Drexel University - School of Biomedical Engineering
Managed IS portfolio for and partnership with Global Clinical Supplies operation through alignment of business & IT strategies.Oversaw up to 25 internal and contracted staff with annual budget of $7.5MM.
Directed staff, processes, data quality, and P&L for IT operations, including data center and company-wide infrastructure.Provided IS support to Sales and Marketing. Established, executed, and monitored quality/regulatory strategies for this software manufacturer serving pharmaceutical industry.
Led team of 10 in full SDLC development, technical support, operations, and QA. Collaborated to create corporate strategy, gap analysis, and resultant product roadmap. Provided on-site sales and installation support.Evaluated compliance with GLP and 21CFR11 guidelines; hosted multiple GLP auditors and communicated with FDA representatives as needed.
Designed and developed software solutions to meet Wyeth’s business requirements. Supported scientists and laboratory hardware and software systems associated with Discovery Research.
Created and implemented hardware/software solutions to automate bench chemistry and packaging for start-up medical device company that prevented rate-limiting assembly line processes.Provided IT desktop support and authored GMP SOPs.
Carried video switching products through design, manufacturing, QA, and FCC emission compliance.Designed circuit boards with CAD & programmed in Motorola assembly language.