From Concepts to Reality - Meet Young Professional Richi Sethi

Sethi took her own advice recently and responded enthusiastically when introduced to ISPE. “A colleague introduced me to Caroline Rocks (Senior Process Engineer, Global Engineering, AbbVie, and incoming Director on the ISPE International Board). She provided a very good initiation into an organization with which I look forward to getting more involved.”

This willingness to grow reflects Sethi’s approach to her vocation. While she’s currently working as a design engineer, Sethi remarked that she’d “be more than glad to move onto a more managerial role” in the future. “I would also like to be more actively involved in the ISPE India Affiliate and share my experience and learnings in the industry with others who are new to it,” she added.

Sethi, who holds a master’s degree in biomedical engineering from the prestigious Indian Institute of Technology (IIT) Bombay, was “fascinated by science” from an early age, although engineering was not her original plan: She wanted to be a doctor. An amusing anecdote illustrates her turning point.

“My mother was unwell and needed to go to the hospital. The closest one was a general hospital—not very privileged. Patients all around us were bleeding, vomiting. ‘My God!’ I thought. I left my mother in the waiting room and ran outside to get some fresh air. Moments later, I fainted. Finally, after 15 minutes, people managed to get me back inside. We were there to care for my mother, but I was overwhelmed. I told her, ‘I definitely cannot be a doctor.’ And that was the end of it.”

While her medical aspirations may have evaporated that day in the hospital, she began a four-year bachelor of engineering program at Panjab University, studying a wide range of subjects including tissue culture, bioprocess design, cell culture, and bionanotechnology. That led directly to her two-year master’s program at IIT,

where she specialized in nanotechnology and biomedical technology. During the second year of the program, however, Sethi made another career pivot.

“In my second-year project phase, I realized nanotech research was not my cup of tea, not only because I grew less interested in the research angle, but also since this field lacked ‘Vitamin M’ (money) and a proper facility—at least in India at that time. I had a strong desire to apply what I’d learned [in biomedical technology] and wanted to be on the front lines.”

Near the end of her postgraduate study she learned of an opportunity at Biocon. “Biocon was looking for people with an engineering mind who could solve real-life problems,” she said. Sethi described her start at the company as an ideal fit, but challenging nonetheless. “It was a totally different ball game—out of college and into the industry. Fortunately, I had a mentor. He’s my boss now. He made the transition very smooth for me.”

As a Biocon process engineer and assistant manager, Sethi works closely with her department to go from concepts to reality. “We lead the way. We build the processes for how to manufacture a drug at production scale using GMP. We need to build the facility itself, ensuring that it meets GMP qualifications. We have to consider market demands as well as regulatory requirements, and how our facility can respond to them.”

Asked to recall a particularly important moment in her time at Biocon, Sethi described an intense, 10-day FDA audit focused on the manufacture of biosimilar mAbs. A capacity expansion was under- way, and the project was being executed by her department. At the end of the audit, the drug earned FDA approval, and her team was “on top of the world.” She said that “years of planning, design, and execution gave rise to the facility as it stands today. It gives a sense of achievement and satisfaction to see the facility being attested at par with the best in the world by none other than US FDA—even greater so because we were the first to get there in the entire world. Our hard work paid off. Our process worked, and that brought a concept to reality at production scale. We were joyful, and this served as a morale booster to aim for and attain greater heights.”

Sethi is excited about the growth of the pharma industry in India. Asked about the upcoming 2018 ISPE Pharmaceutical Manufacturing Conference in Mumbai (15–17 October 2018), she commented, “It’s a great initiative to ensure quality and compliance to accepted regulatory standards. India, as an actively growing manufacturer of pharmaceuticals, is an ideal choice for this conference.”

Sethi’s generation of engineers work in an exciting era of rapid, transformational change. “Over the past 10 years we’ve gone from manual systems with operators to an increasingly automated production system,” she said. “Now when I talk to vendors, everything is automated. We want minimal operator intervention.” Sethi described this shift as a “dynamic” change with which “efficiencies have gone up, downtime has decreased, and yield has increased.” She explained that with less operator intervention and fewer hands on the process, there has been a notable reduction in sterility issues and batch losses due to error. “There is absolutely no human intervention” in many aspects of the process, Sethi remarked.

Of course, with this level of automation, the importance of good up-front design is emphasized. “We must have a detailed qualifications procedure. Each and every sequence has to be right at the beginning. Intense testing early on pays off at the end, and ultimately, that’s better for patients.”

The patient benefits afforded by these more efficient manufacturing systems are multifaceted, Sethi explained. “Now, with the ease of automation, we can modify batches by adjusting settings and alarms. It’s an aspect of machine learning—the system is so smart.”

Our hard work paid off. Our process worked, and that brought a concept to reality at production scale.

Automation is transforming all aspects of manufacturing—right down to automated hoists and other equipment in facilities, she continued.

That kind of dynamism—the ability and willingness to adapt to change—seems inborn in Sethi. From that moment in the hospital when she realized that her path led not to medicine but to engineering, she’s made a career out of responding to change. She’s found a way to bring intellectual curiosity and a passion for science to the front lines of the pharmaceutical industry.