Gary Rea's Location
Bothell, Washington, United States, United States
Gary Rea's Contact Details
Gary Rea work email
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Gary Rea personal email
n/a
About Gary Rea
Professional individual offering Clinical and Commercial Drug Product Manufacturing | Supply Chain Logistics Operations | and Vendor Management
Gary Rea's Current Company Details
R&R
Taking some time off to enjoy the rest of my life...
Gary Rea Work Experience Details
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Laid Back...R&R Jul 2022 - PresentDrink and eat a lot
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Associate Director, Clinical SupplyKartos Therapeutics Jan 2020 - Jul 2022Bellevue, Wa -
Assistant Manager, Global Supply ChainOmeros Corporation Oct 2018 - Jan 2020Greater Seattle Area -
Clinical Supply Chain SpecialistAcerta Pharma B.V. Jun 2016 - Apr 2018Bellevue, 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. -
Sr. Mgr, Mfg Procurement & LogisticsCti Biopharma Dec 2014 - May 2016Seattle, 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 -
Clinical Supplies Project ManagerBristol-Myers Squibb (Zymogenetics - Seattle Site) Nov 2005 - Mar 2014Seattle, 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.
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Associate Director Pharmaceutical MfgCell Therapeutics, Inc. Feb 1996 - Nov 2005Seattle, 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.
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Manager, Pharmaceutical OperationsCytran Inc. (Kirkland, Wa) Jun 1994 - Mar 1995
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Assistant Manager, Clinical ManufacturingProcyte Corporation (Kirkland, Wa) Jan 1993 - May 1994
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Sterile Manufacturing Operations SupervisorSyntex Research (Palo Alto, Ca) Apr 1991 - Jan 1993
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Manufacturing SupervisorNeorx Corporation (Seattle, Wa) Apr 1987 - Mar 1991 -
Production SupervisorSteris Labs (Formerly Carter-Glogau Laboratories), Phoenix, Az Jun 1978 - Apr 1987
Gary Rea Skills
Gmp
Pharmaceutical Industry
Fda
Biotechnology
Validation
Clinical Trials
Sop
Drug Development
Biopharmaceuticals
Technology Transfer
Clinical Development
Quality Assurance
Life Sciences
Pharmaceutics
21 Cfr Part 11
Standard Operating Procedure
U.s. Food And Drug Administration
Regulatory Affairs
Contract Manufacturing
Oncology
Forecasting
Glp
Regulatory Submissions
Gxp
Start Ups
Change Control
Vaccines
Capa
Quality System
Ind
Clinical Research
Cro
Medical Devices
V&v
Gcp
Formulation
Hplc
Lifesciences
Cleaning Validation
High Performance Liquid Chromatography
Good Manufacturing Practice
Regulatory Requirements
Quality Auditing
Gary Rea Education Details
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Biology, General
Frequently Asked Questions about Gary Rea
What company does Gary Rea work for?
Gary Rea works for R&r
What is Gary Rea's role at the current company?
Gary Rea's current role is Taking some time off to enjoy the rest of my life....
What is Gary Rea's email address?
Gary Rea's email address is gr****@****ros.com
What schools did Gary Rea attend?
Gary Rea attended Arizona State University.
What skills is Gary Rea known for?
Gary Rea has skills like Gmp, Pharmaceutical Industry, Fda, Biotechnology, Validation, Clinical Trials, Sop, Drug Development, Biopharmaceuticals, Technology Transfer, Clinical Development, Quality Assurance.
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Gary Rea
Protective & Marine Division Manufacturing & Processing Bdr Sales Manager With The Sherwin-Williams CompanyBaton Rouge Metropolitan Area2sherwin.com, sherwin.com1 +174089XXXXX
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3genzyme.com, gmail.com, crisprtx.com
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4us.ibm.com, patmedia.net, ibm.com, shi.com
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