When hiring into quality roles, Portola, too, prefers to hire candidates with chemistry backgrounds, Pandey says. “Chemists are already trained in attention to detail, critical thinking, and problem solving—attributes that are important in QC. In addition, chemists are trained in doing analysis through high-performance liquid chromatography, mass spectrometry, and nuclear magnetic resonance, which helps in the characterization of a drug product.” Medicinal and organic chemists, many of whom are still unemployed after the last wave of industry cutbacks, could transition into QC and QA roles, Pandey says. They may have an edge in identifying and characterizing process impurities and degradants and understanding how they were formed or generated during the manufacturing process.
Whether they come from a medicinal or organic chemistry background, scientists don’t need to have a Ph.D. to work in the quality arena at Portola, Pandey says. Scientists from a variety of backgrounds and all degree levels currently work in QC and QA at most pharma and biotech firms. At Genentech, for example, “many in our group have Ph.D. degrees, but several have bachelor’s degrees with industry experience,” Smith says. Those in the QPS role come from a broad range of backgrounds in QC testing, analytical development and validation, QA, or process development, he adds.
Lilly is among those companies that hire freshly minted B.S. chemists into their quality management ranks. In fact, Vargas encourages new pharma-oriented chemists to start their careers working in a QC lab, “which allows them to get hands-on experience with state-of-the-art instrumentation and develop a good understanding of the GMP world.” However, landing that first job on a quality team can be difficult for some new B.S. graduates. To gain an edge, Ash Stevens’ Munk advises young chemists to gain some experience doing undergraduate research either in an internship or within an academic laboratory. “Nothing does more to excite me about a young candidate than knowing that they have already conducted some kind of chemistry research, especially in organic synthesis,” he says. “If you are synthesizing molecules, you have to use instrumentation to look at purity, which helps you to develop techniques that are important to a QC bench chemist,” he says. To help fledgling chemists gain this kind of experience, Ash Stevens hires a couple of interns each summer, he says.It's interesting to note that companies would like you to have educated yourself on GMP issues ("It’s now possible to do online searches and take courses to learn about FDA guidelines for characterizing a drug substance at different stages of clinical development, for example,” she says.") Other desirable traits include having taken business or engineering classes, having worked in multi-disciplinary teams and demonstrating the ability to work quickly and in a relatively high-pressure environment.
One of the last statements in the article is heartening:
“I like that I get to test products to be sure that they are free of impurities, have the right amount of active ingredients, and will dissolve in the time that we say that they will,” she says. “I like that as a QC pharmaceutical chemist, I am helping people get the medicine they need to feel better. I feel I am making a difference in the world.”Nice to see.