Headline

Downstream MSAT Specialist | Turning purification & scale-up optimization to manufacturing gains for biopharma firms | 36% yield increase | ₹23Cr revenue impact | AKTA chromatography systems | Data-driven process control

About

In biologics manufacturing, yield is not just a technical metric. It is “Revenue”. When I began working in biologics manufacturing, I believed what most young engineers believe: If the science is right, the process will work. But during early scale-up projects, I saw something different. Development batches looked promising. Yet once we moved into GMP manufacturing, variability increased. Yield fluctuated. Deviations repeated. Investigations closed, but the same problems resurfaced. Teams worked harder, but the process didn’t always become stronger. 💡That’s when I realized: Downstream challenges are rarely just science problems. They are systems problems. So I built my approach around one principle: “Technical execution must be integrated with structured risk management, data analytics and GMP discipline.” Today, as a Downstream processing & MSAT specialist, I help biopharma enterprises strengthen purification processes, de-risk scale-up and improve manufacturing performance without compromising compliance. ⭐Here’s what that has translated into: 👉🏻36% improvement in downstream yield → ₹23 crore annual revenue impact 👉🏻Successful scale-up support for 3 biologics programs from development to commercial GMP 👉🏻25+ structured root cause investigations preventing recurrence 👉🏻75+ quality documents, investigation reports and change controls supporting sustained QMS compliance 💯My expertise spans: ➡️Chromatographic purification (AKTA systems) ➡️Tangential Flow Filtration (TFF), depth & sterile filtration ➡️HPLC analytics & statistical data evaluation ➡️Process optimization & scale-up risk mitigation ➡️IQ/OQ/PQ, URS & validation support ➡️Deviation management, CAPA implementation & GMP documentation ➡️Data-driven trend analysis using Excel & Power BI ❌Many organizations believe: Yield loss during scale-up is unavoidable. Deviations are part of manufacturing reality. Quality and productivity are opposing forces. ✅I have seen the opposite. When process science, structured investigations, and data-backed decisions work together, yield increases. Variability reduces. Compliance strengthens. And manufacturing becomes predictable. My focus is simple: Increase yield. Protect revenue. Reduce manufacturing risk. Enable confident commercial scale-up. If you are a biopharma leader looking for someone who can strengthen downstream purification, stabilize scale-up, or improve MSAT-driven manufacturing performance, then let’s connect. 📧My email ID: karthikga21@gmail.com

Location

Bengaluru

AI stack

cursor

opencode

Work experience

Senior Executive at Biocon Biologics, Aug 2023 - Present · 3 yrs 1 mo, Bengaluru, ● Executed GMP-compliant downstream purification (AKTA chromatography, TFF, depth and sterile filtration) supporting commercial manufacturing and 50+ HPLC-based product quality assessments. ● Led scale-up support for three biologics programs, mitigating scale-dependent risks and enabled smooth transition from development to GMP manufacturing. ● Conducted 25+ structured root cause investigations for process deviations using 5-Why and Ishikawa methodologies, and implemented CAPAs to strengthen process robustness and GMP compliance. ● Upgraded downstream process yield by 36% that contributed to ₹23 crore annual revenue growth while optimizing filtration vendor qualification to cut procurement cycle time. ● Collaborated cross-functionally with QA, QC, manufacturing and engineering to resolve technical deviations and support QMS compliance, authoring 75+ investigation reports, change controls and risk assessments.

Education

Master of Science - MS, Biotechnology, National Institute of Pharmaceutical Education and Research (NIPER) ,SAS NAGAR , Mohali

Bachelor of Pharmacy - BPharm, Pharmacy, Rajiv Gandhi University of Health Sciences