Nathan Lee
About
Nathan Lee is from Raleigh, North Carolina, United States. Nathan is currently Senior Director, Head of Technical Product Leadership at Avidity Biosciences, Inc.. In Nathan's previous role as a Senior Director, Head of CMC at Poseida Therapeutics, Inc., Nathan worked in until Aug 2025. Prior to joining Poseida Therapeutics, Inc., Nathan was a Director, Head of Manufacturing Sciences & Technology at Beam Therapeutics and held the position of Director, Head of Manufacturing Sciences & Technology at Raleigh, North Carolina, United States. Prior to that, Nathan was a Director, Head of MS&T and CMC Strategy, Gene Therapy at PTC Therapeutics, Inc. from Sep 2019 to Feb 2021. Nathan started working as Associate Director, Technical Product Team Lead (CMC Lead) at Bristol-Myers Squibb in Devens, MA in Oct 2017. From Mar 2016 to Oct 2017, Nathan was Manager, Manufacturing Technology, MS&T at Bristol-Myers Squibb, based in Devens, MA. Prior to that, Nathan was a Technology Transfer Manager, MS&T at Bristol-Myers Squibb, based in Devens, MA from Feb 2014 to Mar 2016. Nathan started working as Sr. Process Engineer at Pall Life Sciences in Greater Boston Area in Jan 2013.
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Nathan Lee's current jobs
Nathan Lee's past jobs
• Established and implemented Gene Therapy CMC capabilities and development strategy. • Led process & analytical development and manufacturing for multiple modalities to enable nonviral and hybrid (nonviral+viral) therapeutic platforms. • Established outsourcing partnerships (CDMOs/CTLs) for development, manufacturing, testing and logistics. • Led CDMO selection and RFP process, assessment of technical capabilities, budget oversight and management. • Managed budget of >$24MM across two programs, leading contract negotiations and approvals.
• Built the MS&T organization comprised of CMC subject matter experts in cell therapy, mRNA, and lipid nanoparticle technologies. • Led Process Readiness team at a site start up, including equipment selection, facility fit, technology transfer and manufacturing implementation for ex vivo gene edited cellular therapeutics, mRNA, and LNP modalities. • Represented internal manufacturing site and MS&T on program product strategy teams and provided phase appropriate guidance to CMC teams.
• Established and led high-performing MS&T and CMC Strategy teams. • Managed outsourced gene therapy programs with CDMOs, leading four early and late stage AAV programs . • Authored MAA submission for Upstaza™, led triaging of review feedback.
• Led two commercial CMC teams for Nulojix® and Empliciti™ accountable for technical, operational, quality, and regulatory strategy implementation. • Established strategies for technology transfers, manufacturing, regulatory submissions, and process lifecycle management. • Interfaced with senior management stakeholders to provide program updates and aligned brand technical strategy with supply chain and clinical strategies.
• Managed a team of engineers accountable for technology transfer, process validation, and manufacturing technical support. • Led technology transfers, process troubleshooting, and process improvements for large-scale biologics processes.
• Managed a team accountable for technology transfer of biologics processes, overseeing upstream, downstream, and cryogenics processes. • Developed robust technology transfer and process validation strategies for regulatory filings. • Led scale-up to commercial production, process validation activities, and process redesign studies.
• Served as a Subject Matter Expert for recovery and downstream process technologies, including chromatography and filtration. • Led development and optimization studies, correlating process performance with client data for robust recommendations. • Provided technical troubleshooting and scale-up expertise, mentoring new team members and junior engineers.
• Led development and characterization of recovery and downstream unit operations for Phase I/II/III/commercial programs. • Performed process scale-up and technology transfer to pilot and production facilities, ensuring facility fit and gap analysis.
• Designed and executed process development and characterization studies for various unit operations.