Nicolas Alexander

Experience

• 

  Grafton-Midview Public Library

  Aug 2002 - Nov 2009

  Worked as customer service representative to patrons of the library. Performed research on various topics for patrons. Assisted in technical support when needed. Assisted in maintaining library grounds and shelving of library materials.

  • Library Associate

    Jan 2006 - Nov 2009

  • Library Page

    Aug 2002 - Dec 2005
• 

  Model Elementary School

  Aug 2006 - May 2009

  Elementary Tutor

  Assisted third grade teachers with their classrooms. Worked with groups of students to help them become proficient in their schooling.

• 

  ChanTest

  Nov 2009 - Mar 2011

  Staff Scientist

  Performed biological and chemical pre-clinical testing within a GLP environment. Oversaw safety program and provided safety training to new employees.

• 

  Boehringer Ingelheim

  Mar 2011 - Dec 2013

  Provided comprehensive safety services for one of the manufacturing facilities as well as quality and development laboratories. Performed industrial hygiene monitoring and analyzed new products for safety and toxicological concerns. Set up and formulated drug products in a cGMP environment. Participated in the safety team to provide a safer work environment.

  • Environmental Health & Safety Specialist

    Mar 2012 - Dec 2013

  • Formulations Chemist

    Mar 2011 - Mar 2012
• 

  The University of Akron

  Jan 2014 - Jan 2018

  Research assistant focusing on multidimensional mass spectrometry of amphiphilic systems as well as maintenance of the mass spectrometry laboratory. Teaching assistant for undergraduate chemistry laboratories.

  • Graduate Research Assistant

    Jan 2017 - Jan 2018

  • Graduate Teaching Assistant

    Jan 2014 - Dec 2016
• 

  Catalent Pharma Solutions

  Jan 2018 - Jan 2021

  • Improved customer relations by functioning as the analytical interface for new and existing clients• Provided troubleshooting experience and method development knowledge to new methods• Reviewed and approved protocols for method development and transfers to ensure they were meeting current ICH and USP guidelines• Managed investigations for method protocol failures and implementation of method modifications to prevent reoccurrence of failures• Managed and provided performance management for 10 scientists Show less

  • Quality Control Manager

    Jul 2020 - Jan 2021

  • New Product Initiation Supervisor

    Oct 2019 - Jul 2020

  • Quality Control Supervisor

    Jul 2018 - Oct 2019

  • Analytical Scientist

    Jan 2018 - Jul 2018
• 

  Battelle

  Jan 2021 - Dec 2023

  Senior Quality Assurance Specialist

  - Performed internal facility inspections for compliance with EPA, US Army, OSHA, CDC, and KDEP requirements for chemical weapon destruction.- Performing analysis of laboratory non-conformance and performance trends.- Developed metrics and trends to evaluate laboratory performance on an individual operator level as well as a holistic level.

• 

  Cyrus Scientific

  Aug 2021 - Dec 2023

  Director of Analytical Chemistry

  ▪ Designed 1500 sq ft lab from the ground up and developed laboratory procedures in compliancewith GLP practices▪ Lead a team responsible for the development and validation of analytical methods in compliance with ICH and USP▪ Managed external relationships with CMOs and other analytical service providers.▪ Provided analytical and quality leadership and support for clients CMC needs▪ Designed and led audits to support client compliance with FDA, USDA, and ISO regulations

• 

  Regeneron

  Dec 2023 - now

  Associate Manager QA Investigations