The 2024 ISPE Member of the Year

Niranjan Kulkarni

Senior Director, Consulting Services

CRB

Named in honor of Max Seales Yonker, a dedicated and influential member of ISPE who served as a source of inspiration during her battle with cancer, the award honors an ISPE Member who has made the most significant contribution to the Society during the past 12 months.

Kulkarni has been active with ISPE since joining 2011, starting with his local chapter and then volunteering to help organize conferences, writing guidance documents and articles for Pharmaceutical Engineering®, and mentoring Emerging Leaders.

He was nominated by Sam Kitchell, Chief Operating Officer of CRB. “Niranjan has volunteered countless hours with ISPE over the years, but in the past 12 months, he seems to be especially active in nearly every aspect of ISPE,” Kitchell said in his nomination letter. “It is for his exhaustive list of meaningful activities that I’m nominating him for this award. He is actively involved in multiple Community of Practice [CoP] Steering Committees and he has dedicated months of his time as a co-author on the ISPE Guide Advanced Therapy Medicinal Products: Allogeneic Cell Therapy and the ISPE Guide Advanced Therapy Medicinal Products: Autologous Cell Therapy. He’s spent time preparing, presenting, and leading on-stage sessions, and still makes time to peer review articles for Pharmaceutical Engineering. He also encourages CRB’s young professionals and his clients to get involved with ISPE and their local Chapters every chance he gets. He is an all-around champion of ISPE.”

Kulkarni grew up in India, where his mother worked for Novartis. This made him aware of the importance of pharmaceutical engineering, although he did not start his career in the industry. “Initially, I worked at Dalal Engineering as a mechanical engineer working in the heavy machine industry on vibratory machines and finishing machines with centrifuges and pumps,” Kulkarni said. “I came to the US for my master’s degree and PhD, and learned a lot of simulation techniques, data modeling, financial modeling, and computer modeling. Luckily, I found a mentor with shared interests along the way, and he got me interested in the pharma industry again. I was curious to see how he was applying these modeling and simulation techniques in the life sciences and pharmaceutical industries.”

Kulkarni has been with CRB for the past 13 years, currently serving as the Senior Director of Consulting Services. He has a doctoral degree in industrial and systems engineering from Binghamton University, Binghamton, New York, US. He is also a certified Lean Six Sigma Master Black Belt with more than 15 years of experience in business process and data modeling, operations and process simulations, process improvements, layout optimizations, and supply chain management. He has worked with the pharmaceutical, biotechnology, chemical, semiconductor, electronics assembly and packaging, and manufacturing industries.

“At CRB, we help our life science and food and beverage clients make data-driven decisions, be it justifying a business case, investing in technology, trying to improve the efficiencies of their current operations, or creating lean designs from the onset. We use modeling and simulations, sustainability and strategic facility planning techniques, paired with Industry 4.0 (Pharma 4.0™) solutions to give clients the tools and means to make products faster without sacrificing quality,” Kulkarni said.

“One of the projects I’m most proud of is one where the client asked us how they would need to expand their facility in order to expand operations,” he said. “After evaluating their current processes, we determined they could accomplish their goals without moving a single wall. That was accomplished by challenging the status quo to figure out new ways of performing their tasks, improving the way they had laid out their processes and lines, and identifying resource-sharing opportunities. With that, the need for expansion was completely eliminated and they were able to get their target goals for the next five years in the space that they had.”

“Another one I’m proud of is more personal. We were designing an ATMP facility that would be producing therapies to fight cancer. The technology was still not quite commercial and there were a lot of unknowns. At the time, one of my family members had cancer and I knew they could benefit from the treatment. So, I was constantly asking myself, ‘How do we get this to the patient faster? How can I reduce the turnaround time, knowing that the owners don’t necessarily have an infinite supply of resources to allow that to happen?’ It was a nice challenge. We did a lot of simulations, a lot of modeling to figure out how the operation should run or what happens if certain things don’t work the intended way, and come up with the mitigation plan. We used all the information we had to inform the design and layout.”

Kulkarni says that digital innovations and computing technology have come a long way since he first started using them and that he thinks they will continue to improve and help bring about innovation in the pharmaceutical industry. “When I started simulations as a student way back, it was like moving blocks. But now, with the advancement of computing power, it is running so much more efficiently, and we can have parallel computing. The animation capabilities have really evolved so that you can visualize what’s going to happen in your facility during operations or construction. With parallel computing, you are able to run simulations very, very fast to the point where it can truly be a digital twin of the facility where it’s running almost near real time. And you can see what will happen if there are changes in the manufacturing process and what changes need to be made on the manufacturing floor.”

Constantly learning about new processes, techniques, and technologies is at the heart of everything Kulkarni does. ISPE has helped him tremendously, he said. “I enjoy learning immensely and have received so much knowledge from ISPE. The presentations at conferences, the Chapter, and webinars are very informative and important. When you begin networking, you are amazed at the amount of knowledge, experience, and diversity within the membership. ISPE brings it all together in one place. I was very fortunate to get a lot of good mentorship and encouragement from senior management at CRB and through the ISPE Boston Chapter.

“At the Chapter level, you can evolve as a leader, you can network and really figure out how you can help the industry. I am here thanks to a lot of support that I’ve received and I want to pass it on. Our Emerging Leaders truly are much more curious than I was back then. They’re asking good questions. They are exposed to a lot more information than we were when we were younger. I want them to have the same opportunity, or more, than I had. I try to help them understand what they can offer to the community, and at the same time, instill the philosophy of giving back to the community. I encourage them to get involved. It is very rewarding to see the amount of energy and refreshing ideas they bring to the table,” Kulkarni said.

His volunteer experience is long and diverse. He serves on the ISPE ATMP and SCOPE CoP steering committees, co-authors ISPE Guidance Documents, and helps organize ISPE conferences. Kulkarni is involved with the Institute of Industrial and Systems Engineers. He also helps his parents with supporting a village in Maharashtra, India, where they provide education in math, accounting, and communications and provide financial support so villagers can buy equipment and supplies to set up small businesses.

“I feel, at the end of the day, helping people is the most important thing you can do. It doesn’t matter if it is by providing medications through the work that we do or giving time—both are equally important,” he said.