Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Languages
Websites
Timeline
Generic

Theja Venugopal

Bangalore

Summary

Dynamic biopharma professional with hands-on expertise in downstream manufacturing, equipment qualification, and global clinical operations. Proven track record in managing validation lifecycles through ValGenesis, leading risk assessments, and streamlining CAPA and change control workflows via TrackWise. Skilled in interpreting complex clinical protocols to build strategic study calendars and budgets for U.S.-based clients across oncology and non-oncology trials. Known for bridging technical precision with cross-functional collaboration to drive audit readiness and regulatory compliance.

Overview

3
3
years of professional experience
1
1
Certification

Work History

Research Associate II

Advarra
Bangalore
01.2024 - 03.2025
  • Interpreted complex clinical trial protocols to develop and enhance study calendars and budgets across diverse therapeutic areas, including oncology and non-oncology studies.

    Collaborated closely with clinical study teams and USA-based clients to tailor study calendars and budgets in line with sponsor expectations and protocol-specific requirements.

    Supported global clinical trial operations by building accurate, protocol-driven calendar structures and aligning cost components to timelines and trial complexity.

    Worked with the product technical team to troubleshoot and resolve calendar-building issues and platform bugs, contributing to improved functionality and user experience.

    Utilized internal case management and tracking systems to manage work assignments, ensure timely task completion, and maintain audit readiness.

    Participated in internal discussions and meetings to support protocol design, clarify study requirements, and contribute to process improvement initiatives.

Executive

Biocon Biologics Limited
Bangalore
03.2022 - 10.2023
  • Led end-to-end qualification of downstream process equipment and cold storage facilities in compliance with regulatory guidelines.

    Authored, reviewed, and executed qualification protocols (User Requirement Matrix, Risk Assessments, Design Qualification, etc.) using ValGenesis, an electronic validation lifecycle management system (eVLMS).

    Collaborated with Quality Management Systems (QMS) team to initiate and implement Change Controls and CAPA through TrackWise; conducted deviation investigations using Fishbone (Ishikawa) and Flowchart techniques.

    Successfully managed commissioning, qualification, and decommissioning activities of equipment and utilities, including execution of Re-Qualification (RQ) schedules.

    Performed temperature mapping studies and created sensor placement rationales to ensure GDP/GMP compliance.

    Reviewed and approved Batch Manufacturing Records (BMRs), process validation documents, and checklists for regulatory submissions and audits.

    Conducted risk assessments within downstream manufacturing, ensuring mitigation strategies and audit readiness.

    Managed documentation lifecycle: creation, review, revision, and archival of SOPs, BMRs, checklists, and validation documents.

    Oversaw training administration within the manufacturing team using SAP SF VLMS, including OJT module creation, role-specific curriculum development, and learning data maintenance.

    Participated actively in internal and Qualified Person (QP) audits, ensuring regulatory compliance and documentation integrity.

Education

Graduate Certificate - Biosciences

Biocon Academy - Keck Graduate Institute
Bangalore, Karnataka
03-2022

Master of Science - Biochemistry

St Aloysius College (Mangalore University)
Mangalore, Karnataka
10-2021

Bachelor of Science - Biotechnology, Biochemistry And Genetics

Garden City College (Bangalore University)
Bangalore, Karnataka
06-2019

Skills

  • Clinical Protocol Interpretation
  • GMP and GCP compliance
  • Validation Lifecycle Management
  • Change Control and CAPA Management (TrackWise)
  • Process qualification and equipment qualification
  • Risk Assessment and Deviation Management
  • Budget planning in clinical trials
  • Cross-functional collaboration
  • Document control and audit readiness
  • Training and Learning Management
  • Regulatory compliance
  • Written communication
  • Effective communication

Accomplishments

  • Biocon Biologics ‘Go Getter Award’ for exceptional and ingenious contributions to meeting functional and organizational goals
  • Alpha Grade 'O' for Outstanding and Silver Medal in M.S. C. Biochemistry

Certification

  • Lab Scale and Pilot Scale Fermentation Training - Biozeen (Bangalore, Karnataka)
  • Computer System Validation - Udemy
  • Genome Engineering CRISPR Advanced Certification Program - CRISPR Biotech Engineering
  • IELTS - Band 8

Languages

Malayalam
First Language
Hindi
Intermediate (B1)
B1
English
Proficient (C2)
C2

Timeline

Research Associate II

Advarra
01.2024 - 03.2025

Executive

Biocon Biologics Limited
03.2022 - 10.2023

Graduate Certificate - Biosciences

Biocon Academy - Keck Graduate Institute

Master of Science - Biochemistry

St Aloysius College (Mangalore University)

Bachelor of Science - Biotechnology, Biochemistry And Genetics

Garden City College (Bangalore University)

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Theja Venugopal