Bhavana Chikmagalur Raghunath
QC Specialist | Analytical Sciences | Method Validation | GMP Compliance
Baltimore,Maryland
Summary
Experienced quality and analytical science professional with 6+ years in GMP-regulated bio-pharmaceutical and CDMO environments, including Johnson & Johnson. Demonstrated success in analytical method validation, QC testing, deviation/CAPA management, and documentation review in support of clinical and commercial manufacturing. Skilled in LIMS, data trending, SOP authorship, and ensuring audit readiness aligned with global regulatory expectations (FDA, EMA, ICH). Strong cross-functional communicator, contributing to inspection preparedness, and mentoring junior team members.
Overview
8
8
years of professional experience
3
3
Certifications
Work History
Associate Scientist III
Catalent Pharma Solutions
10.2023 - Current
- Led method validation and transfer of ELISA, qPCR, ddPCR and potency assays supporting biologic programs.
- Authored and reviewed SOPs, validation protocols, and technical documents to meet cGMP and internal standards.
- Conducted data review and trending to support product release and stability programs.
- Executed deviation investigations and collaborated cross-functionally to implement CAPAs using TrackWise.
- Participated in internal inspections, lab walkthrough, and audit preparation with QA.
- Trained new team members on Complex assays, GMP documentation practices and assay data integrity standards.
QC Analyst – Bioassay Group
Johnson & Johnson
04.2022 - 04.2023
- Performed GMP-compliant QC testing for biologics using molecular biology and bioassay methods for batch release.
- Reviewed lab data, logbooks, and assay results to support regulatory compliance and audits.
- Participated in SOP revisions and provided input to internal inspection preparation.
- Led deviation investigations and documented outcomes in TrackWise in alignment with QA protocols.
Analyst II – Method Validation and Quality Support
Eurofins Biopharma Product Testing
11.2020 - 04.2022
- Conducted method transfer, validation and documentation across ELISA, SDS-PAGE, and potency assays.
- Led deviation investigations and collaborated with QA to implement risk-based CAPAs.
- Authored and maintained SOPs, technical reports, and documentation for client audits.
- Supported APQRs, internal audits, and client inspection readiness initiatives.
- Mentored junior analysts on SOP adherence, LIMS data entry, and quality documentation standards.
Research Associate
Genei Laboratories
06.2018 - 08.2019
- Executed molecular biology assays (microbial identification, qPCR, sequencing) and authored custom assay protocols.
- Maintained data integrity logs and supported calibration traceability of laboratory equipment.
- Supported technical troubleshooting and contributed to QA documentation for assay validation.
- Collaborated on client-focused development projects involving DNA/RNA-based methods.
Junior Scientist
Chromous Biotech
10.2017 - 06.2018
- Performed PCR, DNA extraction, and sequencing as part of molecular QC workflows.
- Drafted and revised SOPs and method documentation aligned with QA requirements.
- Conducted quality checks for reagents and supported complaint resolution processes.
- Participated in integrating improved primers and controls into testing pipelines.
Education
Master of Science - Biotherapeutics And Business
University College Dublin
Dublin, Ireland 05.2001 -
Bachelor of Engineering - Biotechnology
M. S. Ramaiah Institute of Technology
Bengaluru, India 05.2001 -
Technical Diploma - Biotechnology
Acharya Polytechnic
Bengaluru, India 05.2001 -
Core Competencies
- Analytical Testing: ELISA, qPCR, ddPCR, Potency Assays, Western Blot, HPLC and Spectrophotometry
- Method Development, Transfer, and Validation (ICH Q2(R2))
- Documentation: SOPs, Validation Protocols, Technical Reports, WI Review
- Quality Systems: LIMS, TrackWise, EDMS
- Regulatory Compliance: GMP, GDP, FDA/EMA, USP/EP Standards
- Deviation Investigation, RCA, CAPA
- Data Review & Trending, Change Control
- Cross-functional Collaboration (QA, QC, MSAT, Operations)
- Continuous Improvement (Lean, 6S, RCA Tools)
Certification
ASQ Lean Six Sigma Green Belt (CSSGB)
Timeline
ASQ Lean Six Sigma Green Belt (CSSGB)
06-2025
USP eLearning: Deviations, RCA, CAPA
12-2024
ISPE GMP Fundamentals – Records and Reports
12-2024
Associate Scientist III
Catalent Pharma Solutions
10.2023 - Current
QC Analyst – Bioassay Group
Johnson & Johnson
04.2022 - 04.2023
Analyst II – Method Validation and Quality Support
Eurofins Biopharma Product Testing
11.2020 - 04.2022
Research Associate
Genei Laboratories
06.2018 - 08.2019
Junior Scientist
Chromous Biotech
10.2017 - 06.2018
Master of Science - Biotherapeutics And Business
University College Dublin
05.2001 -
Bachelor of Engineering - Biotechnology
M. S. Ramaiah Institute of Technology
05.2001 -
Technical Diploma - Biotechnology
Acharya Polytechnic
05.2001 -
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