NIVAS GANESHBABU
Senior Research Associate - Analytical Development
Hosur,Tamil Nadu
Summary
Senior Research Associate – Analytical Development supports RP-HPLC method development, analytical method transfer, and biological drug substance testing for regulated biopharmaceutical programs. Leads sameness evaluation, RLD comparison, and technical gap assessment while strengthening GMP, QMS, and ALCOA+ compliance through investigations, CAPA, and laboratory troubleshooting. Coordinates instrument qualification, QRM, change controls, and SOP updates to keep analytical operations audit-ready and scientifically fit for purpose.
Overview
3
3
Languages
8
8
years of professional experience
Work History
SENIOR RESEARCH ASSOCIATE – ANALYTICAL DEVELOPMENT
STELIS BIOPHARMA LIMITED, BANGALORE
06.2026 - Current
- Lead analytical activities for sameness evaluation of GLP molecules, including comparative assessment of Reference Listed Drugs (RLDs) and in-house drug products.
- Support analytical method transfer through technical gap assessment, evaluation, and cross-functional coordination.
- Support analytical investigations and troubleshooting by evaluating analytical observations, potential causes, impact, and appropriate corrective actions.
- Contribute to deviation investigations, including Root Cause Investigation (RCI), impact assessment, CAPA identification, and implementation.
- Conduct Quality Risk Management (QRM) assessments for instrument and equipment qualification activities.
- Support procurement, qualification, and operational readiness of analytical instruments and laboratory equipment.
- Coordinate calibration, maintenance, troubleshooting, and service activities for laboratory systems and equipment.
- Support change controls, SOP revisions, GMP documentation, and continuous improvement activities while maintaining ALCOA+ and data-integrity principles.
RESEARCH ASSOCIATE – ANALYTICAL DEVELOPMENT
STELIS BIOPHARMA LIMITED, BANGALORE
01.2024 - 05.2026
- Supported analytical method development and optimization activities for biological drug substances.
- Supported RP-HPLC method development for purity estimation.
- Assisted analytical method transfer through gap assessments and coordination with relevant stakeholders.
- Assisted in instrument and equipment procurement, qualification, and implementation.
- Supported QRM assessments associated with qualification activities.
- Supported laboratory equipment maintenance, calibration, troubleshooting, change controls, and SOP revisions.
SENIOR EXECUTIVE – QUALITY CONTROL
BIOCON BIOLOGICS INDIA LIMITED, BANGALORE
07.2022 - 01.2024
- Managed in-process sample analysis and ensured timely communication of analytical results to Production.
- Served as Shift In-Charge, effectively allocating work among analysts and ensuring timely completion and release of results.
- Supported analysts in troubleshooting analytical issues and resolving laboratory challenges.
- Initiated and supported investigation of incidents, OOS, OOTs, and deviations in TrackWise.
- Performed preliminary investigations and recommended appropriate immediate actions for QMS events.
- Supported Production in identifying probable root causes associated with batch failures through analytical and process-related evaluation.
- Coordinated with Production and R&D during process validation activities and supported compilation and evaluation of analytical data.
- Played a major role in the successful implementation of LIMS within the QC organization.
- Prepared and executed cleaning verification protocols.
- Supported change controls, SOP revisions, equipment calibration, maintenance, troubleshooting, and audit readiness.
- Coordinated with cross-functional teams during USFDA, EMA, internal, and other regulatory audits.
- Managed chemical requirements and initiated SAP purchase requests based on operational needs and lead times.
- Coordinated calibration and outsourcing services with external vendors.
EXECUTIVE – QUALITY CONTROL
09.2019 - 06.2022
- Performed analysis of in-process stage samples and communicated results to Production within required timelines.
- Supported Production and R&D during process validation through analytical testing and data compilation.
- Initiated and supported QMS events including incidents, OOS, OOTs, and deviations in TrackWise.
- Supported investigation teams with analytical data, technical assessment, root-cause evaluation, and event closure.
- Contributed to LIMS implementation and laboratory process transition.
- Prepared and executed cleaning verification protocols.
- Supported change controls, SOP revisions, equipment calibration, maintenance, and troubleshooting.
- Supported internal and regulatory audit activities, including USFDA and EMA audits.
- Managed chemical availability and coordinated procurement and outsourced laboratory services.
TRAINEE – QUALITY CONTROL
02.2019 - 08.2019
- Supported routine QC laboratory activities and in-process sample analysis.
- Followed GMP, laboratory procedures, EHS requirements, and data-integrity practices.
- Supported documentation and day-to-day laboratory operations in a regulated pharmaceutical environment.
Education
M.Tech - Pharmaceutical Operations & Management
BITS Pilani – Work Integrated Learning Programme (WILP)
Pilani01-2024
B.Tech - Biotechnology
Bannari Amman Institute of Technology, Anna University
Sathyamangalam01-2019
HSC -
Ambal Matriculation Higher Secondary School, State Board
Coimbatore01-2015
SSLC -
Ambal Matriculation Higher Secondary School, State Board
Coimbatore01-2013
Skills
RP-HPLC
Method Development
Method Transfer
Gap Assessment
Sameness Evaluation
Analytical method validation
ICH Q2(R2) compliance
Forced degradation studies
Stability-indicating methods
GMP
OOS/OOT
Deviations
Root Cause Investigation
CAPA
Trend analysis
Analytical data review
Method robustness assessment
Specification setting
Technical report writing
Laboratory investigation documentation
Timeline
SENIOR RESEARCH ASSOCIATE – ANALYTICAL DEVELOPMENT
STELIS BIOPHARMA LIMITED, BANGALORE
06.2026 - Current
RESEARCH ASSOCIATE – ANALYTICAL DEVELOPMENT
STELIS BIOPHARMA LIMITED, BANGALORE
01.2024 - 05.2026
SENIOR EXECUTIVE – QUALITY CONTROL
BIOCON BIOLOGICS INDIA LIMITED, BANGALORE
07.2022 - 01.2024
EXECUTIVE – QUALITY CONTROL
09.2019 - 06.2022
TRAINEE – QUALITY CONTROL
02.2019 - 08.2019
M.Tech - Pharmaceutical Operations & Management
BITS Pilani – Work Integrated Learning Programme (WILP)
B.Tech - Biotechnology
Bannari Amman Institute of Technology, Anna University
HSC -
Ambal Matriculation Higher Secondary School, State Board
SSLC -
Ambal Matriculation Higher Secondary School, State Board