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• Senior-level professional with >30 years of experience in the pharmaceutical and biotechnology industries, across both private, start-up companies and public, $XXB companies; focus on strategy, product innovation, pharma development, pipeline progression, lifecycle mgmt.• Experience in multiple dosage forms, including steriles, solid oral (hormonal & non-hormonal) products, liquid orals, semi-solids, injectables, topicals, ophthalmology and ophthalmics, API, etc. Experience in small molecule, big molecule, and monoclonal antibodies development. • Expertise in product development, process evaluation/optimization, technology transfer, validation, packaging, regulatory submission, R&D, CMO/CDMO/CRO selection and contract negotiation, project management, compliance remediation (483, Warning Letter, Consent Decree, FDA Audit, etc.), systems scaling, implementing of PAT, lean manufacturing, and operational excellence (Six Sigma Green Belt)
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PresidentGurukul Pharmaceutical ConsultingIrvine, Ca, Us
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Head Of Us Strategic Development, Pharmacovigilance & Regulatory AffairsVizen Life Sciences Pvt Ltd Oct 2024 - PresentCalifornia, United StatesAs Head of US Strategic Development, Pharmacovigilance & Regulatory Affairs at Vizen Life Sciences, I am responsible for advancing strategic growth and regulatory innovation in the US pharmacovigilance market. Vizen Life Sciences is a global leader in comprehensive drug safety solutions, supporting top-tier pharmaceutical and biotech companies with services ranging from individual case safety reporting to advanced risk management and regulatory compliance.At Vizen, I work alongside a talented team of over 180 professionals—including physicians, pharmacists, and medical writers—who use state-of-the-art AI technology to streamline case processing, signal detection, and safety data exchange. Together, we are dedicated to delivering high-quality drug safety services that uphold the highest standards of patient care and regulatory excellence.
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Senior Director, Pharmaceutical Development & Product InnovationB. Braun Medical Inc. (Us) Aug 2022 - Nov 2023Irvine, California, United States• Led the development of the innovation pipeline, introducing variations in existing products to enhance the injectable drug portfolio. Prioritized and executed selected programs to accelerate pipeline progression.• Oversaw a cross-functional innovation team, managing formulation/chemistry, analytical, and packaging development. Evaluated external products, technologies, and selected CMOs to enhance internal innovations. -
PresidentGurukul Pharmaceutical Consulting 2017 - 2022United States (California, New Jersey, Florida, Etc.)• Specialized in multiple dosage forms, encompassing sterile, solid oral (hormonal & non-hormonal) products, liquid orals, semi-solids, injectables, topicals, ophthalmic, etc. • Proficient in both small and large molecule development, including monoclonal antibodies, compliance remediation (483, Warning Letter, Consent Decree, Audit, etc.), systems scaling for operational efficiency, and implementation of lean manufacturing principles and achieving operational excellence (Six Sigma Green Belt).• Notable achievements include leading the successful launch of a mAB product for a $20B public biotechnology company, overseeing product development and process improvement for a 505(b)(2) private pharmaceutical company, and directing site technical groups for a $1.7B public pharmaceutical company.
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Executive Director, Corporate Pharmaceutical TechnologyAllergan 2014 - 2017Corona, California, United States• Led the Pharmaceutical Technology site groups across seven North America and Asia sites of legacy Actavis. Provided comprehensive technical, strategic, and tactical guidance for various initiatives, including new product development, technology transfers, process and cleaning validation, PAT implementation, and operational excellence programs.• Responsible for network optimization, site selections – internal and external, PT organization restructuring, budgeting, strategic guidance, technology transfers, compliance support, remediation of products and process, risk management of new product launches, marketed product support, process and cleaning validation programs & new technology.• Originally at Watson Pharmaceuticals, which eventually became Actavis, Allergan, and Teva -
Director, Global Pharmaceutical TechnologyAllergan 2002 - 2014Corona, California, United States• Leader of Pharmaceutical Technology, Site Project Management and Compliance Remediation (Product, Process and Computer). • Provide technical, strategic and tactical guidance for Technology Transfers, New Product Development, Process and Cleaning Validation, Operational Excellence program and Compliance Remediation projects for process, product and Part 11.
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Operational Excellence: Site Leader And Global MentorAllergan 2007 - 2011Corona, California, United States• Successfully made transformational changes and led the creation of a comprehensive improvement program which delivered tangible operational & financial performance improvements. • Significantly reduced cost by over 50%, improved efficiencies and reduced write-offs by leveraging systematic problem solving approach.
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ManagerAllergan 2000 - 2002Corona, California, United States• Supervised the validation group responsible for process/cleaning validations, process investigations and manufacturing support.• Originally at Watson Pharmaceuticals, which eventually became Actavis, Allergan, and Teva
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Head Of U.S. Product DevelopmentCaraco Pharma (Sun Pharma) 1998 - 2000Detroit, Michigan, United States• Established and supervised R&D group responsible for product development, technology transfers and process validations of over 25 pharmaceutical products for US markets. -
Senior Research ScientistEli-Lilly Ranbaxy Joint Venture 1988 - 1998New Delhi, Delhi, India• Supervised the product development groups responsible for developing products for American, European, Australian and other world markets.
Mohit Gupta Skills
Mohit Gupta Education Details
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Pharmacy And Pharmaceutics -
Pharmacy
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Operational Excellence -
Delhi AdministrationBusiness Administration -
The Regulatory Affairs Professional Society (Raps)Medical Devices And Pharmaceuticals
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IspePrinciples Of Computerized Systems Compliance
Frequently Asked Questions about Mohit Gupta
What company does Mohit Gupta work for?
Mohit Gupta works for Gurukul Pharmaceutical Consulting
What is Mohit Gupta's role at the current company?
Mohit Gupta's current role is President.
What is Mohit Gupta's email address?
Mohit Gupta's email address is mo****@****son.com
What is Mohit Gupta's direct phone number?
Mohit Gupta's direct phone number is (951)-493*****
What schools did Mohit Gupta attend?
Mohit Gupta attended Delhi University, Delhi University, Villanova University, Delhi Administration, The Regulatory Affairs Professional Society (Raps), Ispe.
What skills is Mohit Gupta known for?
Mohit Gupta has skills like Validation, Technology Transfer, Pharmaceutical Industry, Sop, Pharmaceutics, Gmp, V&v, Fda, Regulatory Affairs, Cleaning Validation, R&d, Capa.
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