John Abate

John Abate Email and Phone Number

President and CEO at Clear Solutions Stability, Inc. @
John Abate's Location
San Diego, California, United States, United States
John Abate's Contact Details

John Abate personal email

n/a
About John Abate

Expert consultant with 20+ years of experience specializing in pharmaceutical stability programs and GMP laboratory and stability storage facility assessments.- Work with new and established pharmaceutical and biopharmaceutical companies to optimize firm's stability function, including aid in the installation, validation, configuration and management of electronic stability data managements systems (e.g. iStability LIMS, Nova-Stability), GMP SOPs, and installation and validation of stability storage units.- Assess internal and external facilities to ensure laboratory testing and processes associated with stability storage, sample handling, and data reporting processes are efficient and fully compliant with cGMP regulations and industry best practices.

John Abate's Current Company Details
Clear Solutions Stability, Inc.

Clear Solutions Stability, Inc.

President and CEO at Clear Solutions Stability, Inc.
John Abate Work Experience Details
  • Clear Solutions Stability, Inc.
    President And Ceo
    Clear Solutions Stability, Inc. Dec 2020 - Present
    San Diego, California, United States
  • Clear Solutions Stability
    Company Owner
    Clear Solutions Stability Mar 2019 - Dec 2020
    San Diego, California
    Provides pharmaceutical and biopharmaceutical companies with clear solutions for modernizing GMP stability programs, including validating and implementing electronic-based stability data management systems (e.g., iStability) and stability sample storage units, authoring related SOPs, and staff training.
  • Pfenex Inc
    Principal Consultant
    Pfenex Inc Apr 2016 - May 2019
    San Diego, Ca
    Managed all activities associated with company's transition to an electronic stability data management system. Authored all SOPs related to the internal and external activities associated with the company's stability program. Oversaw the daily management of stability studies conducted at contract test sites.
  • Bristol-Myers Sqibb / Astrazeneca
    Biopharmaceutical Development Team Management
    Bristol-Myers Sqibb / Astrazeneca Sep 2012 - Feb 2014
    La Jolla, Ca
    View
  • Amylin Pharmaceuticals, Llc
    Assoc. Director, R&D Operations
    Amylin Pharmaceuticals, Llc Jan 2008 - Sep 2012
    La Jolla, Ca
    Lead PM for late-phase development combination product and CMC PM for two Ph2/Ph3 development combination products.
    View
  • Amgen, Thousand Oaks, Ca
    Principal Product Quality Leader
    Amgen, Thousand Oaks, Ca 1997 - 2007
    Led the Product Quality Teams for several small and large molecule programs from Phase 1 to market approval.
    View
  • Alpharma, Baltimore, Md
    Analytical R&D Manager
    Alpharma, Baltimore, Md 1995 - 1997
    Alpharma USPD was the US's largest manufacturer of prescription liquid drug products. The US division was acquired by Actavis in 2005.Supervised 5 R&D chemists responsible for performing stability testing of several development products, including solutions, suspensions, topicals, and nasal inhalers.
  • Ben Venue Labs, Bedford, Oh
    Stability Supervisor
    Ben Venue Labs, Bedford, Oh 1990 - 1995
    Supervised up to 7 chemists responsible for performing stability testing of several development and marketed parenteral pharmaceuticals.

John Abate Skills

Biopharmaceuticals Biotechnology Gmp Commercialization Pharmaceutical Industry Ind Fda Technology Transfer Validation Glp Regulatory Submissions Project Management Drug Development R&d Cmc Medical Devices Hplc Analytical Chemistry Quality System Sop Biochemistry Purification Monoclonal Antibodies Lims Sds Page Ms Project Combination Products Small Molecules Peptides Process Simulation Online Communications Cgmp Quality Systems Process Development Pharmaceuticals Process Validation Stability Studies Protein Production Stability Programs Stability Operations Biosimilars Recombinant Dna Bioanalysis Standard Operating Procedure Good Laboratory Practice U.s. Food And Drug Administration Laboratory Information Management System

John Abate Education Details

Frequently Asked Questions about John Abate

What company does John Abate work for?

John Abate works for Clear Solutions Stability, Inc.

What is John Abate's role at the current company?

John Abate's current role is President and CEO at Clear Solutions Stability, Inc..

What is John Abate's email address?

John Abate's email address is jo****@****lin.com

What schools did John Abate attend?

John Abate attended The Johns Hopkins University, Miami University.

What skills is John Abate known for?

John Abate has skills like Biopharmaceuticals, Biotechnology, Gmp, Commercialization, Pharmaceutical Industry, Ind, Fda, Technology Transfer, Validation, Glp, Regulatory Submissions, Project Management.

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