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Online Resumes with "In vitro Diagnostics"
Biochemist - 20 Years of Experience - Near 91942
Goal-Orientated Scientist with extensive research, product development and manufacture transfer experience. In-Vitro Diagnostics industry. Background in both nucleic acid and monoclonal antibody testing platforms. Enrolled in Regulatory Affairs for Biomedical Certificate Program. Recent education in Forensic Science.
Tags for this Online Resume: Nucleic Acid Amplification, Chemiluminescence, End-Point/Real-Time PCR, TMA , Experimental Design, Monoclonal Antibodies , Assay Development , HPLC / GC, Scientific Writing
Scientific Project Management - Medical Device Development
My expertise & experience is in medical device design and development, from disposable catheters & ostomy products to more complex wound dressings & tube securement devices for critical care/ICU applications as well as in-vitro diagnostics (IVD's). I am most interested in senior level scientific or technical project manager positions (non-IT related). I am a passionate, "hands-on" team leader, accustomed to a dynamic smal...
Ideal Companies: Abbott, Baxter, Becton Dickinson, Biomerieux, BSN Medical, Boston Scientific, Coloplast, Covidien, C.R. Bard, Edwards Life Sciences, Fresenius Kabi, GE Healthcare, Gore Medical, Integra Life Sciences, Medline, Medtronic, Stryker, SynCardia Systems Inc, Teleflex Medical, TransEnterix, Vascular Designs, WuXi AppTec, Wound Management Technologies, & Zenalux Biomedical.
Tags for this Online Resume: Project Management, Research , Medical Devices, In-vitro Diagnostics, Design Controls (DHF), Cross functional leadership, MS Project, Illinois
Clinical Quality Assurance
SUMMARY A results-oriented and performance-driven operation leader with extensive experience in the medical device and in-vitro diagnostics and treatments in healthcare industries. Consistently delivers improvements in customer satisfaction, quality, and product performance. Possesses well-developed analytical skills and an ability to synthesize data into meaningful information for the organization. Close attention to detai...
Tags for this Online Resume: Manufacturing, Product Development, Hematology, Quality, Quality Assurance, Quality Control, Support, Technical Support, Test, Corrective Actions
Biochemist
Summary of Qualifications: Scientist with 20+ years of combined experience within the In-Vitro Diagnostics Devices and Biotech Industries with success as a Bench Scientist in completing a project ahead of time, and co-authoring a report which resulted in a 3 million bonus for Gen Probe.
Tags for this Online Resume: • In-Vitro Diagnostics Medical Devices, • Regulatory Affairs, Scientific Writing, Annual Reports, Research, Manufacturing, Troubleshooting, • Pre-Sub, FDA, 510(k), PMA, • Experimental Design, • Monoclonal Antibodies, Medical Devices, • Nucleic Acid Amplification, • End-Point/Real-Time PCR, qPCR
Clinical Research - 20 Years of Experience - Near 46037
Tags for this Online Resume: Vendor management, Good Clinical Practices, Health Insurance Portability And Accountability Act, Contract negoiations, budget tracking, Problem solving, Cardiac, In vitro Diagnostics, Regulatory
Department Manager - 20 Years of Experience - Near 92128
Areas of Expertise * Business Process Improvement * Environmental Monitoring * Inventory Control & Management * Production Planning & Scheduling * Strategic Planning & Implementation * Process Design & Validation * GMP and ISO 13485 Compliance Recruited to establish Production Reva Medical San Diego, CA Established and directed formal operations functions supporting production of pre-clinical and clinical supplies collabore...
Tags for this Online Resume: Automation, Hazardous Waste, Instrumentation, Integrate, Metrics, Order Processing, Process Improvement, Production Metrics, Management, Good Manufacturing Practices
CEO of Quality/Regulatory Affairs- 19 Years of Experience - New York
SUMMARY Senior Executive with combined technical, regulatory strategy, project management and business experience to build businesses and relationships to deliver new products to market. Over 20 years of experience in medical device, pharmaceutical, biologics, and diagnostic development, including In-Vitro Diagnostic, with market leaders such as Johnson & Johnson, Watson Pharmaceuticals and Mela Sciences. Led worldwide regu...
Tags for this Online Resume: Management, Manufacturing, Product Development, Risk Management, Process Engineering, Engineering, Quality, Quality Assurance, Quality Control, Regulatory, Strategy, Clinical Development, Pharmaceutical, Medical Device, Green Belt, PnL
Scientist Manager - 19 Years of Experience - Near 02864
SUMMARY: Over fifteen years of Research & Development and manufacturing management experience in Biotechnology/In-vitro Diagnostics industry. Broad experience in Research and Development and Manufacturing. HANDS ON EXPERTISE: * Immunochemistry Assay Development for Lateral flow and Microfluidic, Wet Chemistry. * Molecular biology assay development, amplification techniques including PCR & RT-PCR. * Pharmacokinetics and Immu...
Tags for this Online Resume: Research, Research and Development, Diagnostics, Toxicology, Support, Technical Support, Management, Chemistry, Data Analysis, High Performance Liquid Chromatography (HPLC), research, cro
IN-VITRO DIAGNOSTICS AND LIFESCIENCES PROFESSIONAL
Seeking an opportunity in Research & Development, New Product Development, Scientific Affairs or Alliance Management in the In-Vitro Diagnostics industry where, not only can my skills and experience can be best utilized and have a positive impact, and where I can also have a chance to grow and learn.
Tags for this Online Resume: Assay Development, Project Management, Product Development, R, Alliance Management, Scientific Affairs, Subject Matter Expert
Quality Assurance Director - 18 Years of Experience - Near 55379
Summary of qualifications Global Quality System and Regulatory Compliance Experience in Regulated Environments (Medical Device/Pharmaceutical/Food/In-Vitro Diagnostics) including implementation of design controls * Global Regulatory and Quality Compliance (creating processes for Field Actions/point of contact for all recalls with the FDA/806 and monthly reporting) * Regulatory partnering with FDA and International Agencies ...
Tags for this Online Resume: Documentation, Infrastructure, Management, Program Management, Budget Preparation, Budgeting, Development Activities, P&L, Product Development, Project Management
