David Martini Email and Phone Number
David Martini work email
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David Martini personal email
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Experienced in the biomedical / biotechnology arena, inclusive of stem cell isolation, media manufacture, device / pharmaceutical testing, immunological assays, tissue culture, animal and human study model development, and related regulatory and quality assurance functions.Regulatory Affairs Management | BiotechnologyEmail: dkm.ncr.li@gmail.comCurrently looking for full-time positions and consulting opportunities in the US and SE Asia, in the biomedical industry utilizing a background in medical device, pharmaceutical, and biologic, research and development, and associated Regulatory and Quality Assurance matters.Communicate effectively with people from diverse cultures, languages, education, and training. I have served in supervisory, managerial, and directorial positions in academia, private sector, and government environments for most of my career.COMPETENCIES:Regulatory Affairs Consultant for cardiovascular medical devices, biologics, & combination therapy-based clinical studies. Performed Legacy Management. reviews for major manufacturerTechnical / Scientific Writing IRB & IACUC protocols, journal articles, CAPA reports, government & sponsor reporting, SOP’s, and protocols.Absorption, Distribution, Metabolism, and Excretion studies to support an INDI for the sponsor.Developed a reproducible pulmonary injury model for testing of invasive and non-invasive medical devices used in support of an Investigational Device Exemption (IDE).Regulatory / Quality Assurance ( Director / Manager ) for manufactured media products and licensed cell lines, contract laboratory services, and client clinical sample storage / banking.Quality Assurance Skills: validation of assays, equipment, and software; SOP writing; GXP practices, and safety; GLP study inspections Establishment of GMP stem cell and media manufacturing laboratories. Internal audits and CAPA.Please contact me at (570) 994-9086 with any biotech regulatory or quality assurance management opportunities.
Oriel Stat A Matrix
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Senior Management ConsultantOriel Stat A Matrix Jan 2017 - PresentWashington, Dc, UsRegulatory Affairs and Quality Assurance consulting for the Life Sciences and Medical Industries.
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Owner/ConsultantDkm International Enterprises Dec 2012 - PresentConsultant for business development and performance of non-clinical and clinical trials, medical device, pharmaceutical, biologic, and cosmetic registration and distribution in Southeast Asia, primarily the Philippines and China.
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Regulatory/Quality Assurance ConsultantOxford International May 2013 - Jun 2013Beverly, Massachusetts, UsPerformed Legacy Management Review for a Major Orthopedic Device Manufacturer (Synthes). -
Regulatory SpecialistThe Methodist Hospital, Debakey Heart And Vascular Center Through Pulse Staffing Aug 2010 - Dec 2010Regulatory Specialist 08/10-12/10Liaison for Sponsors, PI’s, Clinical Trial Coordinators, IRB and Regulatory authorities. Wrote and processed protocols, RE, SAE, and associated regulatory documents for FDA regulated drug and device clinical trials. Prepared/reviewed internal documentation for Internal, sponsor, and 3rd party audits.
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Regulatory Affairs And Laboratory ManagerIncell Corporation Mar 2008 - Jan 2009UsBiotech Firm that manufactures culture media, licenses cell lines, performs contract research and cGMP stem-cell manfacturing -
Laboratory SupervisorT.R.U.E. Research Foundation / U.S. Army Institute Of Surgical Research Jun 2003 - Feb 2008Conducted large animal research related to chemically induced respiratory injury/hemorrhage with subsequent testing of biomedical devices (pulmonary assist, hyperspectral imaging, & laser imaging). Designed GLP study for an IDE submission to the FDA. Submitted IACUC protocols, performed data analysis, scientific writing.
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Research Assistant Iv/ Lab ManagerCase Western Reserve University Jul 2001 - Apr 2003Cleveland, Oh, UsSupervised laboratory operations for primary investigators: core ELISPOT & Beta-counting facility; 300 cage mouse colony, trained students, visiting scholars and scientists (domestic & international) . Budget oversight of multimillion dollar grants for 2 PI's. Wrote and submitted IACUC protocols for the use of up to 43,000 mice over a 3 year period. -
Director Of Regulatory AffairsCellular Technology, Ltd. Laboratories Nov 2001 - Mar 2003Established and implemented GLP for immunological assay (ELISPOT) contract services. Developed SOP's, staff training and proficiency testing, documentation, materials/sample tracking, etc.
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Research AssistantUniversity Of Texas Health Science Center Feb 2000 - May 2001Researched catalytic antibodies for therapeutic use: wrote IRB and IACUC protocols.; performed animal immunization studies;selected clones; conducted molecular studies (RIA, qRT-PCR); synthesized immunogens and liposomal VIP.
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Tissue Culture Laboratory Supervisor/Research AssociateShriners Hospital For Children Jan 1994 - Feb 2000Supervised skin cell culture facility to study cytokine production and optimize cell growth in cultured skin cells for/from burned patients: designed/wrote protocols and reports.; oversight of equipment maintenance, and staff training (safety, culture and molecular techniques). Conducted metabolic studies in a septic pig model.
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Research Associate & Laboratory SupervisorUniversity Of Texas Medical Branch Aug 1987 - Feb 1991Conducted human gallstone and gallbladder cancer studies in conjunction with Merck Pharmaceuticals (Liaison to Merck's CRA); human pharmacokinetic studies in support of the use FDA approval of drugs.Moved laboratory and samples from Philadelphia to Galveston and re-established the facility and staff
David Martini Skills
David Martini Education Details
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The University Of Texas Medical BranchPharmacology And Toxicology -
Uc San DiegoRegulatory Affairs
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University Of DelawareBiology
Frequently Asked Questions about David Martini
What company does David Martini work for?
David Martini works for Oriel Stat A Matrix
What is David Martini's role at the current company?
David Martini's current role is Biotechnology, Biomedical, and Regulatory Affairs | Quality Assurance | Medical Device | Research | Pharmaceutical.
What is David Martini's email address?
David Martini's email address is da****@****ail.com
What schools did David Martini attend?
David Martini attended The University Of Texas Medical Branch, Uc San Diego, University Of Delaware.
What skills is David Martini known for?
David Martini has skills like Biotechnology, Regulatory Affairs, Cell Culture, Clinical Research, Fda, Glp, Clinical Trials, Gmp, Pharmaceutical Industry, Good Clinical Practice, Cro, Medical Devices.
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