Vinay Radhakrishnan

About Vinay Radhakrishnan

Management executive with 25+years of experience in product development at Alexion/AstraZeneca, Pfizer, Amgen and Schering-Plough with global experience in developing innovative and biosimilar injectable products• Recognized as a strong leader who has built technical teams for development activities in USA andIndia in multiple functional areas. Responsible for developing a diverse group of managers and directreports at multiple sites (up to 70 colleagues) across different career ladder positions• Deep technical experience in developing monoclonal antibodies, bispecific antibodies, enzymes, drug conjugates, vaccines, AAVs as liquid(vial and prefilled syringes) and lyophilized dosage forms• Transitioned 20+ projects from early development to FIH, 8+ projects from FIH to (e.g, Vectibix®, Prolia®, Temodar® IV), 3 projects to regulatory approval (Nplate®,NIVESTYM and NYVEPRIA)• Demonstrated strong leadership with ability to lead highly effective teams across multiplegeographies (USA, EU and India), define strategies and work effectively across partner lines(bioprocess, analytical, device, manufacturing, regulatory affairs, quality, supply chain)• Proven track record of building strong relationships with Pharmaceutical Sciences functions,Manufacturing (internal sites and external contract sites), Clinical and Commercial teams• Selected as 2018 Global Health Team member for a Pfizer Global Corporate Responsibility programto work with an NGO on a healthcare advancement project in Dar Es Salaam, Tanzania.• Served as Chair of the AAPS Sterile Products Focus Group and have been active in the AAPS Sterile Products Community for 15+ years

Experience

1. Executive Director and Head, Injectable Drug Product Development

   Alexion Pharmaceuticals, Inc.

   Mar 2021 — Present · New Haven, CT, US

   Enable formulation and process development, and manufacturing of patient-centered, differentiated injectable drug products for Alexion’s diverse portfolio from pre-clinical to successful licensure- Strengthen and develop expertise and capabilities for developing Alexion’s diverse portfolio spanning synthetic, peptide, nucleic acid, protein-based modalities and genomic medicine (viral and non-viral) across various liquid & lyophilized, vial, prefilled syringe and cartridge-based presentations- Develop and execute the drug delivery strategies through internal/external partnerships, including integration into drug/device combination products- Accountable for technology transfers of Drug Products to internal and external manufacturing organizations in a phase appropriate manner- Develop and manage the budget and internal resources- Strategize, plan, and direct process characterization and process validation studies for late stage programs to enable robust commercial manufacturing processes- Provide subject matter expertise for regulatory interactions including inspections, audits and is accountable for the technical content of drug product sections of regulatory submissions- Collaborate with appropriate stakeholders to identify and deliver on life-cycle management opportunities for commercial products- Actively seek and achieve alignment on drug product development strategies within Product Development and Clinical Supplies and at an enterprise level with key stakeholders in Research, Global Operations, Global Regulatory Affairs, Quality, Clinical Research/Operations and Commercial organizations- Develop colleagues and the requisite bench strength to deliver on Alexion’s growing R&D pipeline.

Education

• Fairleigh Dickinson University, Madison, NJ

  MBA, Pharmaceutical Management

  2001 — 2004

• Loyola College (Autonomous), University of Madras, India

  BS, Chemistry

  1984 — 1987

• University Department of Chemical Technology, University of Mumbai

  BSc (Tech), Technology of Pharmaceuticals and Fine Chemicals

  1987 — 1990

• University of Connecticut

  Ph.D., Pharmaceutics

  1993 — 2000

• Temple University

  MA, Chemistry

  1990 — 1994

Skills

• Validation
• Life Sciences
• Biotechnology
• Research and Development (R&D)
• Process Simulation
• Analytical Chemistry
• Aseptic Processing
• Gmp
• Protein Chemistry
• Drug Development
• Biopharmaceuticals
• Formulation Development
• Vaccines
• Pharmaceutical Industry
• Sop
• Lifesciences
• Process Optimization
• Biophysics
• R&D
• Formulation
• Technology Transfer