Dommata Naresh
Hyderabad
Summary
Senior Analytical Method Development & Validation professional with 11+ years of experience across Oral Solid Dosage (OSD) and Sterile Injectable products. Proven expertise in analytical method development, method validation, and method verification in line with ICH and global regulatory guidelines. Strong background in supporting regulatory submissions, ensuring audit readiness, and driving compliance through robust documentation and ALCOA+ data integrity practices. Experienced in technology transfer, stability studies, and cross-functional analytical support for product development and lifecycle management.
Overview
12
12
years of professional experience
Work History
Analytical Scientist
Dr. Reddy's Laboratories
Hyderabad, India (Remote)
11.2022 - Current
- Led analytical method development, validation, and verification activities for oral solid dosage forms and both Oral solid dosage forms and sterile injectable products in line with ICH and global regulatory guidelines.
- Executed method validation for Dissolution, assay, related substances in compliance with regulatory expectations for Oral dosage forms and injectable products.
- Executed analytical method verification for transferred methods to ensure robustness, accuracy, precision, and suitability for routine and development testing.
- Performed finished product analysis, sameness studies, and diluent compatibility studies to support formulation development and injectable product lifecycle management.
- Authored, reviewed, and approved method development reports, validation/verification protocols, and technical documents for internal use and regulatory submissions.
- Ensured full compliance with cGMP, GLP, and ALCOA+ data integrity principles throughout all analytical development activities.
- Supported analytical technology transfer to manufacturing sites, ensuring successful method implementation and troubleshooting.
- Coordinated with external laboratories for method verification and validation, critically reviewing protocols and reports for technical accuracy and regulatory compliance.
- Led IQ, OQ, and PQ activities for new analytical instruments to ensure qualification and regulatory acceptance.
- Acted as analytical SME during regulatory inspections and internal audits.
Senior Executive
MSN Labs R&D Center
Hyderabad, India (Remote)
04.2019 - 11.2022
- Led analytical method development and Support activities for multiple dosage forms with a focus on regulatory compliance.
- Supported regulatory filings by generating high-quality validation and analytical documentation.
- Provided technical leadership in method transfer and troubleshooting analytical issues.
- Ensured audit readiness and supported successful regulatory inspections.
- Self-motivated, with a strong sense of personal responsibility.
- Worked effectively in fast-paced environments.
- Skilled at working independently and collaboratively in a team environment.
Officer
Aspiro Pharma Pvt Ltd
Hyderabad, India
01.2017 - 01.2019
- Performed analytical method validation and routine QC testing for finished pharmaceutical products.
- Supported stability studies and method transfer activities.
- Maintained compliance with cGMP and GLP documentation standards.
- Streamlined operational workflows to enhance efficiency and reduce delays.
Assistant Chemist
Aurobindo Pharma Pvt Ltd
Hyderabad, India (Remote)
01.2014 - 01.2017
- Conducted finished product testing including assay, related substances, and routine quality control analysis.
- Gained hands-on experience with HPLC and wet chemistry techniques.
- Participated in US FDA and MHRA regulatory inspections and supported audit compliance activities.
- Conducted routine chemical analyses to ensure product quality and compliance with industry standards.
- Evaluated experimental data to identify trends, contributing to continuous improvement in quality assurance practices.
- Optimized laboratory processes for increased efficiency in sample testing and analysis.
Education
Master of Science - Organic Chemistry
Osmania University
Hyderabad, India06-2013
Bachelor of Science - Chemistry
Osmania University
Hyderabad, India05-2010
Skills
- Analytical Method Development & Validation (Injectables & Oral Solid Dosage)
- Method Verification & Technology Transfer
- Regulatory Compliance (US FDA, MHRA, WHO, EMA, ANVISA)
- Stability Studies & Regulatory Support
- Data Integrity (ALCOA) & ELN Documentation
- External Lab Management & Report Review
- Instrument Qualification (IQ/OQ/PQ)
- Audit Readiness & Regulatory Inspections
- Team Guidance & Technical Leadership
- Chromatography techniques
Languages
English
Hindi
Telugu
Timeline
Analytical Scientist
Dr. Reddy's Laboratories
11.2022 - Current
Senior Executive
MSN Labs R&D Center
04.2019 - 11.2022
Officer
Aspiro Pharma Pvt Ltd
01.2017 - 01.2019
Assistant Chemist
Aurobindo Pharma Pvt Ltd
01.2014 - 01.2017
Master of Science - Organic Chemistry
Osmania University
Bachelor of Science - Chemistry
Osmania University
Regulatory And Audit Experience
- US FDA
- MHRA
- WHO
- ANVISA (Brazil)