SAIDI REDDY G

Analytical Research & Development Manager with M.Sc in Chemistry from Osmania University. Developed and validated analytical methods and conducted stability studies in compliance with ICH guidelines. Knowledgeable in Quality Management Systems aligned with US-FDA standards, contributing to organizational growth through expertise and leadership.

• Developed analytical methods for various drug substances, their intermediates and raw materials under various instrumentals and classical techniques.
• Experience in literature search for method development of new products and good interpretation of GC and HPLC data.
• Actively participated in the cross functional meetings and adhered to the timelines committed for the method development as per the agreement with R&D.
• Developed sensitive analytical methods for various Genotoxic impurities and validated.

Method development for various raw materials, intermediates and finished products of different drug substances Synthesized at R&D. Actively involved in investigation of unknown peaks observed in the methods and confirmed their mass numbers by either LCMS or GCMS as per requirements., Carrying out the calibrations as per master schedule., Design, evaluation and Monitoring of stability data generation for drug substances as per ICH., Stress testing to determine the intrinsic stability of the molecule., Carrying out the impurity profile programme for different drug substances, key intermediates and Key starting materials., Preparation and maintaining the calibration records for the instruments. Preparation of protocols & supporting documents for validations, stability programs, degradation studies etc. Evaluating the data of stability program, impurity profiles and validations.

• Telugu
• English
• Hindi

• Performing Literature Search
• Understanding & compliance with relevant Regulatory requirements
• Responsible for carrying out day to day work
• Design of experiments along with team
• Experimentation for method development stage wise
• Compilation of forced degradation & identification of unknown degraded impurities
• Compilation of stability data
• Method development progress report and presentations
• Preparation of test methods, method validation protocol and method validation report
• Execution work for method validation of HPLC, GC and Wet analysis techniques
• Analytical method transfer
• Execution of work for analytical related regulatory queries
• Maintenance of lab, equipments as per GMP/GLP

• Father's Name: G. Laxma Reddy
• Date of Birth: 05/04/80
• Nationality: Indian
• Marital Status: Married