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  • Biopharmaceutical Manufacturing
    Industry Skill Standards

    Global Biopharmaceutical Manufacturing
    Industry Skill Standards

    Click here for details on the development of Harmonized
    Biopharmaceutical Manufacuting Skill Standards


    Northeast Biomanufacturing Center and Collaborative Skill Standards
    Ten Targeted Jobs
    This is a compilation of the skills knowledge and attributes for 10 biomanufacturing jobs analyzed in this project.
  • Process Development Associate
  • Validation Specialist
  • Manufacturing Technician-Upstream
  • Manufacturing Technician-Downstream
  • Instrumentation/Calibration Technician
  • Chemistry QC Technician
  • Microbiology QC Technician
  • Environmental Health & Safety Technician
  • QA Documentation Coordinator
  • Facilities Technician
    Click here to download the Skill Standards book electronic file in Microsoft Word format.
    Published by The Northeast Biomanufacturing Center & Collaborative (NBC2), January 2005
    COMMENTS FROM BIOMANUFACTURING COMPANIES
    Centocor, County Cork, Ireland     
  • Downstream Processing (comments in red)     
  • Upstream Processing (comments in red)     
  • Proposed Technician Competencies


  • PharmaChemical Ireland National Standards
    Sterile Operator Core
    The programme consist of one theory and a minimum of 3 practical assessments which must be assessed as per the internal Assessment Procedure & the Process Implementation Procedure. The theory assessment covers Knowledge of Microbiology and applies operators involved in all aspects of Sterile Liquid Production.
    Click here to download the file in Microsoft Word format.
    Published by The Irish Pharmaceutical & Chemical Manufacturers Federation, December 2005

    QC Microbiology
    This is the assessment programme for core microbiology skills for QC personnel within the active pharmaceutical ingredient/ finished/ medical device sector.
  • Knowledge of Microbiology
  • Aseptic Technique
  • Use of Biological Safety Cabinets
  • Incubator usage
  • Streaking Out
  • Use of Microscope
    Click here to download the file in Microsoft Word format.
    Published by The Irish Pharmaceutical & Chemical Manufacturers Federation, December 2005


    Biomanufacturing In Massachusetts: An Assessment And Educational Analysis
    Prepared for:
    Massachusetts State Department of Education Division of Occupational Education

    Click here to download the Assessment & Educational Analysis in .pdf format.
    Published by Minuteman Regional Vocational Technical School District Biotechnology Task Force, June 1992


    The Model Employee: Preparation for Careers in the Biopharmaceutical Industry
    Prepared for:
    The North Carolina Biomanufacturing and Pharmaceutical Training Consortium

    Click here to download the "Model Employee" skill standards in .pdf format.
    Published by North Carolina Biomanufacturing and Pharmaceutical Training Consortium, May 2005


    Skills and Knowledge Standards for Associate Degree in Biotechnology Programs in Indiana
    Prepared for:
    Biotechology Programs at Indiana Community Colleges

    Click here to download the Indiana skill standards in .doc format.
    Created by:
    Alisa Wright, Baxter Pharmaceutical Solutions
    Gary Bormett, Dow AgroSciences LCC
    Jose Hanquier, Robert MacKay, Roberta Talmage, Eli Lilly and Company
    Wade Lange, Indiana Health Industry Forum
    Andy Cothrel, Roche Diagnostics Corp.
    June 2003



    Chemical Technical Standards
    Prepared for:
    American Chemical Society

  • Chemical Process Technician
  • Chemical Laboratory Technician
  • Pharmaceutical Manufacturing Laboratory Analyst


    Biotechnology and Biomedical Skill Standards
    Prepared by:
    Shoreline Community College, Seattle Washington

    Click here for web page download area and multiple section documents


    Gateway To The Future: Skill Standards for the Bioscience Industry
    Prepared by:
    The Education Development Center, Inc.

    Click here for web page download area and multiple section documents


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