Michael Rubin, Ph.D. Email and Phone Number
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Mike is a results-oriented Microbiologist with extensive Product Development knowledge and experience in Consumer Health Care, Personal Care and Food Industries. He has a proven record in developing new products and solving microbiologically-based problems. Mike is skilled in managing Microbioloby laboratories, Contract Manufacturing and Contract Product Development programs. He effectively collaborates with Marketing, Sales, Manufacturing, and Technical professionals on cross-functional teams. Mike also has extensive training in GMP, GCP, and GLP regulations.Mike’s accomplishments at include: • Established an in-house microbiology laboratory capable of conducting FDA and EPA antimicrobial assessments, bioburden testing, as well as preservative efficacy testing resulting in cost savings and time reductions as compared to external laboratories.• Designed and conducted in-house and external Clinical Studies that resulted in the launch of a new OTC nasal decolonizer (skin antiseptic).• Designed and executed the in vitro laboratory studies that were the basis for the successful 510K submission to FDA for the Prevantics Device Swab for the purpose of disinfecting needleless IV hubs.Specialties: Product Development | OTC | Personal Care | FoodApplied Microbiology | Microbiologist Project ManagementExternal Contract ManufacturingNew Technology | Innovation FermentationGMP | GLP | GCPQuality Control MicrobiologyPreservative efficacyEPAFDAQualityValidationsClinical StudiesIRBProtocolsInvestigator BrochureClinal Site Monitoring
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Microbiology ManagerDmi Personal Care Jun 2020 - PresentWharton, New Jersey, Us -
Director, Microbiology LaboratoryTroy Corporation Mar 2019 - Nov 2019
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Director Of MicrobiologyTopiderm Sep 2018 - Feb 2019Olen, Antwerp, Be -
Principal Scientist Microbiology R&DPdi Apr 2012 - Feb 2018Woodcliff Lake, New Jersey, UsResponsible for conducting antimicrobial assessments of skin antiseptics and surface disinfectant formulations and technologies for use in healthcare and food service settings.•Established an in-house microbiology laboratory capable of testing PDI products that includes antiseptics (NDA and OTC) and EPA regulated disinfectants in both non-woven and spray formats.•Managed junior Scientists to enable them to reach their full potential.•Developed the capability to test Clostridium difficile via the EPA germicidal carrier test thereby reducing costs.•Developed new policy for evaluating products for preservative efficacy based upon product category and compendia methodology to streamline the product development process.•Conducted in vitro and in vivo clinical testing for submission to FDA for NDA antiseptics as well as 510K medical device submissions resulting in the launch of new antiseptic/disinfectant productsDeveloped and reviewed IRB submission, protocols, and final reportsEnsured Clinical samples were processed in compliance with GCPsWrote research reports based upon data generated from these studiesMonitored Clinical studiesMaintained study files for submission to FDA and EPA •Liaison for external testing thereby eliminating duplicate efforts from other internal groups.Wrote and reviewed protocolsEnsured compliance with protocols by monitoring study sites Reviewed dataWrote summary reports based upon data•Biofilm strategy- ensured compliance with EPA regulations as well as developed a research strategy for further claims consideration in order to develop products to kill biofilm in hospital, food preparation, and household settings.•Microbial content and identity- Ensured raw materials and finished goods were compliant with microbiological specifications. according to FDA regulations.Identified microorganisms to species using Vitek and Biolog systems as well as classical microbiological techniques. -
Director Product Development, Otc Personal Care Through April 2011Prestige Brands, Inc. 2006 - Apr 2011Tarrytown, Ny, UsDirected OTC product development using external laboratories and contract manufacturers for iconic brands including Chloraseptic®, Compound W®, New Skin®, Percogesic®, Dermoplast®, and Little Remedies®.• Developed OTC formulations: Chloraseptic® lozenges, strips, and sore throat sprays.• Reformulated New Skin® Liquid bandage to comply with OTC monographs for antiseptic products.• Expanded the Little Remedies® line of products resulting in a more extensive portfolio of OTC and cosmetic products to treat childhood diseases and symptoms.• Collaborated with Marketing to expand the Little Remedies® line growing the brand in a shrinking economy.• Evaluated new technologies for business development and acquisition opportunities.• Negotiated development agreements and pricing with external resources reducing overall development costs by $500 Million.• Constructed and maintained project timelines to ensure on time delivery of products.•Solved manufacturing problems to successfully meet product demand and streamline operations. -
