Controlled Environments spoke with Bikash Chatterjee, the author of the CE column “Regulatory Forum.” Bikash is President and Chief Science Officer of Pharmatech Associates, a Hayward, Calif.-based company that provides consulting and services to the regulated life science industry. Bikash has been involved in the biopharmaceutical, pharmaceutical, medical device, and diagnostics industry for over 30 years. His expertise includes site selection, project management, design, and validation of facilities for U.S. and European regulatory requirements. Bikash can be reached at [email protected].

Controlled Environments (CE): How did you get into your field?

Bikash Chatterjee (BC): While in college as a Biochemistry and Chemical Engineering double major, I did summer internships at nearby research and development organizations, one of which was Alza in Palo Alto. When I graduated I received a call from Syntex, another Alex Zaffaroni company located in the same business park, for a role in the R&D organization and I jumped at the opportunity.

CE: What is a typical day like for you?

BC: My day is a combination of WebEx-type meetings and teleconferences with team members and clients. We support projects all over the world, so my day can begin quite early — around 5:30 in the morning — and as a night owl, this is not my favorite time of day. Many of my overseas contacts are in senior leadership positions and as our projects tend to be strategic to their businesses I often make myself available from midnight to 2 a.m., if there is a need to connect.

CE: What are you most often asked to speak about at conferences and trade shows?

BC: Among the top of the biggest issues facing the industry so the topics vary. Most recently I have been very active providing practical models and case studies for meeting the U.S. and EU’s latest requirements for Process Validation and Quality by Design. More recently Data Integrity and Combination products have been gaining interest. We are fortunate to work on many of the latest programs in personalized medicine, next-generation gene sequencing and LDTs, which provides us with valuable practical insight on how to be successful with these types of programs.

CE: What’s the most surprising thing you’ve learned in your career?


BC: I learned very early on to surround yourself with strong people who are not afraid to disagree with you. Throughout my career, the ability to thoughtfully debate alternatives has been an important element to my career and to the personal satisfaction I derive from tackling difficult problems.

CE: What do you consider the highlight of your career?

BC: It is difficult to choose one event as the highlight. The work we did at Aradigm was groundbreaking. The technology was being developed at the same time we were inventing the equipment to manufacture it. The tolerances and control strategies required to build this equipment were orders of magnitude beyond anything the industry had ever done so it required an extraordinary group of individuals who were capable of pooling their collective expertise in a manner that could quickly solve complex problems. And we did it time and time again.

CE: If you had to do something else for a living, what would it be?

BC: Probably teach. I enjoy creating technical programs and writing. I recently finished my book, Applying Lean Six Sigma in Pharmaceutical Industry, which was a bucket list item for me.

CE: If you could give just one piece of advice to cleanroom facility managers, what would it be?

BC: Understand the scientific intent behind the regulations. This will prepare you better to handle the challenges related to managing controlled environments and lead you to a better problem resolution than simply looking at the regulations

CE: Is there anything else you’d like to share with the readers of Controlled Environments?

BC: I could not imagine how much I enjoy this industry. To have the opportunity to influence the landscape for healthcare around the world is something I could never have dreamed of when I first entered the industry. To be a life-long learner and still be challenged at this point in my career is something I cherish and keeps is one reason I Iook forward to every day at Pharmatech.