President

Managed and coached a technical team responsible for Combination Products analytical testing. Implemented analytical capabilities to meet FDA CFR Parts 210/211 compliance for combination products testing, such as elution testing of drug-device sub-assemblies, antimicrobial drug/device pre-formulation studies, etc. Oversaw analytical activities for commercial release testing, site qualification studies, materials testing, residuals, and extractables and leachables testing per ISO-10993 compliance. Served on corporate team for Leachables & Extractables Initiatives. Provided internal expert consultation services for ICH Stability Studies, and Shelf-Life Evaluations.

Analytical Research and Development Chemist for Drug Substance Development, Topical Gels, Creams, Solutions, and Metered-Dose Inhalers for Inhalation Technology. Worked in several global multidisciplinary functions in Research and Development, Pre-formulation studies, FDA Chemistry, Manufacturing, and Controls (CMC), Drug Substance Process Scale-up and Manufacturing. Led CMC subteam for drug substance development for a partner-funded program. Utilized advance analytical techniques for method development and validation, method crossover, stability testing, forced degradation studies, API solid-state characterizations including crystal form polymorph screening. Completed six sigma green belt training.