James Polke

Senior Manufacturing Engineer at 3DBio Therapeutics
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Contact Information
us****@****om
(386) 825-5501
Languages
  • English Native or bilingual proficiency
  • German Professional working proficiency

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Bio

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Experience

    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Senior Manufacturing Engineer
      • Aug 2022 - Present

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Engineering Manager
      • Oct 2017 - Aug 2022

      Part of a team responsible for the specification, purchase, installation, qualification and maintenance of production equipment, utilities and supporting facilities across six buildings. Individually responsible for planning and executing multiple capital projects with expenditures from $10k - $1mil. Communicated expectations and timelines to upper management, quality teams and relevant business units. Part of team that worked on larger multi-million dollar capital improvement projects. Mentored co-ops students, interns and junior engineers. Direct manager of 1 junior qualification engineer. Responsible for planning, implementing, qualifying and managing changes to computer systems to comply with electronic records and 21 cfr part 11 requirements. Responsible for writing technical documents including qualification protocols, SOPs, work instructions and other documents. Optimized processes in order to limit manual intervention and reduce production time.

    • United States
    • Advertising Services
    • 1 - 100 Employee
    • Project Coordinator
      • Aug 2016 - Oct 2017

    • Junior Project Manager
      • Nov 2015 - Aug 2016

    • Lab Assistant
      • Sep 2014 - May 2015

      Assisted in running the Introduction to Physics Labs for pre-medical track students. Setup equipment, troubleshot and repaired malfunctions, and assisted students with the procedures. Assisted in running the Introduction to Physics Labs for pre-medical track students. Setup equipment, troubleshot and repaired malfunctions, and assisted students with the procedures.

    • United Kingdom
    • Manufacturing
    • 700 & Above Employee
    • Intern
      • May 2014 - Aug 2014

      Assisted the technical and quality teams with several projects including ISO 9001 implementation, harmonization of American innovations with the German pipeline and optimization of quality data reporting and tracking. Assisted the technical and quality teams with several projects including ISO 9001 implementation, harmonization of American innovations with the German pipeline and optimization of quality data reporting and tracking.

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Intern
      • May 2013 - Aug 2013

      Worked with plant managers to create efficiency data and used Excel and JDE to sort, tabulate, and analyze that data to improve budgets. Also assisted in the design, sourcing and testing of several new primary and secondary packages. Worked with plant managers to create efficiency data and used Excel and JDE to sort, tabulate, and analyze that data to improve budgets. Also assisted in the design, sourcing and testing of several new primary and secondary packages.

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Intern
      • May 2012 - Aug 2012

      Worked with plant managers to create efficiency data and used Excel and JDE to sort, tabulate, and analyze that data to improve budgets. Also assisted in the design, sourcing and testing of several new primary and secondary packages. Worked with plant managers to create efficiency data and used Excel and JDE to sort, tabulate, and analyze that data to improve budgets. Also assisted in the design, sourcing and testing of several new primary and secondary packages.

    • United States
    • Research Services
    • 700 & Above Employee
    • Assistant
      • Jun 2011 - Aug 2011

      Assisted in preparing experiments, culturing bacteria, and cleaning equipment. Assisted in preparing experiments, culturing bacteria, and cleaning equipment.

Education

  • University at Buffalo
    Master of Engineering - MEng, Industrial Engineering (Engineering Management)
    2020 - 2023
  • Fordham University
    Bachelor of Science (BS), Engineering Physics, German
    2011 - 2015
  • Regis High School
    2007 - 2011

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