Description
SUMMARY * Scientific Leadership-Pharmaceutics. Wealth of experience (>25 years) in delivering impactful products to the market through Formulation/Process development (solids, liquids, and parenteral dosage forms) and Analytical development. Key example: Lexapro marketed by Forest. * Organizational Leadership and Mentor. Scientific organization management that focused on learning and delivering results. Underlying philosophy was to develop scientist leaders who operate at the intersection of science and business. * GMP Operations Leadership. Understands the value of organized data management and rigor required for GMP operations and successful audit inspections. Managed GMP stability organization that survived multiple internal/external audits for >10 years without a single observation due to strong documentation practices and nurturing a process oriented culture. * Advisor/Counselor on Scientific Risk Management. Strong decision maker and advisor to senior R&D leadership on drug product development decisions that are grounded both on regulatory guidance (FDA, EMA, and ICH) and scientific rationale. An early adopter of principles of Risk Management. * Seeking challenges that require "hands-on" problem solving and decision making to successfully take products from R&D laboratories to commercial plants for routine production.
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