United States
Vast experience in validation and qualification of processes and equipment, regulatory affairs, technology transfer, quality control, and documentation in the pharmaceutical, biotechnology and bulk chemical industry.
Provide CMC regulatory leadership and strategy required to achieve regulatory approvals. Within the strategic function, collaborate closely with multiple scientific, technical, quality, and commercial areas within the biopharmaceutical industry. Provide knowledge, understanding, interpretation and utilization of regulatory guidance's and regulations, as well as industry and government agency best practices and trends Provided services as Global Regulatory CMC Strategist for the Plasma Network of a biotechnology pharmaceutical company. Actually providing support as Director of Quality Assurance for a biotechnology company. Managing the quality systems including performing supplier audits.
Provide manufacturing support on nonconformance investigations.
Develop global regulatory strategies for drug substance and drug product facility, process and product changes. Facilitate the authoring of CMC supplements such as comparability protocols, prior approval variations and annual reports. Lead team readiness for agencies meetings including development and submission of the meeting request, the briefing document and the meeting minutes. Assess drug substance and drug product change proposals and deviations for the potential impact on the registered details in the marketed jurisdictions. Provide training on basic regulatory affairs concepts to quality unit associates.
Manage the drug product process and cleaning validation team which developed and executed validation documentation for equipment performance qualification, process validation including aseptic process validation through media fills, cleaning and sterilization validation in compliance with agencies requirements. Develop validation strategies for new products introduction and manufacturing process optimization. Provide validation assessment for deviations and change proposals. Author process validation section of CMC filings. Participate actively in regulatory agencies site inspections.