PRIYABRATA PANDA

Results-driven Analytical Research and Development (AR&D) professional with over 10 years of expertise in method development, validation, stability studies, technology transfer, and regulatory compliance across diverse therapeutic areas. Proficient in utilizing advanced analytical instruments such as HPLC and UV, with a strong background in preparing regulatory documents and supporting global filings for the US, EU, and ROW markets. Demonstrated history of ensuring data integrity and GLP/GMP compliance, along with a proven ability to foster cross-functional collaboration that drives successful product development and scale-up analysis. Committed to leveraging analytical skills and regulatory knowledge to contribute to innovative solutions in the pharmaceutical industry.

• Analytical Method Validation as per ICH guidelines and pharmacopeial requirements.
• Development, validation, verification, and transfer of analytical methods (Dissolution, Assay, RS).
• Impurity identification and isolation.
• Execution of routine, stability, and QbD-based analytical activities for formulation development and regulatory filings (ANDA).
• Preparation/review of COAs, STPs, SOPs, validation protocols, method equivalency & cleaning validation reports.
• Preparation of Method Development, Stability, Investigation & Test Reports.
• Transfer analytical methods to manufacturing sites and provide technical support for plant queries.
• Handling of regulatory submissions, deficiency responses, gap analysis, and scale-up support.
• Coordination with cross-functional teams, client discussions, and laboratory inventory management.
• Calibration, qualification (IQ/OQ/PQ), and maintenance of analytical instruments.
• Strict adherence to GLP, GMP, ICH, safety, and regulatory guidelines.

• HPLC, UPLC (Shimadzu, Dionex, Waters, Agilent – Chromeleon & Empower software)
• Particle Size Distribution (Malvern Mastersizer 3000)
• Dissolution Tester Type I, II, III (Electrolab, Lab India)
• Gas Chromatography (Agilent with Chromeleon software)

• Date of Birth: 1991-07-17
• Father’s Name: Mr. Janmejaya Panda
• Languages Known: English, Oriya, Hindi (Read/Write/Speak)
• Marital Status: Unmarried
• Principles: Hard & Smart Work, Punctuality
• Permanent Address: At: Begunia, PO: Khaira, Dist: Balasore, Odisha – 756048
• Place: Bangalore, India
• PRIYABRATA PANDA