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SENIOR EXECUTIVELead People | Influence Stakeholders | Build Consensus Collaborative, self-motivated executive specializing in pharmaceutical product development, technical operations and regulatory affairs. Proven expertise in the commercialization of over 25 products, negotiation of international regulatory approvals, leading global organizations of 100+ employees and managing budgets of up to $30 million.Persistent and team-oriented senior-level leader. My professional motto is “failure is not an option” and I doggedly strive to implement improvements, overcome obstacles and execute strategic plans to ensure corporate, team, and individual success.Expertise in product development and commercialization, technical operations, Six Sigma, US Food and Drug Administration (FDA) and global regulations and equipment engineering and qualification. Successfully lead people and projects to enhance operational success.
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Vice President, Cmc And ManufacturingSling Therapeutics May 2022 - PresentAnn Arbor, Mi, UsResponsible for all aspects of drug substance and drug product development including analytical, formulation, process, package and engineering. Responsible for all supply chain aspects of our drug substance and drug product including manufacturing, scale up, transfer and plant and product support. -
PresidentDadino Consulting, Llc 2013 - PresentConsultants to the biotechnology, pharmaceutical and medical device industries. We specialize in:-Product development and commercialization-Technical operations and plant/product support-Chemistry, manufacturing and controls section writing-Global regulatory product approval negotiation-Address FDA 483 and Warning Letter observations-Company acquisition due diligence-Drug delivery and drug/device combination product development, commercialization and regulatory strategy o Wrote CMC section/design dossier for multiple clients o Represented several clients in face to face FDA meetings o Collaborated with cross functional team to establish regulatory strategy for pharmaceutical client o Led formulation and process development at contract research organizations for several virtual clients o Performed diligence for the acquisition of a new product line o Performed diligence for the selection of a contract manufacturing organization for a start-up company
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Vice President, Cmc And Supply ChainPalladio Biosciences, Inc., A Centessa Company Sep 2020 - May 2022Responsible for all aspects of drug substance and drug product development including analytical, formulation, process, package and engineering. Responsible for all supply chain aspects of our drug substance and drug product including manufacturing, scale up, transfer and plant and product support. Responsible for company wide quality assurance.
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Senior Vice President, Cmc And ManufacturingForesee Pharmaceuticals, Inc. 2020 - Sep 2020Responsible for technical operations and manufacturing for all products.
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Vice President Pharmaceutical Development And OperationsOrchestra Biomed 2018 - 2020Responsible for all aspects of drug substance and drug product development including analytical, formulation, process, package and engineering. Responsible for all supply chain aspects of our clinical product including manufacturing, scale up, transfer and plant and product support. -
Vice President, Pharmaceutical Development And ManufacturingAclaris Therapeutics, Inc. 2017 - 2018Wayne, Pennsylvania, UsResponsible for all aspects of pharmaceutical product development including analytical, formulation, process, package and engineering. Responsible for all supply chain aspects of our clinical and commercial products including manufacturing, scale up, transfer and plant and product support. -
Vice President Development And Technical OperationsJohnson And Johnson 2011 - 2013New Brunswick, Nj, UsProvide development services across all sectors of J&J (Pharmaceutical, Consumer and Medical Device/Diagnostics) with a pharmaceutical focus. Expert in the development and regulatory filing of combination products.o $300 million in sales recaptured by identifying the cause of failure in a transdermal product and working with the manufacturing plant to modify the process and re-launch the product into the marketplace.o Identified cause of impurity in the flagship over-the-counter medication to win FDA approval for continued marketing and to recoup incalculable sales, customer allegiance and brand trust. -
