Ce que je fais
Results-driven, forward-looking pharmaceutical project manager delivering comprehensive analytical solutions to help pharmaceutical and nutraceutical companies bring products to market efficiently and confidently. Experienced with CDMO’s, legacy pharma, 503A/B’s, pharmacies, nutraceuticals, hematology, and GLP1’s.
For over 14 years, I’ve partnered with manufacturers and clients to ensure regulatory compliance and product quality through expert analysis and project management, including:
-Method development, validation, verification, and transfer to provide reliable results
-Process validation testing to confirm your manufacturing excellence
-Release, Stability, and Raw Material testing to guarantee product quality and safety
-Custom formulation support to enhance product development and quality
-Technical documentation to meet regulatory requirements
-Utilization of Project Management Software (Monday, Trello, Atlassian, Smartsheets, Microsoft Project/Loops) to help teams plan, execute, and monitor projects through a centralized platform for task management, resource allocation, communication, and progress tracking – leading to improved collaboration, better project visibility, and completion of projects on time and within budget.
-Business and process efficiency analysis to manage costs and capitalize on market trends
-Forward-looking planning and implementation of software tools such as LLM’s to enhance and streamline research and workflows.
-Experience in contract-labs, in-house labs and production, R&D Analytical, QC Analytical, and Regulatory Affairs Departments
My diverse experience across QC and R&D departments, combined with creative problem-solving abilities, enables me to tackle your most complex analytical challenges across all dosage forms – from tablets and capsules to injectables, creams, oral solutions, and beyond. I specialize in developing practical and dependable solutions that balance technical excellence with regulatory compliance to help you achieve your product development and manufacturing goals.