Michael Le Email & Phone Number

Boston, Ma, Us

Andover, Massachusetts, United States

Downstream | Protein Purification

Lexington, Ma

• Designed, planned, and executed late-stage downstream purification and process characterization studies, including DoE studies, to define and optimize process parameters, operating ranges, and control strategies.• Coordinated with MSAT, upstream, analytical development, and supply chain departments to provide downstream SME support for manufacturing deviation investigations, process troubleshooting, CAPAs, and change controls.• Supported optimization and scale-up of chromatography (affinity, ion exchange, etc.) and filtration processes (UF/DF, depth filtration, sterile filtration, etc.) for AAV purification.• Supported qualification of scale down models for process characterization and viral clearance studies.• Provided mentorship to 3 engineering co-ops and guided development of their downstream and technical laboratory skills.• Reviewed experimental data, authored technical reports, and regularly presented project updates to cross-functional teams of engineers and scientists.• Researched published literature for innovative downstream process technologies to improve uniQure’s AAV process and manufacturing platform.• Implemented 5S methodology to improve lab efficiency, safety, and organization.

Cambridge, Massachusetts, United States

• Developed environmental, health and safety (EHS) programs, in compliance with local and state regulations, for 6 life science companies in the Greater Boston Area.• Implemented hazard communication programs to support GMP production of cellular therapies that use viral vectors, including AAV and LVV.• Conducted risk assessments and job safety analyses, identified potential hazards within manufacturing and laboratory processes, and recommended improvements to standard operating procedures (SOPs).• Coordinated, prepared, and presented biweekly biosafety and chemical safety trainings to new hires.

Charleston, South Carolina, United States

• Researched a diagnostic technique for degenerative joint diseases that utilizes nonlinear optical microscopy and fluorescence excitation to analyze intrinsic cellular signals and assess tissue health.• Designed, modeled, and 3D-printed microscopy devices for aseptic imaging of live cell and tissue cultures.• Assisted AI-driven projects designed to analyze medical imaging data and automatically identify healthy and diseased cells within live tissues.• Mentored 4 undergraduate research students with projects in microscopy and cell culture.

Omaha, Nebraska, United States

• Developed automated ICP-MS sample dilution and autosampler systems, customized for client-specific trace metal analysis applications.• Troubleshot automation systems for clients through remote and onsite support. Experienced with Thermo Scientific, Agilent, and Perkin Elmer instruments.• Optimized ICP-MS trace metal analysis protocols for biological samples by extending sample analysis windows while reducing minimum sample volume requirements by 50%.

Lincoln, Nebraska, United States

• Taught students how to interpret NMR, FTIR, and GC-MS results.• Prepared classroom laboratory chemicals and instruments.

Elkhorn, Nebraska

• Applied spectroscopic and thermoanalytical techniques to determine optimal lyophilized vaccine formulations that yield minimal protein aggregation and improved long-term stability.• Performed Western blots, SDS-PAGE, DLS, UV-vis, and HPLC to characterize proteins.• Supported the development of an animal vaccine against bovine respiratory syncytial virus.

Lincoln, Nebraska

• Prepared medication with attention to specific dosages and sterile methods.• Assisted pharmacists and doctors with patient medication orders.

Lincoln, Nebraska

• Assisted with Phase I clinical research and documentation for drug development.• Monitored EKG and vital signs of study participants, and assisted phlebotomists.

Lincoln, Nebraska

• Mentored students in math and science.• Motivated students to pursue interests in future STEM careers.

Master Of Science - Ms, Bioengineering

Thesis: Nonlinear Optical Microscopy Assessment of Tissue Structure and Chondrocyte Viability of Articular Cartilage

Bachelor Of Science - Bs, Chemical Engineering