Rae Sung Chang Email and Phone Number
Rae Sung Chang work email
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Rae Sung Chang personal email
Highly motivated, independent and detail-oriented Ph.D. biologics formulation/process development scientist• Lead formulation development for monoclonal/bispecific antibodies and siRNA conjugates• Lead formulation/downstream process/drug product development of gene therapy products (AAV) • Review/author regulatory CMC documents and technical source documents• Liaising cross-functional CMC teams with great communication skills• Skilled at analytical characterization of biologics (U/HPLC, fluorescence, DSF, SDS-PAGE, CD, ELISA, DLS, DSC, ITC, BLI) and screening of stabilizing factors & excipients (sugars, surfactants, buffer salts, pH, concentration)• More than 7-year experience in formulation and characterization of injectable PLGA-based depots (implants, microspheres) for controlled/sustained release of biologics (peptides, proteins, anti-VEGF monoclonal antibodies for ocular delivery, immune checkpoint antibodies provided from Bristol-Myers Squibb)• Extensively experienced in parenteral drug delivery: formulation of a wide range of drug modalities (small molecules, nucleic acids, peptides, proteins, viral vectors) in various delivery systems (injectables, liposomes, polymers, micro/nanoparticles, polymeric implants)• Comprehensive experience in developing siRNA delivery systems from in vitro characterization, cellular/molecular biological assays to in vivo evaluation in mouse model • Experienced in developing lateral flow immunoassays for rapid diagnostic test of infectious diseases and technical documentation such as regulatory submission to FDA, design control, SOPs, and process development/validation• Research achievements/expertises demonstrated by 8 publications in scientific journals and book chapters, 6 patents of pharmaceutical inventions, 20 presentations at national and international conferences, and 40 scientific journal review assignments (Journal of Controlled Release, Nanomedicine:NBM, European Journal of Pharmaceutics and Biopharmaceutics, Drug Delivery and Translational Research)
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Principal ScientistRegeneron Oct 2023 - PresentTarrytown, New York, Us• Lead and participate in drug product development and stability assessment activities that include candidate screening and selection for preclinical and Phase 1 clinical studies, and develop formulations for Phase 2/3 clinical studies and commercialization including assessment and selection of primary container closure system such as pre-filled syringes• Develop drug product formulation for a diverse set of modalities such as mAbs, mAb-like proteins, Bispecfic antibodies, and siRNA• Directly lead or indirectly guide Research Associates in conducting research and developmental work and investigate/solve developmental problems. Set goals, assign tasks, and provide performance management and development as needed• Independently design, write, execute and document stability studies and other experiments to support stability testing and understand quality attributes to support formulation and drug product development• Develop and use analytical methods to support formulation development and stability testing of mAbs, Bispecific, siRNA, and other modalities• Seek out, recognize and assess new technologies to improve formulation development and analytical characterization• Present work at group, department and inter-department meetings, serve as a team representative in drug development team meetings, and share knowledge and expertise of formulation development at cross-functional team meetings• Author and review formulation development sections of regulatory and technical documents, study reports and technology transfer documents• Collect, process and document data by following the organizational standard methodologies and policies• Utilize statistical knowledge and software packages (e.g. JMP) for study design and data analysis• Keep updated on the latest scientific findings by reading peer-reviewed science journals, and attending and presenting at relevant scientific conferences
