Vito LaVopa, Ph.D.
Head - Drug Substance, Technical Operations at Rhythm Pharmaceuticals Inc.- Claim this Profile
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Bio
Credentials
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Project Management Foundations: Requirements
LinkedInJul, 2020- Nov, 2024
Experience
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Rhythm Pharmaceuticals Inc.
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United States
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Biotechnology Research
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100 - 200 Employee
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Head - Drug Substance, Technical Operations
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Dec 2020 - Present
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US Tech Solutions
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United States
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IT Services and IT Consulting
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700 & Above Employee
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Contract Position- Process Sciences-Drug Product
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Oct 2020 - Dec 2020
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Melinta Therapeutics
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United States
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Biotechnology Research
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100 - 200 Employee
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Sr. Director, CMC Drug Substance Development & Technical Operations
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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.
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The Medicines Company
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United States
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Sr. Director, Drug Substance Development
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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)
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Director, API Development
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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
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Sr. Manager
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Sep 2006 - Feb 2011
Assisted drug product lead on successful technology transfer to CMO of an injectable product within a tight 6 month timeline.
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PLIVA
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Pharmaceutical Manufacturing
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700 & Above Employee
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Manager
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Jul 2001 - Aug 2006
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Watson Laboratories
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Danbury, CT
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Manager
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Jan 2000 - Jun 2001
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Bayer
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Chemical Manufacturing
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700 & Above Employee
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Specialist (Bayer Diagnostics)
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Apr 1996 - Dec 1999
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Merck
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Procurement Analyst (Technical Supplier Development)
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Mar 1992 - Mar 1996
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Sr. Chemical Engineer
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Dec 1989 - Mar 1992
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Associate Sr. Chemical Engineer
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Dec 1987 - Dec 1989
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Education
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Massachusetts Institute of Technology
Sc.D./MSCEP, Chemical Engineering -
Rutgers Graduate Business School
MBA, Finance concentration -
Tufts University
BSChe, Chemical Engineering