Mousumi Dutta

Manufacturing Executive with 2+ years of hands-on experience in GMP-grade cell and gene therapy production, including CAR-T cell manufacturing in Grade A/B/C cleanrooms. Skilled across the full manufacturing lifecycle — cell isolation, activation, expansion, harvesting, cryopreservation, and controlled-rate freezing — with a track record of authoring GMP quality documentation (SOPs, validation protocols, change controls, risk assessments) and driving process improvements. Strong cross-functional collaborator with QA, QC, and R&D teams; adept at translating regulatory requirements into reliable, audit-ready manufacturing operations.

Manufacturing Executive - Immunoadaptive Cell Therapy — NexCAR19 - Navi Mumbai, India

(2025-07)

• Execute end-to-end mammalian cell culture operations in GMP-grade cleanroom environments (Grade A, B, and C) for CAR-T cell manufacturing, ensuring full compliance with batch records and regulatory standards.
• Perform cell isolation, activation, expansion, and harvesting under aseptic conditions, coordinating smooth workflow across the end-to-end production process.
• Manage downstream handling including cryopreservation, controlled-rate freezing, and storage of cell-based products.
• Contribute to R&D on an Anti-CD20 CAR-T manufacturing process; designed an automated media aliquoting system using a peristaltic pump, reducing manual processing time.
• Author GMP quality documentation — SOPs, Process Validation Protocols, Change Controls, Risk Assessments, Impact Assessments, and Technology Transfer documents.
• Ensure compliance with GMP, GLP, GDP, and regulatory quality standards across manufacturing operations.
• Collaborate cross-functionally with QA, QC, and R&D teams to streamline manufacturing operations and documentation workflows.

Production Technician - LV Prasad Eye Institute - Hyderabad, India

(2024-04 - 2025-06)

Biomimetic Hydrogel for Treatment of Blinding Corneal Disease (Preclinical Study)

• Carried out batch manufacturing of limbal stromal stem cells and hydrogel in a cGMP facility.
• Prepared manufacturing documentation including SOPs and Batch Manufacturing Records (BMRs) in accordance with GDP.
• Trained new recruits on manufacturing processes and the in-house Quality Management System (QMS).
• Supported the R&D team with method validation and related preclinical studies.
• Maintained facility operations and equipment upkeep, and managed inventory of raw materials and finished products, including master inventory records.

Master of Science - Biotechnology - Vidyasagar University (Oriental Institute of Science and Technology) (2021 - 2023) Burdwan, India

Bachelor of Science - Microbiology - The University of Burdwan (Vivekananda Mahavidyalaya) (2015 - 2019) Burdwan, India