Texas Skill Standards Board

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TSSB Recognizes Revised Biotechnology and Biomedical Skill Standards

October, 2009 - On October 20, 2009, the Texas Skill Standards Board recognized revised Biotechnology and Biomedical skill standards. The skill standards were developed by Shoreline Community College in Shoreline, WA, and originally recognized by the TSSB at its July 13, 2004 meeting. In 2007, Shoreline Community College conducted an extensive review of the skill standards and published a revised set in 2008.

The revised skill standards are comprised of two areas of concentration for entry-level technicians: 1) Regulatory Affairs and Clinical Trials; and 2) Research and Development.

The changes to the regulatory affairs and clinical trials concentration skill standards are limited to the addition of information technology-related activities such as data management, system and application administration, and coding of data

Technicians working in the areas of regulatory affairs and clinical trials make sure that the company’s work meets regulatory requirements. They gather information and assemble regulatory submissions, assist with annual reports, implement clinical studies, review data from clinical trials, review labeling and advertising materials for compliance with regulations and guidelines, prepare reports, coordinate data collection, and other functions.

The major change to the previously recognized research, development, and manufacturing concentration skill standards is the removal of manufacturing-related activities, focusing the skill definitions on research and development alone. While manufacturing is an important element in the biomedical and bioscience industry in Texas, its removal from the skill standards is in line with the current industry environment. The Texas Life Sciences Industry Profile of 2009 publication indicates that manufacturing will experience only moderate job growth in the state in the foreseeable future, and it can be assumed that only a portion of that moderate growth would include two-year degree level jobs.

Technicians in the areas of research and development work in laboratories and hospitals, performing routine laboratory work, maintaining and performing preventive maintenance on research equipment, assisting with research and development, and meeting documentation requirements.

Texas Healthcare and Bioscience Institute (THBI) representatives reviewed the revised skill standards and recommend their promotion and use in Texas. THBI President Thomas Kowalski has written a letter of endorsement of the skill standards on behalf of the Institute, which is composed of biotechnology, medical device, and pharmaceutical companies as well as universities and private research institutions, recommending that the TSSB recognize the updated skill standards.

The TSSB recognized the skill standards in accordance with its Guidelines for the Development, Recognition, and Usage of Skill Standards (October 2006). For more information, please contact the TSSB at (512) 936-8100.