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Senior Scientist, Downstream Process Development - Gene TherapyPtc Therapeutics, Inc. Apr 2022 - Oct 2023Us• Formulation Development Lead for Gene Therapy (AAV) Drug Substance/Drug Product o DS/DP (AAV) formulation screening by biophysical characterization using automated high-throughput instruments (Big Tuna, Uncle, Stunner) and DoE as an SME o Leading developmental stability studies o Designing/executing formulation robustness studies for regulatory filing o Liaising in-house/external analytical testing o Evaluating excipients for stability, efficacy, safety, and manufacturability o Supporting device compatibility/pharmacy manual studies and vial fill/finish processes o Executed syringe evaluation studies for dose preparation o Authored formulation development reports• Downstream Process Development Lead for Gene Therapy Programs o DS/DP process technology transfer to GMP manufacturing o Leading timeline/plan for downstream process development as a functional lead for GLP Tox/FIH studies o Managing/scaling up downstream process unit operations including TFF, affinity/IEX chromatography, sterile filtration, freeze/thaw, mixing/pooling, formulation, dilution steps o Developing continuous-flow ultracentrifugation for improved AAV full capsid enrichment o Reviewing regulatory CMC documents (IND/CTA Module 3, Briefing Book) o Authoring/reviewing technical documents including development reports, process descriptions, facility fit reports, SOP, technical memos, FMEA, risk assessment o Managing direct reports -
Scientist Ii, Downstream Process Development - Gene TherapyPtc Therapeutics, Inc. Nov 2020 - Apr 2022Us
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Associate Principal ScientistAccess Bio, Inc Jan 2019 - Nov 2020Boyce, Virginia, Us• Developed COVID-19 antibody/antigen rapid diagnostic test kits• Collaborated with Bill & Melinda Gates Foundation for development of highly sensitive malaria rapid diagnostic test kits -
Postdoctoral Research FellowUniversity Of Michigan Nov 2016 - Dec 2018Ann Arbor, Michigan, Us• In vivo anti-VEGF efficacy test of injectable PLGA/bevacizumab implants in rabbit retinal vascular leakage models – Working with a contract research organization (CRO) • Optimization of injectable polymeric implants using various polymers and coating methods• Evaluation of injectable PLGA implants for sustained release of immune checkpoint antibodies provided from Bristol-Myers Squibb• Nanoparticle (gold nanoparticle, silica, synthetic HDL, dendrimer)/protein conjugation for ocular delivery -
Ph.D. StudentUniversity Of Michigan - Rackham Graduate School Sep 2010 - Sep 2016Ann Arbor, Mi, Us• Formulation and characterization of PLGA depots (self-encapsulating microspheres, coated implants) to sustain release of anti-VEGF monoclonal antibodies for ocular delivery• Characterization of protein stability in various aspects (size-exclusion HPLC, CD, ELISA)• Analysis of microstructures of PLGA microspheres and implants (SEM, confocal microscopy) • Solubilization of poorly soluble peptide using various excipients -
Research AssistantSeoul National University Sep 2009 - Jun 2010서울시, Seoul, Kr• Comprehensive experience in evaluating siRNA delivery systems from in vitro (cellular uptake test, knock-down test in mRNA and protein level) to in vivo (anti-cancer efficacy in mouse model) tests• Formulation and characterization of cationic drug-derived lipid nanoparticles for anti-cancer siRNA delivery• In vivo (near IR) optical imaging of distributed nanoparticles in mouse model -
M.S. StudentKorea University Mar 2007 - Feb 2009Seoul, Kr• Screening siRNA targets for anti-cancer efficacy• Formulation of anionic liposomes to reduce toxicity of cationic anti-cancer drugs• Development of a novel conjugation method of antibodies for immunoliposomes -
B.S. StudentKorea University Mar 2006 - Feb 2007Seoul, Kr• Solubilization of hydrophobic anti-cancer drugs using liposomes
Rae Sung Chang Skills
Rae Sung Chang Education Details
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University Of Michigan - Rackham Graduate SchoolPharmaceutical Sciences -
Korea UniversityBiomedical Sciences And Engineering
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Korea UniversityLife Sciences
Frequently Asked Questions about Rae Sung Chang
What company does Rae Sung Chang work for?
Rae Sung Chang works for Regeneron
What is Rae Sung Chang's role at the current company?
Rae Sung Chang's current role is Principal Scientist, Formulation Development Group at Regeneron.
What is Rae Sung Chang's email address?
Rae Sung Chang's email address is rc****@****bio.com
What schools did Rae Sung Chang attend?
Rae Sung Chang attended University Of Michigan - Rackham Graduate School, Korea University, Korea University.
What skills is Rae Sung Chang known for?
Rae Sung Chang has skills like Molecular Biology, Leadership, Microsoft Office, Drug Delivery, Microsoft Word, Protein Characterization, Research, Microsoft Excel, Science, Higher Education, Cell Culture, Targeted Drug Delivery.
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