Harmonized Biopharmaceutical Manufacturing Skill Standards

The information below and on linking pages details the development of the Harmonized Biopharmaceutical Manufacturing Skill Standards. The majority of these efforts took place at a joint industry/education meeting in Indianapolis, September 24-27, 2007. An article summarizing the meeting can be found by clicking here.

Photo courtesy of Ivy Tech Community College

Skill Standards Meeting Table of Contents

Northeast Biomanufacturing Center and Collaborative Skill Standards
The standards for ten targeted biopharmaceutical manufacturing jobs were developed by Northeast biomanufacturers in 2003/2004 and published in January 2005. This is a compilation of the skills, knowledge and attributes for the ten biomanufacturing jobs:

  • 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.

Biotechnology/Biomedical Skill Standards
A compilation of the skills standards produced by Shoreline Community College in Seattle, Washington in 2007.
Click here for 5 meg .pdf file.

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

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