Experience

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  Glatt Group

  • Ramsey, New Jersey, United States

  • Vice President & Head of Pharmaceutical Development

    • Oct 2016 - Present
    • Ramsey, New Jersey, United States

• 

  Glatt Air Techniques

  • Ramsey, New Jersey

  • Executive Director & Head of Research & Development

    • Nov 2016 - Nov 2023
    • Ramsey, New Jersey

• 

  Teva Pharmaceuticals

  • Pomona, NY

  • Associate Director

    • Dec 2012 - 2016
    • Pomona, NY

    Head of R&D Process Engineering & Pilot Plant, Pomona, NY

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  Teva Pharmaceuticals

  • Senior Manager

    • 2009 - 2012

    Lead the R&D Process Engineering Department involved in Process Development of New Products, Scale-up, and Tech Transfer of the Approved Products, Trouble-shooting of issues associated with Commercial Products.

• 

  CVS Pharmacy

  • Staff Pharmacist

    • 2001 - 2012

    Dispensed medical and surgical products as prescribed, provided advice and information on the use and effects of medications, sold non-prescription drugs and related commercial products, interpreted and filled physicians’ prescriptions for customers, verified all patient information before filling a prescription, provided consultation to customers upon filling a prescription and on OTC (over the counter) medicines as required, contacted physicians and benefits providers as necessary to process a prescription, completed third-party insurance forms and other paperwork, provided a professional and confidential environment for customers on all occasions and compounded medications when necessary

• 

  Teva Pharmaceutical Industries Ltd.

  • Pomona, NY

  • Manager, R&D Process Engineering

    • 2007 - 2009
    • Pomona, NY

    Manage, organize, plan, and coordinate all aspects of Process Engineering activities of new products, scale-up, technology transfer from R&D to Operation , product launch and coordinate all aspects of supplement batch manufacture. Partner with R&D, regulatory, sales & marketing, finance and production to schedule, plan and execute new product launches, product optimizations, and supplement batch manufacture. Develop schedules and timelines for assigned products in the post-ANDA stage with milestones up to and including product launch.

• 

  Barr Laboratories

  • Pomona, NY

  • Principal Scientist

    • 2005 - 2007
    • Pomona, NY

    Perform scale up and process optimization experiments using sound experimental design (DOE) to identify, characterize and understand critical process parameters and their effects on in-process and finished product quality attributes. Partner with R&D Product Development during R&D phase, especially during scale up and submission stages to understand critical process parameters and critical quality attributes. Evaluate and qualify multi-source drug components and other pharmaceutical excipients through extensive physico-chemical study characterization. Write and execute protocols for experimental batches and submission batches. Write reports for scale up and submission batches with process data and corresponding analysis using statistical tools. Support regulatory submission preparation (QOS/PDR/QBR) with process development related information and data in close cooperation with R&D (Formulation). Respond to comment/deficiency letters for process related items. Perform data analysis using statistical tools from development and submission for process understanding. Fully evaluate all raw material, in-process, and finished product specifications during scale-up work. Provide technical support for manufacturing troubleshooting activities. Prepare reports, memo’s and technical justification for FDA submissions. Supervise Scientists in managing their projects and provide guidance in identifying problems, designing experiments and trouble shooting in an effective manner. Headed several trouble shooting team and solved formulation and process problem for commercially important products for the company.