Jun 2024 – Dec 2024 · 6 mos · Rockville, Maryland, United States · On-site

• Facilitated campaign readiness activities for the Benlysta campaign, including Batch Record revisions, and chromatography column preparation to ensure compliance with cGMP standards and seamless manufacturing execution in 20KL facility.
• Initiated and successfully implemented/closed 4 change controls to support manufacturing continuity and process improvement.
• Conducted comprehensive assessment of buffer preparation line loss using IP21 process historian tool to identify and mitigate risks of buffer volume deviations out of batch record ranges for all Benlysta buffers, enhancing process reliability and avoiding recurring deviation.
• Supported COFEPRIS regulatory audit and assisted with submitting response to Health Authority Queries (HAQs) from the FDA.
• Managed CPV program by performing real-time data analysis of the CPP’s and CQA’s, facilitating CPV meetings, and leading investigation on OOT observations throughout the campaign.
• Authored deviation, RCA and CAPA documentation, supported SAP operations, and reviewed Annual Product Reports (APR).
• Coordinated with various teams including Regulatory, Tech Ops, Data Analytics, and Supply Chain to execute and deliver short term cross departmental projects.

Sep 2023 – Dec 2025 · 2 yrs 3 mos · Boston, Massachusetts, United States

• Pharmaceutical Engineering Lab
• Prepared and calibrated bioreactor systems, managed media preparation and sterilization, performed upstream inoculation, culture monitoring, and sampling to track and model E. coli growth, RFP expression, oxygen uptake rate.
• Operated AKTA chromatography systems and analyzed results for Affinity, IEX, and HIC for protein purification and evaluated yield, purity, and recovery using chromatography traces and analytical methods.
• Project: Collaborated on RFP production from E. coli under varying glucose concentrations and incubation times; developed SOPs, maintained ELN records, and modeled expression using standard and modified Monod equations, with the modified model providing a better fit and revealing saturation limits for glucose and time.
• Pharmaceutical Sciences Lab
• Characterized nanoparticle size, charge using DLS, zeta potential analysis and cytotoxicity using MTS assay.
• Utilized fluorescence microscopy, ELISA, Western blotting, PCR, and gel electrophoresis to assess cellular uptake, protein expression, and gene silencing.
• Project: Investigated the efficacy of R6G-loaded gold and PLGA nanoparticles, with and without verapamil, in overcoming multidrug resistance by inhibiting P-glycoprotein efflux pump activity and inducing apoptosis in cancer cells

Jul 2022 – Jun 2023 · 11 mos · Vapi, Gujarat, India