Head, Global QC including Vaccines, Biopharm and Small Molecules

Site manufacturing leader, successfully led completion of manufacturing suites construction, commissioning and qualification, building new team and full operationalization in less than one year.

A key member of a new Single Use Facility build out User team. Led development and implementation of enterprise-wide CMC manufacturability standards for biological products (DS, DP and devices, including analytical methods and direct materials) for late stage pipeline delivery and commercial life cycle management to reduce cost, improve quality and efficiency through innovative solutions to meet changing business and regulatory requirements. Standards were successfully applied for accelerated novel product submissions and approvals. I provided routine update and presentations to Pharma Technical executive management members to ensure timely alignment. Project goals with aggressive timeline were met through strong cross-functional collaboration, influence management and decision making.Led team of senior leaders responsible for technology transfer and implementation of new biotechnology products' s CMC processes (DS and DP). Cross-function team activities included manufacturing process transfer, validation and execution strategy development and implementation, risk management, process and product control strategy, global regulatory CMC section submission authorship, inspection readiness, project management and interaction with global regulatory authorities.Developed novel flexible manufacturing strategy that led to $x0m+ savingsSuccessfully developed and implemented risk mitigation plan for accelerated CMC program - the plan was utilized for approval of novel product.Successfully implemented new commercial mAb process at a commercial production site for HA license, under budget and within timelineKey team player and designer of a new global regulatory change management business process to effectively and efficiently manage post-marketing regulatory changesDesigned long range planning process for product sourcing decisions of products under accelerated development

Led global quality control team responsible for the life cycle management of analytical methods, analytical technologies and reference standards for all commercial biotech products globally as well as to be commercialized products.Responsible for leading method development and validation, specification updates, reference standard qualification and related regulatory submissions.Author and reviewer of several CMC sections for global commercial regulatory submissions.Direct interactions with global health authorities e.g. FDA, EMA, PMDA, SFDA.Developed and implemented Quality systemManagement a large technical QC staff.

Led Quality Assurance (QA) group in Product Development for Clinical trial product testing and direct materials as well as all corporate pharmaceutical reference standards.Reviewed and approved all corporate product specification for release and stability.Supported CMC submission, including QbD and control strategy establishment.Managed global CMO, including audits and quality agreements.Led corporate CMC team to address Warning Letter as well as assessment of all other products for potential failure mode - outcome was endorsed by VP of Quality.Developed and implemented Quality systemsSponsored Six Sigma projects for process improvement

Responsible for QC laboratory providing non-routine support to global API manufacturing and process validation for multiple commercial biotech products through new method development and validation, analytical testing for process validation and manufacturing investigations. Successfully submitted regulatory changes, negotiated on regulatory responses with various global agencies.Led correction solution development and implementation for a Warning Letter, which were accepted by the FDA.