Matthew Aksamit

Experience

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  IHOP

  Apr 2006 - Aug 2007

  Server

  Worked closely with customers and the staff to provide excellent customer service in the food service industry.

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  OfficeMax

  Apr 2007 - Dec 2009

  Sales Associate

  Provided office supply and electronics sales support for in store and off-site customers. Aided customers with technical support for electronics purchased in store.Managed small store logistics projects.Cooperated with management to minimize store loss and maintain proper inventory of products.

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  Staples

  Aug 2008 - Apr 2009

  Easy Tech Associate

  Provided electronics sales support for in store and off-site customers. Aided customers with technical support for electronics purchased in store.Managed small store logistics projects.Cooperated with management to minimize store loss and maintain proper inventory of products.

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  Kansas State University

  Aug 2009 - Sept 2014

  ∙ Taught laboratory sections for Introduction to Organic and Biochemistry, General Biochemistry, and graduate level Biochemistry I.∙ Responsible for instructing about twenty students per semester about laboratory theory and techniques, writing of laboratory reports and technical write-ups, and proper laboratory conduct and safety.∙ Tutored several students in preparation for homework, laboratory and lecture exams, and report write-ups.∙ Worked directly with course faculty and staff to discuss teaching strategies, prepare reagents, and organize course logistics. Show less

  • Graduate Research Assistant

    May 2012 - Sept 2014

  • Graduate Teaching Assistant

    May 2012 - Sept 2014

  • Undergraduate Research Assistant

    Aug 2010 - May 2012

  • Laboratory Preparation Technician

    Jan 2010 - Jan 2011

  • Undergraduate Teaching Assistant

    Aug 2009 - Aug 2010
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  City of Salina, Parks and Recreation

  May 2010 - Aug 2010

  Umpire

  Umpired youth baseball for City of Salina baseball leagues.Worked for several non-league affiliated tournaments.

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  Manhattan Parks and Recreation Department

  Apr 2011 - Aug 2014

  Umpire

  Umpired baseball and softball for youth baseball for City League and Wildcat League baseball.Worked for several league and non-league affiliated tournaments.

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  Kelly Services

  Sept 2014 - Jul 2015

  R&D Contract Scientist

  ∙ Contract Scientist for Hospira in the Hospira Products Division of Global Pharma R&D∙ Performed gap analysis and remediation to ensure compliance to internal SOPs and regulatory standards (FDA, USP, DEA, ICH).∙ Routinely perform cGMP testing of raw materials and excipients, drug products, stability samples, and process validations/verifications (cleaning, mix time, hold times, lyophilized product uniformity).∙ Write and review stability protocols and reports to support submission, or qualification and equivalency of components/drug substances from alternate sites or suppliers.∙ Review, check and verify other analysts’ electronic and paper lab notebooks, technical reports, protocols, and monographs.∙ Periodically led monthly team meetings in which analysts gave project updates, discussed laboratory and safety procedures, shared technical data, and gave presentations to instruct team members on new or unfamiliar techniques, systems, or processes. Compiled meeting minutes and organized information presented into a central database for ease of access.∙ Presented project updates and technical data to personnel in the R&D (up to site R&D director) and Chemical Quality (up to senior management) divisions.∙ Performed laboratory investigations for commercial products, in-house production runs, and out of specification test results.∙ Developed UPLC methods for analysis of drug assays and equipment cleanings.∙ Write scientific protocols and reports to communicate scientific data to site team members and senior management, Quality mangagement, Manufacturing Science & Technology scientists, and Hospira Australia program management and R&D team members.∙ Managed change control for implementation and IQ/OQ/PQ of new laboratory equipment. Show less

• 

  Hospira

  Jul 2015 - Sept 2015

  Associate Scientist

  ∙ Performed gap analysis and remediation to ensure compliance to internal SOPs and regulatory standards (FDA, USP, DEA, ICH).∙ Routinely perform cGMP testing of raw materials and excipients, drug products, stability samples, and process validations/verifications (cleaning, mix time, hold times, lyophilized product uniformity).∙ Write and review stability protocols and reports to support submission, or qualification and equivalency of components/drug substances from alternate sites or suppliers.∙ Review, check and verify other analysts’ electronic and paper lab notebooks, technical reports, protocols, and monographs.∙ Periodically led monthly team meetings in which analysts gave project updates, discussed laboratory and safety procedures, shared technical data, and gave presentations to instruct team members on new or unfamiliar techniques, systems, or processes. Compiled meeting minutes and organized information presented into a central database for ease of access.∙ Presented project updates and technical data to personnel in the R&D (up to site R&D director) and Chemical Quality (up to senior management) divisions.∙ Performed laboratory investigations for commercial products, in-house production runs, and out of specification test results.∙ Developed UPLC methods for analysis of drug assays and equipment cleanings.∙ Write scientific protocols and reports to communicate scientific data to site team members and senior management, Quality mangagement, Manufacturing Science & Technology scientists, and Hospira Australia program management and R&D team members.∙ Managed change control for implementation and IQ/OQ/PQ of new laboratory equipment. Show less

• 

  Pfizer

  Sept 2015 - now

  ∙ Chemist in the Bioanalytical and Aseptic Sciences Group of Global Technical Services after acquisition of Hospira by Pfizer.∙ Performed gap analysis and remediation to ensure compliance to internal SOPs and regulatory standards (FDA, USP, DEA, ICH). ∙ Routinely perform cGMP testing of raw materials and excipients, drug products, stability samples, and process validations/verifications (cleaning, mix time, hold times, lyophilized product uniformity). ∙ Write and review stability protocols and reports to support submission, or qualification and equivalency of components/drug substances from alternate sites or suppliers. ∙ Review, check and verify other analysts’ electronic and paper lab notebooks, technical reports, protocols, and monographs. ∙ Periodically led monthly team meetings in which analysts gave project updates, discussed laboratory and safety procedures, shared technical data, and gave presentations to instruct team members on new or unfamiliar techniques, systems, or processes. Compiled meeting minutes and organized information presented into a central database for ease of access. ∙ Presented project updates and technical data to personnel in the R&D (up to site R&D director) and Chemical Quality (up to senior management) divisions. ∙ Performed laboratory investigations for commercial products, in-house production runs, and out of specification test results. ∙ Developed UPLC methods for analysis of drug assays and equipment cleanings. ∙ Write scientific protocols and reports to communicate scientific data to site team members and senior management, Quality mangagement, Manufacturing Science & Technology scientists, and Hospira Australia program management and R&D team members. ∙ Managed change control for implementation and IQ/OQ/PQ of new laboratory equipment. Show less

  • Manager, Medical Devices and Combination Products

    Mar 2022 - now

  • Regulatory CMC Author/Editor

    Aug 2019 - Feb 2022

  • Associate Scientist

    Sept 2015 - Aug 2019
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  KSHSAA

  Aug 2017 - now

  Sports Official

  Football, Basketball, and Baseball Official for the State of Kansas

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  McPherson Fire District #9

  Mar 2018 - now

  Firefighter