This video produced for Teachers' Domain profiles Kim, a quality control microbiologist at the biopharmaceutical corporation Bristol-Myers Squibb. Her company makes a range of medicines to treat many diseases, and it's Kim's responsibility to make sure the products she works with are safe and effective before they reach patients. For example, she tests the purity of as many as 100 water samples each day because water is one of the main ingredients in drugs. Kim explains the importance of quality control in drug manufacturing, and how new biotechnology tools help her do her job.
Biomanufacturing refers to the manufacture of products using living cells. Perhaps the best-known applications of biomanufactured products are drugs for human consumption, also known as biopharmaceuticals. As is true of the traditional pharmaceuticals sector, the biopharmaceuticals sector is highly regulated. Thus, complying with federally recommended standards is essential.
Setting safety and precision standards, and testing to ensure these standards are met, are the core functions of a company's quality assurance (QA) and quality control (QC) departments. While QA is a preventive procedure implemented to prevent potentially costly and deadly product defects, QC is a corrective procedure. It allows laboratory workers to identify production defects and to correct them before products are released into the market.
Kim, the subject of this video, works as a quality control microbiologist. She is responsible for testing raw materials for purity and potency before they are processed. This includes water, a main ingredient in certain drug products. Kim also tests products as they come out of production. The QC microbiologist can identify problems so that the manufacturer is not sidetracked by unnecessary (and time-consuming) investigations and product recalls. These can damage the manufacturer's reputation as well as its bottom line. But even more important, according to Kim, the QC microbiologist's role is to ensure that patients are not harmed by the products they ingest.
Chemistry, biochemistry, biology, and microbiology degrees are commonly required for positions in QC. Job candidates must demonstrate precision in their previous work or training. But education and experience are not all that matters. Hiring managers also look for people who are inquisitive by nature, always questioning why something happened the way it did. Biomanufacturers typically encourage continuing education for employees, especially in areas of safety training and technological advances. This was true with Kim, who went back to school to get her master's degree after she began working in the field. She acknowledges that furthering her education has helped advance her career. She is presently in a supervisory role and hopes one day to be in a director-level position.
Here's how Kim describes what interests her about her work, why she views it as highly important, and what career options exist within the QC field:
I enjoy the science.... Keeping current on [new] technologies is very stimulating and exciting as well. Also, we work in a regulated industry. Those regulations are constantly changing, so there is always a sense of education and learning with this job, which is exciting.
My job here is to ensure that the product, water, and environment are all clean and safe. We test those to make sure that the final product—the medicine going out the door—is safe and effective for patients to use.... Sometimes you hear about a product recall. Well, I'm here to make sure that doesn't happen.
I fell into quality control microbiology, but there's quality control analytical, there's training, there's quality engineering, there's the whole manufacturing process. There are so many different aspects of [quality control], and a lot of people go from one area to the other area to help contribute. So the field is very exciting.
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