Ankit Kumar Dubey
Research Associate at Dr. Reddy\'s Laboratories
- Role
- Research Associate at Dr. Reddy's Laboratories
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Ankit Kumar Dubey
Detail-oriented and proactive person with a strong background in R&D, biotechnology, and cross functional project execution. Proven ability to support end-to-end project lifecycle, manage stakeholders, identify risks, and ensure timely and quality delivery. Experienced in documentation, compliance, and communication across regulatory, research, and analytical functions with an aptitude for strategic planning, team collaboration, and tool-based project tracking.
Experience
Research Associate
Sep 2022 — Present · Hyderabad, IN
Development and qualification of ligand binding (ELISA’s), cell based and Surface Plasmon Resonance (SPR)(Biacore T200, Biacore 8K) assays as per the ICH guidelines. Planning and execution of various studies for biological characterization of molecule like stability, functional similarity, structure function relationship, QTPP and analytical comparability using SPR/ELISA/cell-based assays. Cell culture maintenance, preparation of master and working cell banks and their qualification. Responsible for response submission to regulatory agencies received during product filing for the various markets. Handling of QMS activities like Change Controls, incident management, CAPA, discussions and trainings with DQA. Preparation of documents like method development report (MDR), standard development procedure (SDP/MET), method qualification protocol (MQP), method qualification report (MQR), Analytical Similarity Report (CAA), equipment SOP using Document Management Software (DocHub). Contemporaneous documentation of the assay related activities in the Electronic Lab Notebook (ELN). Planning of preventive maintenance, calibration activity and Coordination with Lab operations team for responsible equipment’s. Maintaining GDP, GLP, and overall compliance while working. Involved in the global audit & inspection readiness for regulatory agencies like US FDA, EMA, MHRA.
Education
REVA University
Master of Science - MS
North-Eastern Hill University
Bachelor of Science (Honours)
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