Job: Scientist of Biophysical Chemistry-Analytical Development, BridgeBio Gene Therapy Inc., Raleigh, NC
The Scientist of Biophysical Chemistry is an important member of the CMC Analytical team and is responsible for executing assay development and testing activities relating to the biophysical attributes of rAAV-based gene therapy candidates to enable their cGMP production and release. This individual will work in partnership with Non-Clinical Development, Upstream/Downstream Process/Formulation Development functions to deliver products for clinical testing and serve as a technical expert on analytical assays in communications with internal stake holders and external partners.
• Develop, optimize, qualify and transfer phase-appropriate analytical assays to support non-clinical, CMC, and clinical development of gene therapy drug candidates
• Contribute to the designing and execution of experiments for qualitative and quantitative characterization of recombinant AAV-based gene therapy candidates
• Supports process optimization during CMC development by generating timely analytical test results regarding the quality attributes of the in-process materials
• Troubleshoot process development issues, out-of-specification, and other deviations through detailed analysis using biochemical/biophysical, molecular and other analytical techniques.
• Execute forced degradation and stability program
• Perform routine sample testing activities and ensure timely turnaround
• Author study protocols, characterization reports, and development reports
• Present results to colleagues, management, and external partners when necessary
• Ensure all experimental procedures and documentation are compliant with highest quality and regulatory standards
• Calibrate and maintain laboratory equipment
• Develop work plans and prioritize work according to program needs to make sure timelines are met
• Master’s degree with 2+ years post-graduate experience in virology, molecular biology, biochemistry, or analytical chemistry. Strong laboratory skill is a must.
• The ideal candidate will have relevant knowledge in the field of analytical development for 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 will be a strong plus
• The incumbent is expected to be proficient in sample preparation, analysis, and data interpretation using some of the following techniques: HPLC/UPLC (reversed phase, size exclusion, normal phase, ion exchange), capillary electrophoresis, gel electrophoresis, UV/Vis, analytical ultra-centrifugation, mass spectrometry, particle size analysis
• 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.
• The qualified candidate must be a team player that can effectively partner with diverse team members from various functions
• Level will be commensurate with experience