Vito LaVopa, Ph.D.

Head - Drug Substance, Technical Operations at Rhythm Pharmaceuticals Inc.
  • Claim this Profile
Contact Information
us****@****om
(386) 825-5501
Location
New York City Metropolitan Area

Topline Score

Topline score feature will be out soon.

Bio

Generated by
Topline AI

You need to have a working account to view this content.
You need to have a working account to view this content.

Credentials

  • Project Management Foundations: Requirements
    LinkedIn
    Jul, 2020
    - Nov, 2024

Experience

    • United States
    • Biotechnology Research
    • 100 - 200 Employee
    • Head - Drug Substance, Technical Operations
      • Dec 2020 - Present

    • United States
    • IT Services and IT Consulting
    • 700 & Above Employee
    • Contract Position- Process Sciences-Drug Product
      • Oct 2020 - Dec 2020

    • United States
    • Biotechnology Research
    • 100 - 200 Employee
    • Sr. Director, CMC Drug Substance Development & Technical Operations
      • Jan 2018 - Feb 2020

      Provide technical and regulatory support for 4 antibiotic drug substances with 2 in the launch phase. Manage contract manufacturers and interact with technical and regulatory staff at marketing partners to address regulatory questions. Provide technical and regulatory support for 4 antibiotic drug substances with 2 in the launch phase. Manage contract manufacturers and interact with technical and regulatory staff at marketing partners to address regulatory questions.

    • United States
    • Pharmaceutical Manufacturing
    • 200 - 300 Employee
    • Sr. Director, Drug Substance Development
      • Mar 2016 - Jan 2018

      Led CMC development at contract manufacturers through clinical phase and commercial launch. Involved with all aspects of drug substance development including analytical and process validation, scale-up, capacity planning, supplier management and regulatory submissions. • Led CMC development through scale-up, validation and successful FDA and EMA approval for a nucleotide API (cardiovascular drug - cangrelor)

    • Director, API Development
      • Mar 2011 - Mar 2016

      -Led project which successfully achieved global approval of a new supplier and new process (solid phase vs liquid phase synthesis) of a commercial product (cardiovascular - bivalirudin - peptide)-Led drug substance tech-transfer and development activities for a biological (protein) in Phase 2 (Apo-A1 Milano) for 18 months

    • Sr. Manager
      • Sep 2006 - Feb 2011

      Assisted drug product lead on successful technology transfer to CMO of an injectable product within a tight 6 month timeline.

    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Manager
      • Jul 2001 - Aug 2006

    • Manager
      • Jan 2000 - Jun 2001

    • Chemical Manufacturing
    • 700 & Above Employee
    • Specialist (Bayer Diagnostics)
      • Apr 1996 - Dec 1999

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Procurement Analyst (Technical Supplier Development)
      • Mar 1992 - Mar 1996

    • Sr. Chemical Engineer
      • Dec 1989 - Mar 1992

    • Associate Sr. Chemical Engineer
      • Dec 1987 - Dec 1989

Education

  • Massachusetts Institute of Technology
    Sc.D./MSCEP, Chemical Engineering
    1983 - 1987
  • Rutgers Graduate Business School
    MBA, Finance concentration
    1992 - 1996
  • Tufts University
    BSChe, Chemical Engineering
    1979 - 1983

Community

You need to have a working account to view this content. Click here to join now