Posts tagged: Hollister Stier Labs
Bill Simmons, a 30-year veteran in the pharmaceutical industry, has been named president of Spokane’s Jubilant HollisterStier contract manufacturing operation.
The company announced his appointment last week. He takes over from former CEO Marcelo Morales, who has left the company.
Simmons, 57, has had several management positions, including executive vice president at Mayne Pharma LTD, and general manager of Baxter International’s oncology and multisource injectable business, according to Jubilant HollisterStier.
Most recently, Simmons was managing partner at CSN USA LLC, a New Jersey-based consulting firm. It primarily worked with private equity investors considering investments with biotech firms.
In late 2013 the Federal Drug Administration sent a warning letter to Jubilant HollisterStier, saying its inspectors identified several concerns over quality control in the contract manufacturing area of the north Spokane site.
It referred in the letter to unexplained levels of impurities in some orders being filled for a pharmaceutical customer. Another concern was allegedly inadequate processes to ensure material sterility.
The federal agency continues to work with company officials to resolve those concerns. Tara Goodin, an FDA spokeswoman, said by email: “Because this is an open investigation, our policies prohibit us from discussing what has happened and what will happen specific to this facility.”
Shannon Jordan, a Jubilant HollisterStier spokeswoman, emailed the company’s position: “We have responded to the FDA and are actively working toward making continuous improvements to our site.”