Kirk Douglas Mba, Ph.D. Email and Phone Number
Kirk Douglas Mba, Ph.D. work email
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Kirk Douglas Mba, Ph.D. personal email
Senior scientist with extensive experience (16+ years) in quality assurance and scientific regulatory (FDA, BSI, ISO) affairs in the medical device industry seeking new, exciting and challenging opportunities. Strong project management with leadership, validations, change management, team building, cGMP, sterility, sterilization, and operations management skills as evidenced in various project implementations resulting in over USD$4.4 million annual savings (2019). Developed manufacturing refinement strategies pioneering a significant change in the US intra-ocular lens (IOL) industry regulations effecting a reduction in endotoxin limits from 20 EU/Dev to 0.12 EU/Device by the US FDA for future IOL submissions (2009). Further experience (10+ years) in project and change management, validations, FDA pre-market approvals (PMA) and 510(k) submissions, team building, strategic leadership, business analytics for targeted manufacturing process efficiency improvements, medical device/drug product development, product formulation and management of occupational health and safety practices in the workplace.Interests: science, microbiology, biosecurity, quality assurance, quality operations, pharmaceuticals, biologics, Six Sigma, Lean manufacturing, medical devices, regulatory affairs, sterilization, sterility, validation, change management, economics, business development, manufacturing, molecular biology, medicine, epidemiology, NGS, operations management, entrepreneurship, pharmacoeconomics, logistics, health, healthcare, bioinformatics, biotech/pharmaceutical industry, strategic leadership, and business.
Springer Nature Group
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Associate Editor - Tropical Diseases, Travel Medicine, And VaccinesSpringer Nature GroupChrist Church, Barbados -
Associate Editor - Tropical Diseases, Travel Medicine, And VaccinesSpringer Nature Group Jan 2024 - PresentNew York, New York, United StatesThe journal considers basic, translational and applied research, as well as reviews and commentary, related to the prevention and management of healthcare and diseases in international travellers. -
Advisory Board MemberShomea Oct 2023 - PresentSHOMEA exists to educate, evaluate, diagnose and rehabilitate people suffering from hearing impairment, speech impairment, physical disabilities and populations on the African continent. -
Director, Centre For Biosecurity StudiesThe University Of The West Indies Cave Hill Campus Jul 2020 - PresentBarbados -
Co-Chair Of Environment Working Group Of H3E Caribbean InitiativeHarvard/Mgh Center On Genomics, Vulnerable Populations, And Health Disparities May 2021 - PresentMassachusetts, United StatesTo coordinate the systematic literature reviews and research on environmental exposure impacts on human health and heredity (-onimcs approach) in the Caribbean as part of the H3E Caribbean Initiative.The Jamaica Cancer Care and Research Institute (JACCRI), the Harvard/MGH Center on Genomics, Vulnerable Populations and Health Disparities and The University of the West Indies West Indies (UWI) combine to develop the H3ECaribbean Initiative.The H3E Caribbean Initiative is modeled after the successful H3Africa (Human Heredity and Health in Africa) programme envisioned by Dr Charles Rotimi, director of the NIH Center for Research on Genomics and Global Health, H3ECaribbean will advocate for a substantial investment in the health research infrastructure needed to participate in international genomics studies. These include biobanks, electronic health records, longitudinal epidemiological data and cancer registries.Selected by the Committee of Deans of The UWI’s Faculty of Medical Sciences as its signature initiative to celebrate ‘One UWI’ across all medical school campuses, H3ECaribbean aims to build the health research infrastructure needed to investigate genomic, environmental, and social influences on the etiology of chronic diseases in the region. The initiative seeks to ensure inclusion of persons from the Caribbean in cutting-edge global health research.
