Brian Nasielski
Research & Development @ Regeneron Pharmaceuticals
- Role
- Process Development Associate Ii (Analytics) at Regeneron
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Brian Nasielski
R&D associate within Regeneron’s Product, Analytics, and Process Development (PAPD) group, with a focus on analytical biochemistry, process development and CMC tech transfer for late-stage/commercially-enabling antibody programs. Part-time graduate student at Johns Hopkins University studying Biotechnology, with a concentration in business.
Experience
Process Development Associate Ii (Analytics)
Jul 2023 — Present · Tarrytown, NY, US
Serve as the primary analytical developer for the commercialization of 3 late-stage therapeutic antibodies; responsible for assay development to measure 10+ critical quality attributes, generating and presenting data across the R&D organization, and supporting international tech transfer activities to enable scale-up and regulatory filing.• Utilize JMP to statistically characterize (ANOVA, REML) internal assays and comprehensively document platform validation parameters, thus eliminating 20 redundant studies per year and reinforcing ICH regulatory guidelines.• Supported testing and launch of a new enterprise data management system, Benchling, supporting 200+ scientists and engineers; designated group subject matter expert, establishing measurable success criteria and training 20+ staff on key features: control charting/data visualization, sample mapping, ELN creation.• Participated in a 1-year R&D mentorship program shadowing Clinical Trial Management, Precision Medicine, Regulatory Affairs, and Trial Feasibility, gaining exposure to oncology trial endpoints, drafting protocol amendments, and clinical portfolio advancement.
Education
Lenape High School
High School Diploma
2015 — 2019
Lehigh University
B.S. Chemical Engineering, B.S. Biochemistry
2019 — 2023
The Johns Hopkins University
Master of Science - MS, Biotechnology (Enterprise and Entrepreneurship)
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