A highly motivated professional with a strong academic foundation in immunology and biotechnology, currently completing an M.Sc. in Immunotherapeutics (Trinity College Dublin) with a focus on therapeutic design and translational research. Experienced as a Production Specialist at Dr. Reddy's Laboratories, where I led sterile upstream manufacturing operations in GMP-controlled cleanroom environments, managed equipment qualification, and executed process validation. Proven ability to troubleshoot batch deviations and maintain quality documentation, including GxP, MES PAS-X, and SAP. My expertise is complemented by valuable industry exposure to clinical research operations and flow cytometry from an internship at the global CRO, ICON Plc .
Overview
2
2
years of professional experience
1
1
Certification
Work History
Intern
ICON Plc
02.2025 - 05.2025
Conducted precise flow cytometry projects, boosting research and team efficiency.
Streamlined data processes, achieving measurable improvements in research outcomes.
Maintained accurate records, supporting team goals, and ensuring research accuracy.
Utilizes critical thinking to identify process inefficiencies, contributing to enhanced data and research outcomes.
Gaining knowledge about the structure and functions of a flow cytometer.
Gaining hands-on experience in panel design, cocktail preparation, and data analysis.
Learning all the steps involved in different assays and following GLP, GMP, GCLP, GDPR, ISO standards, and LIMS.
Production Specialist
Dr. Reddy's Laboratories Ltd
09.2023 - 07.2024
Led and supported sterile upstream manufacturing operations for cell culture in GMP-controlled cleanroom environments, ensuring data integrity, sterility assurance, and adherence to production schedules.
Executed equipment qualification and process validation activities.
Collaborated with MSAT, PD, and tech transfer teams to troubleshoot batch deviations, analyze atypical trends, and investigate root causes.
Ensured all upstream manufacturing processes were executed as per the original schedule without any deviations and batch losses.
Prepare and perform cleaning methodologies (CIP, SIP) for used equipment and vessels.
Maintaining logbooks, batch records for the manufacturing process as per GDPR.
Managed and executed batch records within the Manufacturing Execution System (MES), specifically PAS-X , ensuring real-time data integrity and compliance with Good Documentation Practices (GDP) for all critical upstream processes.
Supported Fed-Batch Manufacturing and large-scale cell culture operations by strictly controlling critical process parameters (CPP) using automation platforms like DeltaV, maintaining optimal conditions for high cell viability and product yield.
Actively involved in the execution and monitoring of process optimization and scale-up studies, utilizing technical documentation systems (e.g., SAP ) for material tracking and inventory management to enhance manufacturing efficiency.
Education
Master of Science - Immunotherapeutics
Trinity College Dublin
Dublin, Ireland
09.2025
Bachelor of Science (B.S.) - Life Sciences
Himachal Pradesh University
India
08.2023
Skills
Molecular Biology
Bioprocessing
Autoclave Operation
Laminar Flow
LIMS (Laboratory Information Management Systems)
Analytical Testing
GMP Compliance
CGMP
Quality Management
EHS Guidelines
Regulatory Compliance
CAPA & Deviation Handling
Data Integrity
Equipment Troubleshooting
Research Methodologies
Data Analysis
Scientific Writing
Literature Review
Verbal Communication
Technical Documentation
Team Collaboration
Microsoft Office (Word, Excel, PowerPoint)
ISO standards
TRAINING
NIBRT (National Institute for Bioprocessing Research and Training) - Bioprocessing Training (as part of MSc Immunotherapeutics)
Completed hands-on bioprocessing training at NIBRT as part of the Bioprocessing module
Gained practical exposure to GMP-compliant biomanufacturing environments
Participated in NIBRT facility tour and practical sessions focused on:
Cell Culture Setup
Column Packing and Ultrafiltration/Dial Filtration (UF/DF)
Bioreactor Steam-In-Place (SIP) procedures
Single-Use Wave Bioreactor Setup and Operation
Developed foundational skills in upstream and downstream bioprocessing techniques used in the production of biologics
PROJECTS
Biochemical Assessment of Rice Bean Genotypes, Shimla, India, 6 months, Conducted a six-month dedicated research project for my thesis, focusing on the biochemical assessment of 12 rice bean genotypes grown in Shimla, India, analyzing key nutritional and quality attributes such as protein, fiber, minerals, and anti-nutritional factors. Analyzed mineral content using an Atomic Absorption Spectrophotometer and fatty acids with Gas Chromatography., Estimated phenolic compounds with a UV Spectrophotometer and conducted biochemical assays (AOAC methods) for protein, fiber, and carbohydrate measurements. Additionally, used a centrifuge for protein fractionation and a pH meter for sample preparation and titration, demonstrating a broad range of technical skills in biochemical analysis. Effectively managed the six-month research project, overseeing all aspects from experimental design to data analysis., Demonstrated strong organizational skills by planning and scheduling lab activities, coordinating resources, maintaining detailed documentation, and troubleshooting challenges to ensure the timely completion of project milestones while adhering to research protocols and quality standards.
Certification
Introduction to Gene Therapy Manufacturing by NIBRT
Introduction to Cell Therapy Manufacturing By NIBRT