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Thierry-Thien Nguyen

Student at University of the Sciences
Objective: Combine knowledge and skill sets in Biotechnology, Technology Management and Lean to bring business and operational aspects to into research and process development, to enable efficient road to successful commercialization and product launch. Areas of Expertise: Cross organizations and cultures project management experience; Early, Mid and Late Phase drug product formulation development; Fil-Finish Process Development; GLP and GMP Fill-Finish Tech Transfer; Process Validation/Process Performance Qualification and Strategy; Tech Transfer Project Management, Technology Management. Biologics/Therapeutics Protein Process Development and Commercialization, Biologics License Application (BLA) writing; Upstream process development, primary recovery and downstream process at lab scale and pilot scale, Molecular Cloning and Recombinant Protein Technologies, R&D experience in Stem Cells, Cancer Stem Cells, Cancer, 3D Organotypic Reconstruction, Targeted Therapeutics and Validation, Signaling, Animal Protocol, Preclinial Trials
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Sr. Associate Scientist at Janssen, Pharmaceutical Companies of Johnson and Johnson
Pharmaceutical Development & Manufacturing Sciences - Drug Product Development Lead early, mid and late stage drug product formulation and process development; develop fill-finish process for biologics and adjuvanted protein vaccines; identify and manage project risk and mitigation plan using tools such as FMEA, CMAs, CQAs, CPPs to enable successful tech transfer to manufacturing facilities. Lead and design experiments at lab scale (including downscale and upscale) to trouble shoot technical issues, gap experiments required for process development, enable process performance qualification and BLA filing Lead and manage early and late stage drug product formulation development and process development via working with CRO/CMO network. Work with both internal and external supply chain network to successfully resolve capacity and technical challenges. Lead pre-NME projects, design and conduct HTS in a DOE style to support developabality evaluation; providing data-driven summary from both HTS and in-vial stability to enable NME-decision making for mAb and other biologic molecules. Lead department Lean implementation by using Lean tools with an end-user driven approach. Design and implement lab layout, to support Lean effort, successfully move and re-implement LEAN to new site and transform LEAN practice to new level of success at new site. Support the initiatives PDMS Lean in Early Development strategy and PDMS DPD Polysorbate Control strategy Lead, establish and shape outsourcing practice to CRO/CMO. Manage and track outsourcing portfolio, create a forum of interactions across functions (API, DPD, Procurement, AD) and between Janssen and CRO/CMO. Serve as subject matter expert for adjuvnated protein vaccine formulation and process development; adjuvanted protein fill-finish process; end-user center approach drug product development, complex pharmacy mixing design, Filter Validation, filling/stoppering operation, bench top fill/finish automation assessment.
April 2013 - Present
Associate Scientist at Janssen, Pharmaceutical Companies of Johnson and Johnson
Pharmaceutical Development & Manufacturing Sciences - Drug Product Development
February 2012 - Present
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