Suresh Kumar

Skilled Senior Manager with over 19 years of experience in AR&D specializing in HPLC and GC methods development and validations. Demonstrated expertise in analyzing complex data and delivering accurate results. Proficient in utilizing advanced analytical techniques to support research and development processes.

• HPLC, Waters, Agilent & Shimadzu, Related substances, Assay & chiral purity
• UPLC, Waters, Chromatographic purity
• GC, Agilent, Residual Solvents & Purity
• UV, Perkin Elmer, Identification tests & cleaning validations
• FT-IR, Perkin Elmer, Identification tests
• Polarimeter, Rudolph, Optical activity
• KF and Potentiometric Titrator, Metrohm, Water content and titrations

I hereby declare that the information furnished above is true to the best of my knowledge.

· Responsible for Analytical HPLC and GC methods validation for API, Intermediates and KSMs

· Responsible for Analytical methods transfer to respective sites.

· Responsible for to fulfill the regulatory quires

· Development of HPLC methods for drug substances, intermediates and KSM’s.

· Preparation and review of documents such as

- Method development reports

- Spec and STPs for drug substances, Intermediates, in-process and KSM’s

- Analytical method validation protocols and reports

- Method transfer protocols

- Method equivalence reports

- Cleaning method validations by UV/HPLC for intermediates and drug substances

- Stability study protocols and reports to establish the packing conditions for APIs.

· Qualification and calibration of HPLC instruments.

· Responsible for preparation of SOPs

· Responsible for stability studies to establish the packing conditions for APIs

· Responsible for Evaluation of reference/working standards.

· Responsible for to train the analysts

· Coordinating with other team leaders to complete the ARD activities within timelines

like – Reference standard evaluation.

· Responsible for to indent the required glass ware, chemicals and columns for the validations and new projects.

· Implemented the calculations through Empower custom fields for Assay and Related substances

· Good hands on experience in handling & troubleshooting instruments like HPLC, UPLC, GC etc.

· Have exposure to GMP/GLP environment and documentation procedures required.