Workers in clean room

Berkshire Sterile Manufacturing in Lee has about 180 employees and are seeking 20 more. Berkshire Sterile Manufacturing recently received funding from the Massachusetts Life Sciences Center to add 35 new jobs. 

LEE — Berkshire Sterile Manufacturing’s $20 million expansion plan got another boost recently, when it received money from the Massachusetts Life Sciences Center to create 35 jobs.

The $185,000 from the center’s Tax Incentive Program will pay for positions created because of the expansion project, which Berkshire Sterile began last year and hopes to complete by the end of 2022. The entire expansion project is expected to generate up to 75 jobs.

Workers wearing masks using equipment

Workers use a clean room at Berkshire Sterile Manufacturing in Lee. Money from the Massachusetts Life Sciences Center will pay for positions created because of an expansion project that Berkshire Sterile began last year and hopes to complete by the end of 2022. The entire expansion project is expected to generate up to 75 jobs.

“We’ve already added some of those,” said Berkshire Sterile CEO Shawn Kinney, referring to the company’s latest job hires. “We’ll be adding more through the end of next year.”

Berkshire Sterile, which produces sterile, injectable drugs for pharmaceutical and biotech companies that are currently in crucial studies for the treatment of various diseases, and which has been testing medications associated with COVID-19 since the coronavirus pandemic began affecting the U.S. economy last year, has 183 employees. The company, which consisted of only its three founders when it started six years ago, has added 23 employees in the past 10 months.

Shawn Kinney

Shawn Kinney is the CEO of Berkshire Sterile Manufacturing in Lee, which uses state-of-the-art technology to produce sterile injectable drugs for pharmaceutical and biotech companies that are engaged in clinical studies for the treatment of various diseases.

“I expect that we’ll have close to 225 to 230 employees by the end of next year,” Kinney said. “It’s kind of amazing, considering where we started in 2015, with just the three of us.”

Berkshire Sterile was one of 28 life sciences companies across the state to receive a combined $19.5 million in the center’s latest round of funding, which is intended to create 1,259 total jobs.

According to a news release, 68 percent of the job growth associated with this latest round of funding is scheduled to take place outside greater Boston, which is the hub of the state’s thriving biotech industry. But, Berkshire Sterile was the only company in Western Massachusetts to receive any of the money.

The company’s $20 million expansion project includes doubling the size of its current clean room and adding a state-of-the-art manufacturing line at the 116,000-square-foot Lee Corporate Center on Pleasant Street (Route 102), which originally was a toy warehouse.

At the annual 2020 town meeting in October, the town of Lee approved a $1.5 million tax incentive package for the project, which will allow Berkshire Sterile to receive a property tax break on its significant investment. In June 2020, Berkshire Sterile secured $16.5 million in financing from Berkshire Bank and Lee Bank for the expansion project.

Berkshire Sterile Manufacturing warehouse

Berkshire Sterile Manufacturing in Lee has built new warehouse space to hold over one million dollars worth of inventory, including vials and syringes, as a buffer against supply chain woes. 

Berkshire Sterile was given the go-ahead to start on the project by two state agencies before the tax incentive package had been approved because COVID-19 caused last year’s annual town meeting in Lee to be postponed twice.

According to Kinney, the expansion of Berkshire Sterile’s clean room has been completed, and the equipment associated with that growth is undergoing validation and qualification testing. But, the installation of the state-of-the-art new manufacturing line — it’s the first of its kind in the U.S., according to Kinney — has been delayed because COVID-19 has made it difficult for suppliers to find the right materials.

The materials needed to make the line are coming from Italy. Kinney said Berkshire Sterile representatives plan to go to Italy in mid-October to tweak and conduct further testing on the new equipment, which then will be shipped from Italy to the United States and is expected to arrive by the end of this year.

“I think that’s going to be our Christmas present,” Kinney said.

Representatives of the Italian company that is selling Berkshire Sterile the equipment are expected to arrive in the U.S. in January, to help assemble the new line.

Berkshire Sterile Manufacturing workers

Berkshire Sterile Manufacturing recently received funding from the Massachusetts Life Sciences Center to add 35 new jobs. "I expect that we'll have close to 225 to 230 employees by the end of next year," Berkshire Sterile CEO Shawn Kinney said.

“We hope to have it operational by the end of the first quarter next year, March or April,” Kinney said.

Berkshire Sterile is testing drugs to be used to combat Niemann-Pick disease, a rare, inherited ailment contracted mainly by young children that affects the body’s ability to metabolize cholesterol and lipids in cells.

The company also is continuing to test medications to fight COVID-19.

“I think everyone is beginning to realize that COVID is going to be with us forever,” Kinney said.

Tony Dobrowolski can be reached at tdobrowolski@berkshireeagle.com or

413-496-6224.