Emeryville, California, United States
A biotechnology professional, with over 14 years of experience specializing in manufacturing operations, process validation, and change management. Versatile, flexible and dedicated, with a proven record of working across disciplines, from on-the-floor to CMC groups, to deliver successful outcomes. Strong technical and quality-driven mindset for ensuring compliant drug substance and robust processes. I am passionate about helping people live fuller lives through the biotechnology industry. I am interested in opportunities around validation, quality assurance, operations, technical transfer, and other technical roles.
Operations specialist responsible for the direct production, technical transfer, and process implementation of multiple GMP clinical-scale monoclonal antibody therapies.
Process Validation lead for Phase 2/3 commercial gene and enzyme replacement therapy products. Collaborated extensively with multiple stakeholder groups across the organization to execute validation activities, including lifetime use studies, drug substance process simulations, and process improvements, in support of realizing company goals.
Upstream technical specialist for GMP commercial-scale bacterial fermentation-based enzyme replacement therapies. Worked in Process Team model of assigned SMEs to dynamically and cohesively respond to operational challenges, manage resources, and achieve department goals, all within a lean environment. Served as primary change control author and owner, deviation investigator (earned internal Six Sigma White belt status), and primary Manufacturing process contact for all operational support activities, with the ultimate goal of improving operational stability with continuous improvement activities.
Upstream technical process expert for multiple GMP commercial-scale perfusion-based enzyme replacement therapies. Liaison and technical resource for all groups within and without Technical Operations in support of ongoing operations in a lean environment. Served as primary Manufacturing change control author and owner, primary Manufacturing technical contact for all support activities, including troubleshooting issues, BOM updates, training efforts, equipment ownership, and others, primary area author for all process documents and training materials, and mentor to floor staff for movement into specialist roles.
Maintained lab operations - made buffers, media, dilutions, cleaned glassware, autoclaved waste. Assisted in research projects - lab focus on epilepsy treatment modalities and traumatic brain injury studies. Constructed research apparati - Faraday cages, behavioral study setups, etc. Performed small-scale molecular biology techniques - maxi/minipreps, gel electrophoresis, etc.
Studied flagellate structures of Giardia, performed molecular biology techniques, maintained lab operations.