Nidhuna Mani

Enthusiastic and highly proficient Research Associate with three years of experience in analytical instruments including GC, HPLC, UPLC, CE-SDS, and iCE. Strong background in sample analysis, calibration, method development, troubleshooting, documentation, GMP/GLP compliance, and data integrity within pharmaceutical laboratory environments.

Research Associate - Micro Labs Limited

(2023-01 - 2026-01)

• Conducted analytical method development for carryover impurities using GC and HPLC techniques as requested by the regulatory department to provide timely analytical support for regulatory and customer queries.
• Developed analytical methods and identified unknown peaks for raw materials, intermediates, and drug substances, generating corresponding Product Transfer Protocols (PTP).
• Performed routine analysis for raw materials, intermediates, drug substances, and working standards for qualification and release results, documenting outcomes via Analytical Test Reports (ATR).
• Prepared protocols based on development studies and executed validation and batch analysis in strict accordance with the protocol guidelines.
• Authored detailed reports of completed carryover studies adhering to approved protocols and established formats.
• Performed instrument calibrations according to Standard Operating Procedures (SOPs) and prepared timely reports.
• Maintained meticulous and accurate records, including laboratory notebooks, logbooks, and overall data integrity.
• Supported laboratory investigations regarding out-of-specification (OOS), atypical, and unexpected analytical results.
• Upheld strict compliance with GMP, GLP, laboratory safety regulations, and internal quality standards.
• Generated and reviewed analytical reports utilizing automated laboratory software systems, including Empower and CaliberLIMS.

Research and Development Intern - Biocon Biologics

(2022-07 - 2023-01)

• Executed HPLC analysis, including Size Exclusion Chromatography (SEC-HPLC) and Protein A-Affinity HPLC.
• Utilized iCE for charge variant analysis and CE-SDS analysis for purity and size variant determination.
• Gained hands-on experience and proficiency in operating LabWare eLN electronic laboratory notebook software.

Master of Science - Analytical Chemistry - Christ (Deemed to be University) – Bangalore, Karnataka (2019 - 2021)

Bachelor of Science - Chemistry - Nirmala College Muvattupuzha, MG University – Kerala (2016 - 2019)