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Jay Nair

Jay Nair

Director, Research

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location of Jay NairGreater Philadelphia

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  • Timeline

  • About me

    Vice President, CMC, Lykos Therapeutics

  • Education

    • Boston University

      -
      Doctor of Philosophy (PhD) Analytical Chemistry

      Activities and Societies: Debate Team PhD in applications of HPLC & IC in Biotech and Pharmaceutical industries.

    • Indian Institute of Technology, Kanpur

      -
      Master of Science (M.Sc.) Analytical Instrumentation

  • Experience

    • Baxter

      Jan 2001 - Jan 2006
      Director, Research

      Directed R&D of Parenteral products at worldwide facilities including global development partners. Integrated multi-site, multi-culture corporate research teams at newly acquired units into Baxter culture. Ensured that the CMC packages were suitable for global registrations, approval, and successful product launches.

    • Cephalon

      Jan 2006 - Jan 2010
      Senior Director, Worldwide Drug Development

      Small molecule and biologic products to support toxicology studies and PI, II and III clinical programs. Pre IND to NDA/BLA responsibilities including life cycle management.

    • Teva Pharmaceuticals

      Jan 2010 - Jan 2013
      Senior Director, Global Branded R&D

    • Bristol-Myers Squibb

      Jan 2013 - Jan 2015
      Executive Director - Biologics

      Biologics Division, Hopewell, NJ

    • CMC Consulting LLC

      Jan 2015 - May 2020
      Managing Partner and CMC Due Diligence Global Expert

      Consultant to the Pharma and Biotech industries. Transforming productivity and compliance levels of Quality Control and Drug Development laboratories.Global Subject Matter Expert (SME) consultant to top three Strategy consulting firms of the world such as Accenture and McKinsey.Coaching Pharma and Biologics companies on Project Management applications in drug development to enhance efficiency and productivity. Provide advice to ensure Data Integrity.

    • Pfizer

      Aug 2016 - May 2017
      Global Regulatory Lead

      Led regulatory interactions with FDA for novel Oncology drugs. Point person for worldwide regulatory interactions including Medical and Clinical filings. Led regulatory teams for successful fast-track drug approvals.

    • Lykos Therapeutics (formerly MAPS PBC)

      Apr 2020 - now

      Prioritizing Public BenefitWe are pioneering a new kind of pharmaceutical company that prioritizes public benefit over profit and is committed to sustainability, accountability, and transparency.Advancing Science & Mental HealthWe are conducting high-quality scientific research at the cutting edge of mental health and psychedelic research. We are committed to open science and regularly publish our findings in leading academic journals.

      • Vice President, CMC

        Mar 2024 - now

      • Head of CMC

        Apr 2020 - Mar 2024

  • Licenses & Certifications

    • Project Management Professional