Biopharmaceutical Manufacturing (Biomanufacturing) High Growth Industry Jobs: Developing the Biomanufacturing Education & Training Infrastructure Sonia Wallman, Ph.D. DOL National Center for the Biotechnology Workforce Center of Excellence in Biomanufacturing New Hampshire Community Technical College Portsmouth, New Hampshire

BIOTECHNOLOGY INDUSTRY Three Major Areas of Industrial Biotechnology

Biomanufacturing = Key Sector of the Biotechnology Industry Biomanufacturing creates the protein (cellular and DNA) products of the biotechnology industry using living cells as factories Northeast greatest biomanufacturer in the nation There are hotbeds of biotechnology activity throughout the region=biotechnology clusters Hottest is the Cambridge River Basin; many others Need to provide education and training infrastructure to support the growth of the biomanufacturing sector of the industry, locally and in the region

Biomanufactuing Education and Training at Community Colleges, High Schools, and 4 Year Colleges Developed in response to biomanufacturing companies locating in an area: Alamance Community College in 1986 (near RTP biomanufacturers in NC); Contracosta CC in 1989 (near Chiron and Genentech in CA); Minuteman Technical High School and Middlesex Community College in 1989 (near Wyeth Biopharma in MA); New Hampshire Community Technical College in 1994 (near Lonza Biopharmaceuticals in NH; Wyeth) Designed to train technicians and professionals for the biomanufacturing sector of the biotechnology industry

Biotechnology/Biomanufacturing at New Hampshire Community Technical College Pease International Tradeport,Portsmouth NHCTC’s program started in 1994 to provide biomanufacturing technicians in response to the arrival of Celltech Biologics (now Lonza Biopharmaceuticals) NHCTC located down the street from Lonza Biopharmaceuticals on the Pease International Tradeport in Portsmouth, NH Key components of NHCTC’s Biotechnology Education and Training program are two courses that provide theoretical background and hands-on understanding of the tools, processes and regulatory structure of Industrial Biotechnology (192 hours/semester each): –Discovery Research (=Molecular Biology) –Biomanufacturing

Biopharmaceutical Manufacturing Industry Skill Standards The Northeast Biomanufacturing Collaborative (Northeast biomanufacturers, educators and organizations) developed the skill standards; published January 31, 2005 Cover the skills, knowledge and attributes required for 10 biomanufacturing jobs in process development, validation, upstream and downstream processing, instrumentation/calibration, quality control microbiology, quality control biochemistry, quality assurance, environmental health and safety, and facilities Used to provide a framework for developing current and future biomanufacturing education and training Used to catalyze the development of a biomanufacturing education and training infrastructure for the Northeast and nation

Biomanufacturing Job Description Biomanufacturing Technician-Upstream Responsible for assisting manufacturing in specific product-related operations in cell culture and growth. Operates and maintains production equipment as it relates to cell culture (i.e., cell harvests and separation operations). Also performs fermentation. Operates and maintains production equipment related to fermentation (e.g., fermenters, bioreactors, centrifuges). Weighs, measures, and checks raw materials to assure proper ingredients and quantities. Prepares media and buffer components. Maintains records to comply with regulatory requirements and assists with in-process testing.

Biomanufacturing Job Descriptions Chemistry QC Technician Performs a variety of inspections, checks, tests, and sampling procedures for the manufacturing process according to standard operating procedures (SOPs). Performs in-process inspection and documents results. Monitors critical equipment and instrumentation. Writes and updates inspection procedures and checklists as necessary. Requires knowledge of current good manufacturing practices (cGMPs). Microbiology QC Technician Performs routine microbiological testing of raw materials, in- process samples and finished formulations according to Standard Operating Procedures (SOPs). Conducts routine environmental monitoring of manufacturing areas, equipment and processes according to established procedures. Calibrates and maintains microbiology laboratory equipment. Compiles and analyzes data for documentation of test results and prepares related reports. Revises and updates SOPs as necessary.

The National Biotechnology Apprenticeship System (NBTAS) Targets High School students entering Community College Biotechnology/Biomanufacturing Associate degree programs Gives young people an early taste of their career choice Logs development of competencies throughout the biomanufacturing career path from high school to community college to industry and further education Provides a pump for the local, regional, national biomanufacturing education and training infrastructure

Pilot Apprentice at NHCTC Graduate of the Seacoast School of Technology, a regional technical high school in nearby Exeter, NH with a three year biotechnology program Freshman in NHCTC Biotechnology Associate in Science degree program, September 2004 Lonza Biopharmaceuticals registered as Biomanufacturing Apprenticeship provider, May 2005 Pilot Apprentice registered as an Apprentice, May 2005 Pilot Apprentice started Apprenticeship at Lonza, May 2005 (will complete first 500 hours by start of Senior year at NHCTC, September 2005) Graduates with A.S. in Biotechnology, May 2006 Goes back to Lonza to finish Apprenticeship, May new Apprentices to begin NHCTC Biotechnology A.S. degree program, September 2005

Demonstration of NBTAS On-Line Competency Verification System 1.Apprentice logs-in to ask high school teacher to validate competencies 2.High School teacher logs-in to validate competencies 3.As he works at Lonza, same process: Apprentice logs- in to ask industry mentor to validate competencies 4.Industry mentor logs-in to validate competencies 5.As he completes biomanufacturing courses at community college, Apprentice logs-in to ask community college biomanufacturing faculty to validate competencies 6.Community college biomanufacturing faculty validates competency 7.Could continue to validate competencies in same manner throughout further education

References stry_report_final.pdfwww.doleta.gov/BRG/Indprof/biotech_Indu stry_report_final.pdf