[Fred J.] Fleitz is a synthetic organic chemist who earned a Ph.D. at Stanford University under Barry Trost. After graduating in 1996, Fleitz joined Merck & Co.’s process research group in Rahway, N.J., where he was schooled in industrial process chemistry by some of the most experienced chemists in the business. Joining Merck in what were still the drug industry’s golden years, Fleitz expected to spend most of his career there. But the realities of patent expirations and Wall Street expectations soon intruded. Merck acquired Schering-Plough in 2009. In the summer of 2010, Fleitz, like many Merck scientists, was let go.
During his search for a new job, Fleitz learned about Cambridge Major Laboratories, a pharmaceutical chemical company in Germantown, Wis. While Merck and other big pharma companies were downsizing, Cambridge Major was expanding. It was looking for experienced chemists with the ability to shepherd projects through a new large-scale manufacturing facility. Michael W. Major, the company’s founder, offered Fleitz a job as senior manager for process R&D.Dr. Fleitz's new employer won a contract with Walter Piskorski of Euthymics, a company that's looking to launch an antidepressant drug, amitifadine. The rest of the article is a nice story about a successful plant scale-up:
Digging into the job early last year, Fleitz and his team had the luxury of an existing synthetic route. The earliest medicinal chemistry synthesis of amitifadine was a multistep process that required a separation of enantiomers at the end. But a team of Merck chemists—coincidentally, colleagues of Fleitz’s when he worked there—had developed an elegant asymmetric synthesis during the period that Merck had the compound (Org. Lett., DOI: 10.1021/ol061650w).
In the Merck synthesis, the first reaction step determines enantiomeric excess, so a key goal for Fleitz and his colleagues was to find the right temperature and other conditions to minimize loss of that excess in subsequent reaction steps. They also needed to re-create specifications that Merck may have established but that weren’t in the literature.At the same time, the Cambridge Major chemists were scaling up the process from the glassware synthesis completed by Merck into one that would work in small stainless steel reactors for clinical-trial quantities and then in larger reactors to yield the hundreds, if not thousands, of kilograms that would be needed for commercialization.
It’s a task that Cambridge Major is well suited for, according to Fleitz. “We have that ability within the same facility, so the chemist that started the project can follow it all the way through,” he says.Nothing quite like a process chemistry story with a happy ending.