Abirame Rajaganesh
Dr. Reddy's Laboratories
Chennai
6
Languages
7
years of professional experience
Results-driven Quality Control Scientist with 5+ years of expertise in biological and pharmaceutical quality control within strict GMP, GLP, and ICH-compliant environments. Specialized in analytical release testing (ELISA, HPLC/UPLC, flow cytometry, qPCR), method validation, stability studies, and out-of-specification (OOS/OOT) investigations for biologics, monoclonal antibodies (mAbs), and complex drug products. Proven track record of hosting global regulatory inspections (including USFDA & EMA) with zero critical observations. Adept at driving operational excellence, laboratory data integrity, and cross-functional quality compliance across commercial and R&D pipelines.
Work History
Quality Control Scientist – Biologics
6 Years 10 Months- GMP Quality Control & Testing: Lead routine commercial release testing, in-process testing, and ICH stability studies for multiple biosimilar products and monoclonal antibody (mAb) pipelines in a state-of-the-art cGMP facility.
- Instrumentation & Method Validation: Execute method validation, verification, and technology transfer protocols using advanced chromatography (HPLC/UPLC, SEC), electrophoresis (CE-SDS, IEF), ELISA, qPCR, SPR, and cell-based bioassays.
- Regulatory Inspections & Audit Readiness: Key contributor during major global regulatory audits, including USFDA and EMA inspections. Managed document preparation, technical query resolution, and data presentation, resulting in successful approvals with zero critical findings.
- Quality Event Investigations: Spearhead root-cause investigations for OOS, OOT, deviations, and non-conformances. Formulate and implement robust Corrective and Preventive Actions (CAPA) to maintain Right First Time (RFT) standards and process compliance.
- Technology Transfer: Managed technical transfers of complex bioanalytical testing methods from Development to QC operations while maintaining strict regulatory alignability.
- Team Leadership & Onboarding: Mentored and qualified 12+ junior scientists on laboratory safety, analytical techniques, GDP documentation, and compliance standards, accelerating team ramp-up times.
- Cross-Functional Collaboration: Partner with Manufacturing, Quality Assurance, Regulatory Affairs, and Process Development teams to address quality events and continuous improvement initiatives.
Education
Master of Science - Biotechnology
Bachelor of Science - Biotechnology
Skills
Quality control compliance and cGMP / cGLP Systems
Assay development
Method validation
USFDA & EMA Inspection Readiness
OOS / OOT / Non-Conformance Investigations
CAPA implementation
ICH Stability Testing
Analytical techniques
Data analysis software
Bioinformatics databases & tools
Technology transfer
Method Validation & Verification
LIMS / QMS Systems
Cross-functional Technical Support
Trend Analysis and Statistical Data Interpretation
Laboratory Onboarding & Mentorship
Accomplishments
- Management Excellence Awards: Received multiple organizational certificates and accolades at Dr. Reddy's Laboratories for outstanding leadership during audit preparations and successful technology transfers.
- Right-First-Time (RFT) Award: Recognized for maintaining exceptional analytical compliance and zero-error documentation metrics across consecutive operational quarters.
Languages known
Tamil
C2
Bilingual or Proficient
English
C2
Bilingual or Proficient
Hindi
C1
Advanced
German
B1
Intermediate
Russian
A2
Elementary
Sanskrit (Saṃskṛta)
A2
Elementary
Timeline
Quality Control Scientist – Biologics
Dr. Reddy's Laboratories
05.2019 - 03.2026Read More
DGVC autonomous college
Bachelor of Science from Biotechnology
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SASTRA Deemed University
Master of Science from Biotechnology
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