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Exclusive Life Science Feature feel comfortable approving a new manufacturing process. When one of the keys to the project's success was effective project doing something new, Ciambrone advises working with regulators governance. "The owners of the project were the decision makproactively. "We met with the FDA and EMA (European Medicines ers," he affirms. "We didn't spend weeks and months languishAgency) in the middle of designing the plant," he relates. "Some ing for decisions." Ciambrone admits this may be the benefit of the feedback we of being at a fairly received was expected, small company. But such as challenging does it have to be? us to make sure we Leadership governs had the right protobest when it governs "What's the best advice I have ever received? Don't try cols in place for leechleast. Ciambrone subto be someone else," says Bill Ciambrone, EVP of globables, extractables , scribes to removing as al technical operations at Shire. During the first nine and other necessary many layers of bureauyears of his career, he held a number of lower-level controls." According cracy as possible. "You leadership positions. Feeling he wasn't a good leader, to Ciambrone, because cannot have a process he decided to get out of leadership, seeking roles as the company already by which things have an individual contributor. When a mentor asked why had been using the to go through 15 levhe was looking to leave leadership, Ciambrone was the same material for storels in the organization benefactor of the best leadership advice he had ever age and buffer, the before they get blessed Bill Ciambrone, EVP of global technical operations, Shire received. "The reason you do not like it and are strugteam felt confident by someone at the gling with leadership is you are trying to be a leader about the protocols in top," he explains. "It that is not you," he recounts being told. According to place. What surprised has got to be quick. Ciambrone, if you want to be a great leader, you need to be yourself and not try to be like someone Ciambrone, however, If you are asking the else. The message was to be more natural and genuine. "Authenticity is a great leadership characwas feedback from the team to move really teristic," he states. "I have never seen a fake leader maintain authenticity. You have to be leading EMA. "They loved the fast, you need to supnaturally and not everyone does this the same way." In addition to trying to stay true to his natural idea," he says. "They port the team with leadership style, Ciambrone takes care not to take himself too seriously. "Take your job seriously, thought we were actuquick decision makbut not yourself," he says. "Your title does not make you special. The job is special, not you." ally doing what should ing." Ciambrone sugalways have been done gests if you are managin terms of contamiing a similar project, nation control. They liked the idea of getting rid of sterilization put in place effective governance, with an empowered team and and validation and using disposable technology to prevent crossready access to decision makers. contamination and carry over." Ciambrone admits that working Since the completion of Project Atlas in 2010, which came in five with regulators was the biggest challenge behind designing the months ahead of schedule and $10 million under budget, product plant and helping the providers of the reactor to develop their sales revenues for Shire have grown by $1.2 billion. The gamble prototype into a commercial product. "We needed to demonstrate seems to have paid off. For example, the SUS design resulted in a to the FDA that what we were planning not only made sense, but 38 percent reduction in total facility size and approximately a $50 also that we were able to communicate the technology and due million reduction in initial capital costs. In addition, the facility diligence behind the decision with regulators for whom this would uses 87 percent less water, consumes 30 percent less energy, and be new," he states. has resulted in a 95 percent reduction in caustic cleaning chemicals used. Combine these metrics with the fact that the facility has KEY FACTORS OF SHIRE'S SUCCESS 26 percent less carbon emissions, and you can understand why Shire broke ground on the new facility and got its first regulatory the Lexington facility stands as a shining example of what it takes agency drug approval within three years. "No one had ever done to be U.S. Green Building Council LEED (Leadership in Energy this before," Ciambrone claims. "The first approval was based & Environmental Design) Certified. Shire seems to be playing its on the purification site with the approval of the bioreactors cards right, parlaying its business to 2012 year-end total revenues coming later. But the plant would not have been running if we of $4.68 billion — vaulting the company into the high-roller ranks had used the old paradigm of plant building." Shire deemed of Top 50 Big Pharma. Though the folks at Shire are proud of Project Atlas a success, and so did the industry. In 2011, ISPE being first, Ciambrone cautions you not to let the perception of recognized the pharma company with an honorable mention in being innovative to be the motivation behind any decision, but to its annual "Facility of the Year" awards program. For Ciambrone, be based in logic and the facts particular to your company. THE BEST LEADERSHIP ADVICE I'VE RECEIVED 24 LifeScienceLeader.com December 2013