Senior Management Consultant
CurrentRegulatory Affairs and Quality Assurance consulting for the Life Sciences and Medical Industries.
Jan 2017 - Present
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David Martini Email & Phone Number
Biotechnology, Biomedical, and Regulatory Affairs | Quality Assurance | Medical Device | Research | Pharmaceutical
at
Oriel STAT A MATRIX
1 work email found
@orielstat.com
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Current company
Role
Biotechnology, Biomedical, and Regulatory Affairs | Quality Assurance | Medical Device | Research | Pharmaceutical
Location
New York City Metropolitan Area, United States
Who is David Martini? Overview
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David Martini is listed as Biotechnology, Biomedical, and Regulatory Affairs | Quality Assurance | Medical Device | Research | Pharmaceutical at Oriel STAT A MATRIX, based in New York City Metropolitan Area, United States. AeroLeads shows a work email signal at orielstat.com and a matched LinkedIn profile for David Martini.
David Martini previously worked as Senior Management Consultant at Oriel Stat A Matrix and Owner/Consultant at Dkm International Enterprises. David Martini holds Ms, Pharmacology And Toxicology from The University Of Texas Medical Branch.
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{first_initial}{last}@orielstat.com
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Profile bio
About David Martini
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.
Listed skills include Biotechnology, Regulatory Affairs, Cell Culture, Clinical Research, and 30 others.
Current workplace
David Martini's current company
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11 roles
David Martini work experience
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Owner/Consultant
Current
Dkm International Enterprises
Consultant 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.
Dec 2012 - Present
Regulatory/Quality Assurance Consultant
Performed Legacy Management Review for a Major Orthopedic Device Manufacturer (Synthes).
May 2013 - Jun 2013
Regulatory Specialist
The Methodist Hospital, Debakey Heart And Vascular Center Through Pulse Staffing
Regulatory 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.
Aug 2010 - Dec 2010
Regulatory Affairs And Laboratory Manager
Biotech Firm that manufactures culture media, licenses cell lines, performs contract research and cGMP stem-cell manfacturing
Mar 2008 - Jan 2009
Laboratory Supervisor
T.R.U.E. Research Foundation / U.S. Army Institute Of Surgical Research
Conducted 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.
Jun 2003 - Feb 2008
Research Assistant Iv/ Lab Manager
Supervised 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.
Jul 2001 - Apr 2003
Director Of Regulatory Affairs
Cellular Technology, Ltd. Laboratories
Established and implemented GLP for immunological assay (ELISPOT) contract services. Developed SOP's, staff training and proficiency testing, documentation, materials/sample tracking, etc.
Nov 2001 - Mar 2003
Research Assistant
University Of Texas Health Science Center
Researched 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.
Feb 2000 - May 2001
Tissue Culture Laboratory Supervisor/Research Associate
Shriners Hospital For Children
Supervised 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.
Jan 1994 - Feb 2000
Research Associate & Laboratory Supervisor
University Of Texas Medical Branch
Conducted 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
Aug 1987 - Feb 1991
3 education records
David Martini education
Ms, Pharmacology And Toxicology
The University Of Texas Medical Branch
Regulatory Affairs Essentials Certificate, Regulatory Affairs
Uc San Diego
B.A, Biology
University Of Delaware
FAQ
Frequently asked questions about David Martini
Quick answers generated from the profile data available on this page.
What company does David Martini work for?
David Martini works for Oriel STAT A MATRIX.
What is David Martini's role at Oriel STAT A MATRIX?
David Martini is listed as Biotechnology, Biomedical, and Regulatory Affairs | Quality Assurance | Medical Device | Research | Pharmaceutical at Oriel STAT A MATRIX.
What is David Martini's email address?
AeroLeads has found 1 work email signal at @orielstat.com for David Martini at Oriel STAT A MATRIX.
Where is David Martini based?
David Martini is based in New York City Metropolitan Area, United States while working with Oriel STAT A MATRIX.
What companies has David Martini worked for?
David Martini has worked for Oriel Stat A Matrix, Dkm International Enterprises, Oxford International, The Methodist Hospital, Debakey Heart And Vascular Center Through Pulse Staffing, and Incell Corporation.
How can I contact David Martini?
You can use AeroLeads to view verified contact signals for David Martini at Oriel STAT A MATRIX, including work email, phone, and LinkedIn data when available.
What schools did David Martini attend?
David Martini holds Ms, Pharmacology And Toxicology from The University Of Texas Medical Branch.
What skills is David Martini known for?
David Martini is listed with skills including Biotechnology, Regulatory Affairs, Cell Culture, Clinical Research, Fda, Glp, Clinical Trials, and Gmp.
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