Direct outsourcing partnerships with Clinical Testing Laboratories and Contract Manufacturing Organizations (CMOs), ensuring seamless integration with Gilead's operations and objectives. Lead cross-functional internal teams overseeing global outsourcing activities for solid dose, single agent, and combination products, fostering collaboration and alignment across departments. Implement Gilead's robust quality systems across the global outsourcing network, ensuring adherence to regulatory standards and fostering a culture of quality excellence. Allocate annual spending for pipeline and commercial products, strategically investing resources to support key projects and initiatives.

Oversight and assessment of strategic initiatives related to six core organizational service areas.Budgetary oversight. Establishing and maintaining networks with key business leadership.Committee Chair for workforce, learning and growth initiatives.

Spearheaded development and execution of manufacturing process improvements, establishing SMART (Specific, Measurable, Achievable, Relevant, Time-bound) targets to drive operational excellence and enhance efficiency. Developed and implemented metrics to actively monitor and trend data, enabling the assessment of manufacturing performance and identification of areas for improvement. Offered expert regulatory compliance guidance to cross-functional teams for late-stage drug candidates (Phase 2 & 3), ensuring adherence to regulatory requirements and industry standards. Reviewed and approved contracts between GSK and CMO partners, ensuring compliance with regulatory requirements and alignment with organizational goals.

Pharmaceutical Commercialization Technology (PCT) is responsible for commercialization of new pharmaceutical processes from clinical study through product launch and transfer to supply. Activities include process development, scale-up and optimization, interfacing with global network of facilities for product manufacturing and subsequent optimization, validation and filing documentation, and transfer to supply network. Sourcing and management of analytical outsourcing activities performed by contract research organizations.

The main responsibilities include the design and execution of experiments that use both biophysical and bioanalytical methods to characterize vaccines. In addition to a solid understanding of the characterization of vaccines, the position also requires extensive knowledge of materials and processes used in commercialization of vaccines. The candidate should possess initiative, independent thinking, scientific knowledge related to formulation, and good communication and collaborations skills due to interactions with inter and intra-departmental teams.Reverse-Phase HPLC analytical method development for therapeutic proteins and vaccines.Provided characterization support for in-process and formulated therapeutic proteins and vaccines.Designed and carried out analytical studies to improve current methodologies.Author scientific memos, reports and analytical methods.Provided training technical transfer of analytical methods.Provided High-Throughput analytical support for in-process vaccine formulation.Provided training and user support as acting HPLC system software liaison.