*Perform the role of Program Lead for Clinical Supply Operations*Assist in order to insure on-time delivery of clinical supplies for studies across the portfolio of products*Assume responsibility from both a lead position as well as hands on for ensuring assigned projects are manufactured, packages, labeled and distributed to time to support all phases (1-4) of required clinical studies*Develop and maintain study-level budgets*Work closely with Supply Planning and Logistics to ensure tasks and supply plans are executed in a timely manner and within budget*Evaluate, select, and implement contract manufacturing, packaging and labeling*Negotiate work orders/proposals, in collaboration with Supply Chain and Logistics and oversee operations*Act as primary liaison with clinical personnel on assigned projects*Participate in the design of overall clinical plans and study protocols. Recommend type and method of packaging, labeling and distribution. Translated protocol requirements and study milestones into an actionable Supply Plan Agreement*Recommend matching placebo drug sources*Assist in developing appropriate strategies for regulatory CMC filing (domestic and international)*Assist in identifying emerging trends, technologies, and best practices and implement as appropriate*Assist in the establishment of SOPs and guidelines related to production planning and scheduling, inventory management, distribution, transportation, disposition of returned/unused materials etc.

Manage the day to day operations of Clinical Supplies department staff and activities. Effectively oversee assigned staff projects to ensure compliance with PPD requirements, client requirements, and all applicable regulatory requirements. Serve as a point of escalation for all project related issues and concerns. Interact with both internal and external management level peers to resolve day to day challenges and issues. This includes but is not limited to the projects budget, contract, and/or third party vendors. Participate in the bidding and/or bid defense activities regarding clinical supplies opportunities.

• Global management and development of sixteen Logistics Coordinators located in 7 countries.• Ensure focused and strategic support in the country/region for effective planning and execution of clinical trial logistics activities. Specifically that trial supplies, investigational materials/products, and samples/specimens are available to be distributed to, or received from, clinical sites in line with appropriate standards, sanofi pasteur SOP’s, and the Clinical teams agree-upon timelines, requirements, and budget. • Routinely interact with the Global and Regional Study Managers within Study Management and Logistics Platform to ensure harmonization and support a global strategic vision contributing to the realization of the objectives. • Collaborate with other Clinical Operations platforms heads, Clinical Development representatives, Clinical Supply Chain and Clinical Supply Unit, Medical Affairs, study sites, and other key clinical trial collaborators (internal and external).• Author Sanofi Pasteur SOP, guidance documents, and operating guidelines. Reviewer of all Clinical Protocols for Logistics sections.• Participate in and guides study team in vendor selection. Develop outsourcing specifications for vendor requests for proposal and scope of work agreements

• Managed project teams and cross-functional activities related to the preparation, packaging, labeling, assembly and distribution of stability, analytical, and clinical trial materials.• Lead two project managers, two senior clinical coordinators, and two clinical coordinators, who are responsible for accounts including potentially critical business relationships and critical cross-divisional work.• Interact regularly with Department Managers and other personnel from various Cardinal Health PTS, Inc. divisions to increase cross-divisional communication and cooperation.• Oversee and manage the financial forecast for clinical supplies manufacturing, packaging and drug procurement on a weekly basis, ensuring that the production schedule reflects the month’s revenue.• Implement and track Key Performance Indicators (KPI’s) to measure team/departmental effectiveness and efficiencies as they pertain to the organizational goals and objectives.• Facilitate the development and training of project management staff.

• Managed multi-phase studies with multiple campaigns, high complexity, and global application / distribution. • Developed and maintained project plans through utilization of MS Project software, and resource management. Ensured that key project milestones were in agreement with customer expectations and were achieved.• Interacted regularly with other personnel from various departments from project exploration phase through completion.• Ensured project compliance with all FDA (cGMP / GCP) regulations.• Corresponded with Finance personnel on timing and follow-up of billing activities.• Excellent communication skills with customers acting as the main point of contact, ensuring that all developments or changes to project plan were conveyed appropriately.

Acted as a liaison between Accupac and its customers regarding scheduling, manufacturing, quality control, and other functions. Quoted orders, coordinated new projects, and provided customer service.

Pharmaceutical packaging department shift supervisor. Responsibilities included supervising and scheduling an eighty-person work force, quality and quantity of production, adherence to GMP, and reconciliation of paperwork.