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Praathibha Sripadhan

@praathibhasripadhan

Quality Assurance Specialist at ZEO ScientifiX, Inc., overseeing cGMP biologic release and process validation for patient-specific products.

India

Message

At ZEO ScientifiX, Inc., I provide quality oversight for a cGMP biologic drug product, from patient sample receipt through manufacturing, testing, and final release. I maintain the Quality Management System and lead process validation and risk management activities.

At Vivex Biologics, Inc., I developed and validated assays and disease models for biologic allografts, supporting product development through commercial readiness. I also contributed to lab digital transformation, peer-reviewed publications, and scientific conference presentations.

Experience

Work history, roles, and key accomplishments

Current

Quality Assurance Specialist

Current

ZEO ScientifiX, Inc.

May 2025 - Present (1 year 5 months)

Provides end-to-end quality oversight for a cGMP-manufactured biologic drug product, including batch record review, CAPA investigations, and internal audits. Administers the QMS and document control using Revver.

GMP QMS CAPA Change Control Deviation Management Internal Audit Batch Record Review Document Control Revver Process Validation Risk Management FDA Regulations ISO Standards

Associate Scientist

Vivex Biologics, Inc.

Aug 2020 - Jan 2024 (3 years 5 months)

Led R&D activities for biologic product lines, developed and validated in vitro disease models, and designed analytical assays including ELISA, flow cytometry, and multiplex cytokine profiling. Drove lab digital transformation and authored technical reports and SOPs.

Assay Development ELISA Flow Cytometry Multiplex Immunoassays (Luminex MSD)Luminex Magpix Luminex Cell Culture DOE (Design Of Experiments)ELN Migration Graphpad Prism Data Visualization Technical Writer SOP Development Technology Transfer

Research Technician

Nova Southeastern University

Apr 2019 - Aug 2020 (1 year 4 months)

Supported development of a high-content screening assay targeting hnRNPH2 in melanoma cell lines, conducted biomarker analysis and cell-based assay troubleshooting, and contributed to assay validation and scale-up.

High Content Imaging Assay Development Cell Culture Biomarker Analysis Protein Isolation 384 Well Plate Handling 1536 Well GFP Melanoma

Research Associate II

Georgetown University

Oct 2013 - Dec 2016 (3 years 2 months)

Developed patient-specific cancer research models for pancreatic adenocarcinoma and adenoid cystic carcinoma, applied conditional reprogramming techniques, and trained medical and research professionals.

Cancer Research Patient Derived Tumour Models Conditional Reprogramming Cell Culture Translational Research Training National Institute of Health Oncology

Research Associate I

AstraZeneca

Jan 2012 - Sep 2013 (1 year 8 months)

Managed cryopreservation and banking of 100+ mammalian and insect cell lines under GLP-aligned quality controls, performed Mycoplasma detection assays, and conducted PBMC and T-cell isolation with flow cytometry.