Associate Scientist
CurrentLiquid Drug Product Development: Extensive experience in formulation and commercial process development for liquid drug products, ensuring high-quality outcomes and regulatory compliance. Vapor Phase Hydrogen Peroxide (VPHP) Expertise: Subject matter expert in VPHP decontamination processes for drug product formulations at commercial scale. Unit Operations and Scale-Up: Proficient in unit operations, including scale-down modeling, development, characterization, and scale-up for formulation, mixing, filtration, and aseptic filling processes. Protein Stability and Product Quality: Deep understanding of protein physical and chemical stability, with expertise in evaluating the impact of processing stresses on product quality. Late-Stage Product Development: Skilled in process characterization, equipment design and implementation, and technical transfers to global manufacturing sites. Proficient in statistical process control (SPC) and the statistical design and analysis of experiments (DOE). Regulatory Documentation: Authored Clinical Trial Applications (CTA) and Marketing Applications (MA), collaborating closely with Quality Control and Regulatory Agencies to ensure compliance with regulatory standards. Lab Safety Leadership: Served as Lab Safety Captain, overseeing monthly lab walkthroughs with Environmental Health teams to maintain a safe working environment. Conducted new hire lab safety orientations and acted as the primary contact for safety-related questions and concerns. Designed and implemented engineering and administrative controls in response to safety incidents, promoting a culture of safety.