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Alex Simone is listed as Global Consumer Products Professional at GXP SYSTEMS CONSULTING, LLC, based in Somerset, New Jersey, United States. AeroLeads shows a work email signal at hillspet.com and a matched LinkedIn profile for Alex Simone.
Alex Simone previously worked as Principal Consultant at Gxp Systems Consulting, Llc and Associate Director, Oral Health Care Non-Clinical Research at Johnson & Johnson Consumer Health Care. Alex Simone holds Ph.D., Food Microbiology from Rutgers University.
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An accomplished PhD level manager and researcher with a diverse background in Consumer Products encompassing Microbiology, Quality and Product Development. Hands-on experience in developing and communicating technical product information for regulatory submissions, as well as, for consumers, oral health care professionals and the professional sales force. Extensive experience in microbiological and Quality testing program development and implementation, Oral Care product development and clinical testing for both humans and pets. Exceptional interpersonal, verbal and written communication skills with a unique ability to effectively communicate complex technical information and concepts to a non-technical audience.Specialties: -Oral care and personal care product claims development and substantiation including OTC drugs.-Assessing GMP vulnerabilities: tracking microbiological non-conformance issues at R&D and manufacturing facilities; providing CAPA tools and resources for resolution.-Auditing procedures, practices and responses-Conducting formal micro risk assessments at manufacturing and R&D facilities.
Listed skills include Fda, R&D, Validation, Microbiology, and 37 others.
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Specializing in GMP vulnerabilities at manufacturing sites, microbiological risk assessments and Quality systems implementation as well as GCP compliance guidance, clinical site qualifications and assessments and documentation.
Directed the design, execution and documentation of non-clinical studies in support of claims for new product launches, as well as developing testing strategies for the future. Responsible for working closely with Clinical and Regulatory to develop comprehensive efficacy support plans including microbiology, fluoride and tooth whitening studies.Established critical partnerships with internal cross-functional groups to identify, investigate and assess microbiology-targeted actives and technologies, consistent with core business strategies.
Managed the Environmental / GMP Programs of the Global Microbiology Department, including: developing and implementing global strategies for testing, cleaning and sanitizing (C&S), Control Point Monitoring (CPM) and Micro Risk Assessments. Established strong relationships with Technology and Manufacturing partners to enhance Tech Transfer, as well as, building and leveraging strategic alliances with outside organizations. Coordinated Global Microbiology testing and tracking programs among all manufacturing facilities including contract manufacturers.
Managed the Technology operations of the Global Microbiology Department, including development and validation of new and improved methods, and strategies for new and atypical products. Coordinated testing and global quality initiatives among six Regional Technology Centers to improve Tech Transfer on a global basis. Led the harmonization, validation and global expansion of a Rapid Methods testing program, including active evaluation of “next-generation” options. .
Responsible for the development, re-staging, launch of and claims support for professional mouth rinse and dentifrice products, gaining support of professional opinion leaders and regulatory agencies and instructing the COP professional sales force in product attributes. Experience includes: professional concept tests, Phase l and Phase ll clinical designs and execution, authoring the CMC sections of INDs and presenting the findings to the FDA.
Exploited traditional Oral Care principles to develop an Oral Care program for pets, leveraging both mechanical and chemical technologies. Co-led a multi-disciplinary team in the development and launch of oral care products for dogs and cats, the first patented Hill’s products. Responsible for study design, documentation and regulatory strategy for the first oral soft tissue claim allowed by the FDA-CVM for pet food.
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Alex Simone works for GXP SYSTEMS CONSULTING, LLC.
Alex Simone is listed as Global Consumer Products Professional at GXP SYSTEMS CONSULTING, LLC.
AeroLeads has found 1 work email signal at @hillspet.com for Alex Simone at GXP SYSTEMS CONSULTING, LLC.
Alex Simone is based in Somerset, New Jersey, United States while working with GXP SYSTEMS CONSULTING, LLC.
Alex Simone has worked for Gxp Systems Consulting, Llc, Johnson & Johnson Consumer Health Care, Colgate Palmolive, Colgate Oral Pharmaceuticals, and Hill'S Pet Nutrition.
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Alex Simone holds Ph.D., Food Microbiology from Rutgers University.
Alex Simone is listed with skills including Fda, R&D, Validation, Microbiology, Gmp, Sop, Quality System, and Technology Transfer.
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