Research Associate, Oral CarePfizer Consumer Healthcare 1999 - 2006New York, New York, UsManaged a group of three Scientists and two Lab Techs that provided microbiological support for all of Pfizer’s Oral Care Product Development projects.• Developed unique microbiological manual and robotic methods that assessed antimicrobial properties of novel oral care treatments against biofilm and planktonic microbiota resulting in 50% faster delivery time and 100% increase in samples evaluated.•Conducted the internal and external clinical studies which included Kill Kinetics and Minimum Inhibitory Concentration (MIC/MBC) assays to support the in vitro antimicrobial claims of Freshburst Listerine®, Tartar Control Listerine®, and Citrus Listerine® resulting in the granting of the American Dental Association Seal of Acceptance for plaque and gingivitis.• Supported the advertising claims of freshening breath by killing malodorogenic microorganisms for Listerine® Pocket Packs (Coolmint, Freshburst, and Citrus) by developing the protocols and conducting the internal and external clinical studies. -
Senior Scientist, Oral Care | Consumer Health CarePfizer Consumer Healthcare 1992 - 1999New York, New York, UsConducted the antimicrobial assays used to support all Listerine® branded products and for developing unique assays to evaluate the anticalculus efficacy of Tartar Control Listerine®.• Designed assay showing tensile strength reduction of zinc chloride treated in vitro grown calculus.• Developed assays to show zinc chloride treated calculus crystal growth morphology changes.• Performed pH stat assay to evaluate crystal nucleation delay with zinc chloride.• Investigated zinc chloride binding to hydroxyappatite in an in vitro model of my design.• Supported product launch and advertising claims resulting in annual sales of $40 Million. -
Scientist, Quality Control MicrobiologyWarner Lambert Consumer Healthcare 1984 - 1992Performed compendia microbiological assays for the analysis of OTC and confectionary products.• Executed Antimicrobial Effectiveness (preservative challenge) from both US and British pharmacopoeia.• Analyzed foods and confections for microbial content using methods described in the F.D.A.’s Bacteria Analytical Manual.• Conducted microbiological based water analysis as described by the APHA.• Audited manufacturing facilities and associated microbiology laboratories.• Established HACCP plans for manufacturing facilities.• Implemented cleaning validation studies at contract manufacturing sites.• Wrote Standard Operating Procedures (SOPs) and Work Instructions for microbiology laboratories using information mapping.
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Assistant Scientist Through Scientist, Product Development Gums & ConfectionsAmerican Chicle 1981 - 1984Product Development for Chewing Gums and Confections.• Formulated bubble gums using new soft chew gum base technology.
Michael Rubin, Ph.D. Skills
Michael Rubin, Ph.D. Education Details
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Rutgers UniversityMicrobiology -
Inactive-1703030558-Liu BrooklynMicrobiology -
State University Of New York CortlandBiology
Frequently Asked Questions about Michael Rubin, Ph.D.
What company does Michael Rubin, Ph.D. work for?
Michael Rubin, Ph.D. works for Dmi Personal Care
What is Michael Rubin, Ph.D.'s role at the current company?
Michael Rubin, Ph.D.'s current role is Microbiology Manager at DMI Personal Care.
What is Michael Rubin, Ph.D.'s email address?
Michael Rubin, Ph.D.'s email address is mr****@****inc.com
What is Michael Rubin, Ph.D.'s direct phone number?
Michael Rubin, Ph.D.'s direct phone number is 914-524*****
What schools did Michael Rubin, Ph.D. attend?
Michael Rubin, Ph.D. attended Rutgers University, Inactive-1703030558-Liu Brooklyn, State University Of New York Cortland.
What skills is Michael Rubin, Ph.D. known for?
Michael Rubin, Ph.D. has skills like Fda, Gmp, Pharmaceutical Industry, R&d, Cross Functional Team Leadership, Product Development, Glp, Formulation, Microbiology, Biopharmaceuticals, Sop, Technology Transfer.
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