-house assay development and characterization study reports
• Draft assay qualification protocols and review/approve qualification and validation reports
• Leads the troubleshooting effort in support of cGMP QC investigations for OOS or other deviations
• Assist in drafting regulatory submission documents
• Participate in quality audits at CDMO and GMP facilities
• Organizes communication plans and forums

Education, Experience & Skills Requirements:

• 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
• 1+ years of CDMO tech transfer experience and a strong laboratory skillset are required
• Gene therapy experience is preferred
• Experience with quality audits at CDMO and GMP facilities is preferred
• Strong track record of effectively communicating with cross-functional teams and CDMOs
• The ideal candidate will have relevant knowledge in analytical development for the characterization and QC release of AAV gene therapy vectors or other relevant biologics; Familiarization with ICH and FDA guidelines is expected
• Experience in qualifying and validating test methods in support of clinical or commercial manufacture is preferred
• The incumbent is expected to be proficient in sample preparation, data analysis, and operating/troubleshooting bioassay and cell-based assays using some of the following techniques: ELISA, qPCR, digital droplet PCR, Western blotting, mammalian cell culture/transfection, small animals/tissue sample handling, and FACS
• The incumbent should be a detail-oriented self-starter and be able to work independently under limited supervision and effectively communicate results/conclusions to peers and management
• Direct experience within the biopharmaceutical industry performing Quality Assurance/QC work with a strong familiarity with 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

We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.