• 8+ years working in a fast-paced GMP environments and delivering high quality milestones on schedule.
• Experienced in tech transfer, process development, and scale-up activities for commercial-scale biologics manufacturing.
• Evaluating empirical data to identify areas for improving process efficiencies and yields.
• Proficient in the operation, development, and validation of an variety of analytical techniques, including HPLC, GC, TOC, and LC-MS.
• Maintaining diligent GDP documentation in both hardcopy and electronic laboratory notebooks.
Publication date: Jan 2015
This article is based on a presentation given at the ISPE 2013 Annual Meeting and presents an overview of a novel quantitative method utilizing imaging software combined with tightly controlled variables in lighting, angle, and distance, quantifies the amount of process residue on a surface using high-resolution photographs, to produce statistically significant data.
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