Working in biomanufacturing puts you at the center of an industry that uses cells of living organisms to produce insulin, vaccines, and life-saving pharmaceuticals. This includes treatment for anemia, blood clots and cancer. Although biomanufacturing companies employ scientists with advanced degrees for research, they also rely on technicians with two-year degrees and engineers and management staff with four-year degrees. Biomanufacturers need a skilled workforce and often underwrite education expenses for employees interested in advancing their careers.
Manufacturing or Process Technician
According to the North Carolina Biotechnology Center, the bulk of jobs in biomanufacturing are in production. Upstream manufacturing technicians work on cell culture and cell growth, from harvesting cells to fermentation. This includes measuring and mixing the reagents and chemicals used to synthesize drugs. Downstream manufacturing technicians handle various cleaning and filtration steps and other processing operations. They also may run the packaging and labeling equipment. Both must keep accurate records for regulatory compliance. An associate's degree suffices to qualify as a manufacturing technician. Experience on the production side of the business, combined with a bachelor's degree, can lead to advancement to quality control.
A validation specialist ensures that all equipment, software programs, utilities and manufacturing processes conform to standards, regulations and specifications. This work entails developing the protocols, or procedures, used for validation and writing reports of the findings. According to a Massachusetts Biotechnology Council survey, this position requires a bachelor's degree in a technical, engineering or scientific field related to biotechnology and at least three years of work experience in a regulatory environment.
Quality Control, or QC Technicians
While validation specialists concentrate on the "hard" side of production, quality control, quality assurance, microbiology and chemistry technicians test finished products, in-process samples and raw materials. These analysts usually hold a degree in biology, chemistry, biochemistry, chemistry, microbiology or biology, although some employers accept entry-level candidates with two-year degrees in a biotechnology or laboratory discipline. Working in quality control requires an understanding of company procedures and federal regulations. When test results stray from accepted standards, quality assurance technicians conduct investigations to learn why and oversee corrective action.
The design of biomanufacturing processes and the installation and technological upgrades of equipment used to make ointments, capsules and liquid forms of drugs fall under the responsibility of process engineers. A four-year degree is required. They develop procedures to test product condition during every stage of production. They may be consulted to help troubleshoot equipment malfunctions. Process engineers deal with personnel throughout the company, as well as regulatory agencies, investors and customers. They need strong project management and communication skills.
Shared Skills and Attributes
In its model employee report, the North Carolina Biomanufacturing and Pharmaceutical Training Consortium outlined the attributes and skills needed to succeed in this highly regulated industry. Personal responsibility and accountability sit at the top of this list, along with being self-motivated, having a continuous desire to learn and respecting good manufacturing practices, or GMP: cleanliness, documentation, equipment verification and quality control procedures. Sought-after skills include the ability to work independently and with a team, attention to detail and excellent communication skills, both written and oral.
- Amgen: Biologics and Biosimilars: An Overview
- Laney College: Biomanufacturing Home
- North Carolina Association for Biomedical Research: Exploring Careers in Biomanufacturing
- North Carolina Biotechnology Center: Window on the Workplace 2012
- Bio-Link: The Survey Group's Biotechnology Compensation Survey in Partnership with the Massachusetts Biotechnology Council
- North Carolina Biotechnology Center: Bioscience Careers: Quality Assurance Associate
- Northeast Biomanufacturing Center and Collaborative: 10 Targeted Biomanufacturing Job Descriptions
- Mount Wachusett Community College: Biotechnology Programs
- North Carolina Association for Biomedical Research: Bioscience Careers: Process Engineer
- The North Carolina Biomanufacturing and Pharmaceutical Training Consortium: The Model Employee
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