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Special Issue EditorMdpi Oct 2021 - Mar 2022Climate Change and Viral Zoonoses -
Independent Business OwnerAmorsa Scents Feb 2011 - Jul 2020Barbados• Developed and launched a variable selection of niche luxury fragrances for the first time in Barbados & Caribbean using novel local natural perfumery ingredients.• Entrepreneurial acumen illustrated as the first niche perfumer in Barbados with 5+ years of digital marketing, strategic planning, procurement, financial planning, and luxury brand management experience. -
Chairman Of Health & SafetyLenstec, Inc. Mar 2012 - Jun 2019Barbados¤Developed risk assessments for ethylene oxide (EtO) occupational exposure for Sterilization department and staff.¤Handled staff occupational health complaints and led investigations. -
Senior Microbiologist/Regulatory Affairs ManagerLenstec, Inc. Mar 2008 - Jun 2019Barbados• Oversee, lead, and coordinate all functions of the QA/Micro-Laboratory Department including managing junior microbiology laboratory staff, process validations, sterility testing, sterilization validations, SOPs, OOS investigations, scientific regulatory issues, MRB and CAPA management.• Demonstrated knowledge of technical regulations including FDA 21 CFR 820, 1270 and 1271, ISO 9001, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC) and other National and International regulations and standards evidenced by leading scientific regulatory affairs and audits pertaining to US Food & Drug Administration (FDA) and British Standards Institute (BSI), ISO & Korean FDA.• Demonstrated understanding of structured product development processes, validations, change management, Lean, 5S and Six Sigma, CAPA investigations, cGMP, FMEA and quality risk assessment, regulatory and quality requirements through team-driven FDA 510(k) submissions for new Class III medical devices. • Refined medical device manufacturing process to reduce microbial contamination (contamination control) for FDA registration in the US market resulting in the lowest levels of endotoxin on IOL products on the US and global market (2008).• Developed and implemented endotoxin product testing regime changes resulting in > US$100K annual savings (2009).• Designed, coordinated and implemented specific manufacturing process improvements to reduce process rejects from 17% to 2.5% worth approximately USD$2.8 million annual savings (2016).• Designed, coordinated and implemented specific manufacturing process improvements (in-process sterilization) to reduce process rejects worth approximately USD$1.5 million savings (2018). -
Quality Assurance MicrobiologistLenstec, Inc. Oct 2002 - Mar 2008BarbadosOversee and coordinate all functions of the QA/Micro-Laboratory DepartmentCreate and update standard operating procedures to ensure regulatory compliance.Develop laboratory testing procedures to support medical device manufacturingSolve microbial contamination issues in manufacturingLead microbiology specific audits by regulatory bodies including Food & Drug Administration (FDA) and British Standards Institute (BSI) -
Veterinary Laboratory TechnicianVeterinary Service Laboratory Sep 2001 - Sep 2002Barbados¤Processed clinical veterinary samples for diagnosis of animal health¤Microbiological testing of veterinary samples
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Summer StudentThe Hospital For Sick Children May 2001 - Aug 2001Toronto, Ontario, CanadaPreparation of electron microscope grids for electron microscopy of clinical stool samplesPreparion of patient blood samples for clinical virological testing
Kirk Douglas Mba, Ph.D. Skills
Kirk Douglas Mba, Ph.D. Education Details
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Merit Honours -
Medical Microbiology -
Microbiology -
Microbiology -
Microbiology
Frequently Asked Questions about Kirk Douglas Mba, Ph.D.
What company does Kirk Douglas Mba, Ph.D. work for?
Kirk Douglas Mba, Ph.D. works for Springer Nature Group
What is Kirk Douglas Mba, Ph.D.'s role at the current company?
Kirk Douglas Mba, Ph.D.'s current role is Associate Editor - Tropical Diseases, Travel Medicine, and Vaccines.
What is Kirk Douglas Mba, Ph.D.'s email address?
Kirk Douglas Mba, Ph.D.'s email address is kd****@****tec.com
What schools did Kirk Douglas Mba, Ph.D. attend?
Kirk Douglas Mba, Ph.D. attended University Of Warwick - Warwick Business School, The University Of The West Indies Cave Hill Campus, The University Of The West Indies Cave Hill Campus, University Of Toronto, The University Of The West Indies Cave Hill Campus.
What skills is Kirk Douglas Mba, Ph.D. known for?
Kirk Douglas Mba, Ph.D. has skills like Problem Solving, Medical Devices, Microbiology, Pcr, Elisa, Gmp, Virology, Fda, Cell Culture, Research, Glp, Molecular Biology.
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