Stephen Andruski

Experience

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  Sigma Aldrich

  Jan 1980 - Aug 1982

  Research Chemist

  Reseach Chemist in Production and R&D Departments

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  University of Kansas

  Mar 1987 - Jan 1989

  Post-doctoral Researcher
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  FMC

  Feb 1989 - Jan 1998

  Research Scientist

  PhD Research Scientist in the Process R&D Department.

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  AMRI

  Jun 1998 - Apr 2010

  Senior Research Scientist II

  Experience in designing suitable routes for the scale up of intermediates in support of customer projects. Verification and optimization of processes for pharmaceutical APIs prior to their use in cGMP campaigns. Development and validation of a variety of analytical methods in support of GMP production. Supervisory and project management responsibilities.

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  U.S. Pharmacopeia

  Apr 2010 - Dec 2023

  Manages the scheduling and implementation of activities related to cGMP site audits; CMC documentation reviews; and product sample testing for conformance to specifications for the USP Verification Programs Department. Serves as the primary contact for participating companies in the Pharmaceutical Ingredient Verification Programs and manages the verification process for those companies. Assists in the preparation and/or evaluation of cGMP site audit reports, CMC observation reports and test result reports regarding facilities and products undergoing verification. Show less Manages the scheduling and implementation of activities related to cGMP site audits; CMC documentation reviews; and product sample testing for conformance to specifications for the USP Verification Programs Department. Serves as the primary contact for participating companies in the Pharmaceutical Ingredient Verification Programs and manages the verification process for those companies. Assists in the preparation and/or evaluation of cGMP site audit reports, CMC observation reports and test result reports regarding facilities and products undergoing verification. Show less

  • Senior Manager, Verification Programs

    Jan 2018 - Dec 2023

  • Manager, Verification Programs

    Apr 2010 - Jan 2018
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  ROCKVILLE BIKE HUB

  Sept 2014 - now

  President of the Board

  The Rockville Bike Hub, a nonprofit community bike shop, aims to enable members of the community to obtain, recycle and maintain bicycles, to repair and donate to the needy unused and unwanted bicycles, to educate community members about benefits of biking and to enhance the health of our community and environment by promoting bicycle transportation.

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  Blind Badger GMP Consulting

  Mar 2024 - now

  Owner