Director – Analytical Method Development
Posted on 9/24/2023
Raleigh, NC, USA
Experience Level
Desired Skills
Data Analysis
Biology & Biotech
  • 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
  • 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