Amy Hartl
Director of Process Development @SHL Medical
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WORK HISTORY
Director of Process Development @SHL Medical
As the strategic leader of the Process Development (PD) department, I identify opportunities to expand the company\'s growth, while inspiring efficiency and effectiveness. Working directly with the Commercial team and C-levels, we define and implement immediate, short-term, and long-term strategies to optimize our offerings to best meet Customer and patient needs. Leading the PD team, including Manufacturing Sciences (MS), Analytical Sciences (AS), and Statistics, I provide direction, ensure alignment, and drive the team\'s commitment to execute projects on-time and with high quality. As the handshake between R&D and the commercial market, we strive to develop and execute quick to clinic and quick to market approaches for Customer products. Early planning, proactive management, and risk management are key for PD\'s project success. Project scopes include autoinjector final assembly and testing, device labeling, carton packaging/serialization, and bundling. Additionally, PD provides a variety of Technical Services (stability studies, CCIT, transportation studies, etc) to Customers. maintains the compliance of the site (temperature/light mapping, SAP maintenance, FDA inspection support, etc), and inspires a culture of continuous improvement through LEAN project execution.
EDUCATION
Ursinus College
Bachelor's Degree, Neuroscience
Florida Atlantic University
Master's Degree, Psychology
Florida Atlantic University
Doctor of Philosophy (Ph.D.), Experimental Psychology
SKILLS
ABOUT AMY HARTL
After earning my Ph.D. in Experimental Psychology at Florida Atlantic University, I…
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