Harshith Kumar

Background

About Harshith Kumar

I’ve been working in pharmaceutical manufacturing for over six years, with a strong focus on clinical trial production. My experience includes operating bioreactors, particularly Icellus Bioreactors, and handling downstream purification processes like TFF(Tangential Flow Filtration) and chromatography, which is a key part of this role. I've been heavily involved in scaling up mammalian cell production, ensuring quality, and troubleshooting equipment to keep production on track. I’ve also spent a lot of time ensuring cGMP compliance, 21 CFR 210, conducting deviation investigations, and implementing corrective actions when needed, which I see as an important part of this position. I enjoy leading these investigations and finding solutions that not only address the immediate problem but also help improve the overall process. I’m especially passionate about working with teams and mentoring others to ensure that the process is executed smoothly and everyone is aligned. I find that when everyone is well-trained and engaged, it makes a big difference in meeting tight deadlines and maintaining high-quality results. I thrive in a fast-paced environment and enjoy the challenge of staying on top of production schedules, especially in a clinical trial setting where precision is crucial."