Stanton Springs’ pharmaceutical plant is hopeful it will receive its approval from the U.S. Food and Drug Administration in 2018 for its new plasma manufacturing facility in Social Circle.
Shire, the global biotechnology leader in rare diseases, announced its first submission to the FDA in 2017.
“FDA approval is needed to sell any product manufactured at our site, which is our ultimate goal – to provide therapies for our patients,” Gabe Khouli, communication lead for the Georgia facility, said. “At Shire, our mission is to be champions for people around the world who are struggling with rare diseases.”
Khouli said the FDA application is just the first step for the company.
“Receiving approval for our immunoglobulin therapy would mark the culmination of six years of work since the project was first announced in 2012,” he said. “We will file a separate submission to the FDA later this year for our albumin therapy.”
As the approval process continues, employment opportunities will continue to open up.
“As we seek approval, we are continuing to ramp up our operations and expect to hire more 100 employees this year, with a similar amount of hiring in 2019,” Khouli said. “We are hiring in a variety of areas, with the bulk of hiring for positions in manufacturing, warehouse and our quality control laboratory, as well as positions in engineering, process equipment maintenance, utilities operations, quality assurance, IT and other areas. All jobs can also be viewed at shire.com/careers, and applicants can filter by location.”
The Social Circle location will add around 30 percent to the capacity of Shire’s internal network once fully ramped up, Khouli said.
“Shire is seeing substantial growth across its Immunology portfolio and plans to continue adding capacity for those products,” he said.
Khouli said Shire will continue to involve the community going forward.
“We are also planning to seek even more opportunities to engage with our local communities, including strengthening partnerships with local school systems, colleges, nonprofits and civic organizations,” he said. “In 2017 alone, we participated in 21 outreach events, including a variety of area nonprofits, schools and other organizations. We’ve already participated in several events in 2018 as well. Many of the events were organized by our employee-led Business Resource Groups, who not only focus on community outreach, but also sponsor numerous internal events focused on professional development and networking.”