Vice President, Pharmaceutical Development And Technical OperationsJohnson And Johnson 2001 - 2011New Brunswick, Nj, UsLed the organization responsible for the development of all pharmaceutical attributes and continued technical operations support of combination products, primarily drug eluting stents. Directed the functions of analytical development, formulation development, process development, engineering and package development. Responsible for input to global regulatory filings and regulatory negotiations.o Led multiple new product development programso Member of the product portfolio management committeeo Wrote several CMC sections for successful regulatory filingo Authored new policies and procedures to govern drug-device combination products and educated medical device engineers on pharmaceutical requirements.o Hired and trained a 100-person pharmaceutical development and technical operations team located in five global locations.o Negotiated global approval of the first-ever drug eluting stent resulting in $1 billion in first year sales.o Positioned team as corporate experts to leverage success with combination product development and commercialization across all company business sectors leading to millions of dollars of savings.o Consulted and negotiated with the FDA every two weeks to address concerns, cultivate trust and win product approval.o Developed pharmaceutical attributes of the next-generation drug and successfully filed for regulatory product approval.o Met with executive leaders to negotiate development and commercialization functions while allowing each operating company to retain project responsibility and control. -
Sr. Director, Technical OperationsJohnson And Johnson 2000 - 2001New Brunswick, Nj, UsLed the organization responsible for development, scale up, transfer and commercialization of all product dosage forms. Directed the functions of process development, engineering and package development. Provide troubleshooting support to facilities in the Americas and Caribbean.o Selected as one of the executive leaders of an enterprise-wide FDA remediation project.o Contributed to the development of the inaugural integrated supply chain to centralize manufacturing and technical operations.o Millions of dollars saved through plant rationalization and organization right-sizing during the successful merger of three companies -
Senior Director, Technical OperationsRhone-Poulenc Rorer Pharmaceuticals 1997 - 2000Led the organization responsible for development, scale up, transfer and commercialization of all product dosage forms. Directed the functions of analytical development, process development, project management, engineering and package development. Provide troubleshooting support to facilities in the Americas and Caribbean. Highest ranking Operations associate in the North American headquarters.o Led the team responsible for fixing a yield issue for an aerosol product being transferred to a new facility. I was able to review the process, identify the issue, correct the problem, raise yield from 60% to 98% and save over $2 million in waste.o Led the team responsbile for writing and managing the CMC filing of several nasal products.o Successfully led commercialization of a lyophilized injectable antibiotic at a third party manufacturer.o Successfully steered integration of technical operations of two corporations during Aventis mergero Millions of dollars in savings attained by reviewing 60 plants and slating 30 for closure to merge and right-size infrastructure. -
Director, Process DevelopmentLiposome 1990 - 1997Responsible for development, scale up, transfer and commercialization of parenteral products, both liquid and lyophilized. Responsible for all clinical manufacturing.o Revolutionized the formulation and process for the manufacture of liposomes
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Research PharmacistMerck 1985 - 1990Rahway, New Jersey, UsResponsible for the development of sterile dosage forms. Lyophilization subject matter expert.
Ron Dadino Skills
Ron Dadino Education Details
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University Of The Sciences In PhiladelphiaPharmacy -
Temple UniversityPharmaceutical Quality Assurance And Regulatory Affairs
Frequently Asked Questions about Ron Dadino
What company does Ron Dadino work for?
Ron Dadino works for Sling Therapeutics
What is Ron Dadino's role at the current company?
Ron Dadino's current role is Vice President, CMC and Manufacturing at Sling Therapeutics.
What is Ron Dadino's email address?
Ron Dadino's email address is rd****@****jnj.com
What is Ron Dadino's direct phone number?
Ron Dadino's direct phone number is (732)-524*****
What schools did Ron Dadino attend?
Ron Dadino attended University Of The Sciences In Philadelphia, Temple University.
What are some of Ron Dadino's interests?
Ron Dadino has interest in Children.
What skills is Ron Dadino known for?
Ron Dadino has skills like Fda, Biotechnology, Medical Devices, Validation, Drug Delivery, Gmp, Pharmaceutics, Commercialization, Pharmaceutical Industry, Product Development, Technology Transfer, V&v.
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