Sunith N
Executive in Biosimilar Process at Biocon Biologics | Bengaluru, Karnataka, India
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Sunith N. currently serves as an Executive in Biosimilar Process at Biocon Biologics, where he plays a pivotal role in advancing the company's biosimilar manufacturing capabilities. His expertise primarily focuses on downstream processes in biosimilar production, ensuring that each stage—from purification to formulation—meets stringent quality and regulatory standards. Sunith’s deep understanding of molecular biology and bioprocessing techniques enables him to optimize process parameters, troubleshoot complex production challenges, and implement robust corrective and preventive actions (CAPA). His proficiency in documentation and data standards ensures compliance with industry regulations such as GMP, FDA, and EMA guidelines, facilitating seamless audits and quality assurance activities.
In his current role, Sunith collaborates closely with cross-functional teams—including R&D, quality assurance, and regulatory affairs—to streamline processes and enhance product consistency. His experience with clinical trials and regulatory documentation further supports the development and approval of biosimilar products. Sunith’s strong project management skills and attention to detail help him oversee critical process validation activities, ensuring timely delivery of high-quality biosimilar therapeutics. His proficiency in data analysis tools like Microsoft Excel aids in monitoring process performance metrics and driving continuous improvement initiatives.
With a keen eye for troubleshooting and process optimization, Sunith N. is committed to contributing to innovative biopharmaceutical solutions that improve patient outcomes. His combination of technical expertise, team collaboration, and adherence to quality management principles positions him as a valuable asset in the dynamic landscape of biosimilar manufacturing.
Executive in Biosimilar Process at Biocon Biologics in December 2024 to Present
Executive in Biosimilars at Biocon Biologics in December 2024 to Present
Intern at Learning Labb Research Institute in April 2024 to December 2024
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The oxford college of science, Master of Science - Biochemistry, September 2026
Theoxfordcollegeofscience, Master of Science - MS, September 2026
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Medical Ultrasound
Medical Devices
Work Instructions
Desktop Template Creation
Stationery
High-Performance Liquid Chromatography (HPLC)
MedDRA
Independent Contributor
Timelines
Green Loan Principles (GLP)
Professional Manner
Archives Management
Post-Production
Customer Satisfaction
Project Oversight
Training Systems
Tracking Systems
CLINCIAL RESEARCH KNOWLEDGE
Global Regulatory Compliance
Client Relations
Team Collaboration
Ethics
Easily Adaptable
Communication Training
Team Leadership
Electronic Trial Master File (eTMF)
Document Review
Institutional Review Board (IRB)
Data Entry
Client Communication
Site Visits
Documentation
ICH
Metadata
Industry standards
Harmonization
Data Standards
Editing
Adobe Acrobat
Talent Planning
Regulatory Requirements
Oral Communication
Clinical Quality
Teamwork
Quality Control
Quality Auditing
Quality Assurance
Good Manufacturing Practice (GMP)
Corrective and Preventive Action (CAPA)
Target Audience
Creative Strategy
Summaries
Study Reports
Regulatory Submissions
Regulatory Standards
Investigator Brochures
Informed Consent
Contract Research Organization (CRO)
Clinical Reporting
Organization Skills
RCRA
Clinical Research Associates
Therapeutic Areas
Medical Terminology
Critical Thinking
Written Communication
DATA SAFETY AND MONITORING BOARDS FOR CLINICAL TRIALS
Microsoft Word
POWER POINT
Microsoft Office
INTRODUCTION TO CLINICAL RESEARCH
Good Clinical Practice (GCP)
Quality Procedures
Quality System
Quality Management
Electronic Document Management System (EDMS)
Localization
DNA Extraction
Real-Time Polymerase Chain Reaction (qPCR)
Molecular Biology
Polymerase Chain Reaction (PCR)
Multiplex PCR
Data Management
Clinical Research
Clinical Trials
Clinical Development
Clinical Data Management
Microsoft PowerPoint
Microsoft Excel
Troubleshooting , time managment
Online Advertising
Advertising
Leadership
Analytical Skills
English
Presentations
Strategy
Communication
Problem Solving
Research Skills
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Discover more about Biocon BiologicsWhat is Sunith N email address?
Email Sunith N at [email protected]. This email is the most updated Sunith N's email found in 2026.
How to contact Sunith N?
To contact Sunith N send an email to [email protected]. (updated on March 30, 2025)
What company does Sunith N work for?
Sunith N works for Biocon Biologics
What is Sunith N's role at Biocon Biologics?
Sunith N is Executive in Biosimilar Process
What is Sunith N's Phone Number?
Sunith N's phone (**) *** *** 248
What industry does Sunith N work in?
Sunith N works in the Research industry.
Sunith N Email Addresses
Sunith N Phone Numbers
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