Naga Mounika Nuguri

At Sarepta, I led end-to-end drug product MSAT activities for Duchenne Muscular Dystrophy and Limb-Girdle Muscular Dystrophy gene therapy programs, overseeing technology transfers, PPQ readiness, and ongoing CMO operations. I provided both virtual and on-site person-in-plant oversight, drove after-action reviews, and ensured CAPAs were closed in a timely manner. I established phase-appropriate GMP documentation, authored tech transfer plans, risk assessments, and process control strategy documents, and contributed to IND, BLA, and NDA submissions. Partnering with internal and external teams, I supported formulation equipment selection, designed process characterization studies, reviewed executed and master batch records, and managed SOWs and budget escalations, ensuring compliant, efficient, and robust DP manufacturing.

At SQZ Biotech, I spearheaded the process development and tech transfer of the company’s eAPC cell therapy platforms to CDMOs, while serving as SME and person-in-plant for GMP manufacturing. I led custom cryoformulation development for RBCs and PBMCs, performed stability and shelf-life studies, and optimized processes using LOVO, proprietary cell squeeze technology, and Repligen’s TFF systems. I authored and quality-verified CMC sections for IND submissions, managed a team of engineers, and presented program updates to senior management. I also qualified cryoshippers and credocubes to support global clinical supply chain operations, driving both technical and regulatory success for SQZ’s pipeline.

At Wave, I established comprehensive validation programs for oligonucleotide drug substances and drug products, executing Stage I and II process validation activities. I pioneered the company’s CCIT validation program in line with USP <1207>, built filter validation strategies with manufacturers, and collaborated with CDMOs to implement pre-PPQ readiness activities. By conducting risk assessments, defining DOEs, and identifying CPPs, I ensured that Wave’s clinical programs were supported with strong validation frameworks and regulatory compliance.

At Alnylam, I supported the validation of the first FDA-approved RNAi therapies, ONPATTRO and Givlaari, recognized as Breakthrough therapies. I directed PPQ readiness efforts, including hold time studies and batch size strategy, while serving as person-in-plant at CDMO sites for engineering and commercial runs. I collaborated closely with statisticians to build CPV programs, analyzed manufacturing data, and drafted regulatory responses during NDA reviews. My work also included cleaning validation (MACO, PDE), filter validation, container closure integrity studies, and support of regulatory inspections and PAIs, ensuring global compliance and successful approvals.

At Medtronic, I led validation initiatives supporting FDA submissions and global UDI compliance for medical devices. I validated secure data submission processes, created unique device identifiers, and authored scope and Part 11 assessment documentation. Additionally, I spearheaded a global batch master labeling project to centralize lot and serial data across ERP systems, improving labeling accuracy, compliance, and operational efficiency across sites.

Worked for Avco client sites (Novartis and Medtronic) as a Validation Engineer

At Novartis, I re-validated over a dozen commercial drug product manufacturing processes and implemented CPV plans to ensure long-term process robustness. I authored cleaning verification and APR sub-reports, performed FMEAs and DOE-driven risk assessments, and analyzed in-process and analytical data using Minitab. My work included statistical evaluation of process capability (Cpk/Ppk), SCADA system data reviews, and process justification studies, providing critical insights that strengthened compliance and ongoing monitoring strategies for GMP operations.