Gary Rea Email & Phone Number

Drink and eat a lot

Bellevue, Wa

Greater Seattle Area

Bellevue, Wa

• Participated with the development of the clinical forecasts and supply strategies.• Worked with Manufacturing and Clinical staff to ensure the bulk supply was available when needed.• Assisted with the development and management of timelines associated with delivery of investigational product and ensured that supplies were available when needed.• Tracked supply inventory including delivery of clinical supply to clinical sites/depots, reviewed shipping documentation, tracked shipments, etc. for complex global clinical trials.• Coordinated labeling and packaging activities at vendors; coordinated the review and approval of labels, master packaging/labeling batch records, and executed batch records.• Participated in the development, testing and implementation of IxRS systems• Developed strong internal collaboration with all participating functional units• Contributed information and recommendations to clinical strategic planning and budgeting• Established and maintained compliance to all state, federal and international regulations.

Seattle, Wa

• Managed the daily purchasing and logistics for CTI clinical and commercial manufacturing / packaging, including procurement, movement and tracking of finished goods, raw materials, WIP and samples• Processed key product movements information into tracking systems, ERP and spreadsheets• Developed models that supported the planning and budgeting of total costs to support clinical and commercial manufacturing and packaging• Developed, analyzed and negotiated contracts to support manufacturing and packaging activities• Developed and maintained effective interfaces with key quality and operational external and internal customers

Seattle, Wa

• Primary liaison and project manager for clinical supply related activities in support of ZymoGenetics (BMS) products in development.• Outsource manufacturing project manager for other development projects.• Developed project plans, monitored budgets, issued manufacturing and packaging requests and helped prioritize clinical production activities• Managed and updated supply component of the various Drug Development Plans• Assisted with the IVRS development activities and use of the IVRS for a number of ZymoGenetics (BMS) projects• Developed and maintained effective interfaces with key quality and operational external and internal customers.• Person-in-the-plant for outsourced drug product manufacturing and packaging of clinical supplies.• Reviewed and approved vendor documents such as batch records, validation records, etc.• Assisted with the writing, reviewing, and submitting of regulatory submissions.• Assisted with clinical and commercial forecasts and budgets.• Developed procedures and policies relevant to supply chain, vendor selection and management.

Seattle, Wa

• Identified, audited, and contracted vendors both domestic and international to support the clinical and commercial manufacturing, labeling and packaging of CTI drug product utilizing experience in the pharmaceutical industry, knowledge of contract development, and strong negotiating skills.• Coordinated and managed all aspects of finished product manufacturing and clinical supplies packaging (including on-site management) to ensure that all activities are in full compliance with cGMPs and company policies.• Developed procedures, policies and training relevant to the day-to-day operations within CTI manufacturing operations as well as interactions with the various contracted vendors.• Utilized project management software to develop and track progress of current products.• Assisted with all forecasts and managed budgets relevant to all finished product for clinical and commercial packaging/distribution activities.• Assisted with the writing, reviewing, and submitting of the NDA and MAA and supplements for CTI commercial product.