Dr. Bharat Kumar Agarwal

Analytical Professional with 24 years of experience including more than 15 year’s experience in leadership role in Analytical Research of Discovery and Generic Product & Drug substance (NCE’s and API) development. Seeking senior level assignments in ADL/AQA/DQA

• Currently working with Torrent Pharmaceutical Limited, R&D Center Gandhinagar as an Assistant General Manager- ADL.
• Leading a team of 60 scientists and responsible for US, EU, BR, ROW and India Market product development along with Alternate vendor management and market extension and Brazil regularization.
• Holds good exposure in API, formulations analytical R&D, Design Quality Assurance, GMP, GLP and well versed with various regulatory guidelines.
• Highly effective in leading a group of analysts & meeting deliverables in different areas like New chemical entity (NCE/IND), Oral Solid Dosage, Topical, Oral Liquids formulations including in-house API.
• Working on NIP and NIF strategies and developing analytical methods using updated analytical instrumental techniques such as HPLC, UPLC, HPIC, HRMS, LCMS/MS, GC/MS, ICPMS, XRD, DSC, TGA, newer spectrophotometers, etc.
• Providing leadership, guidance and manage the direct activities of the Analytical R&D.
• Ensuring QMS investigations using various tools to identify root causes and bring down IOOSR. Ensured implementation, harmonization of Global CAPA’s arising through regulatory inspections.
• Supporting QC in resolving issues related to OOS and OOT
• Developed and validated analytical methods for API, OSD (Tablets, Capsules, granules topical, Fixed Dosage Combinations)
• USP/EP equivalency studies and development of USP /EP Alternative methods.
• Driving RFT (Right First Time) and TAT (Turn Around Time) behaviors in the Analytical laboratory by encouraging/mentoring staff identifying and implementing improvements
• Skilled in Analytical Method Development, Method validations, stability studies, data extrapolation and shelf life extension of products, GLP documentation, Method Transfers and client management.

“Investigation of Degradation Kinetics, Isolation and Characterization of Degradation Products of CDRI Candidate drug”.

Summary of Research Work (Ph.D):

• Physicochemical Characterization of CDRI Candidate drugs
• Method development and Validation of Analytical methods
• Conducting stability studies of CDRI Candidate drugs, according to ICH guidelines.
• Isolation and characterization of degradation products and impurities of CDRI candidate drugs
• Study of Degradation Kinetics

• Responsible for leading, directing, conducting and supporting laboratory investigations to develop, improve, and optimize processes and analytical technologies for drug products.
• Developing Plans/Schedules for Resources and overseeing all activities to ensure timely completion of projects. Expertise in foreseeing practical challenges, project specific requirement and Manpower with all available resources
• Providing support for Formulation development, DMF, ANDA Submissions and IND enabling studies.
• Preparing, reviewing and monitoring analytical method development and validation as per QbD for IND & ANDA filings.
• Preparing protocols and Reports for Analytical Method Validation and Respective Analytical Method Transfers
• Pre-formulations /Hold time studies/Posology (NG/G/PEG), Food effect studies.
• >50 formulation,> 15 API dossiers filed for US/EU/Brazil/ROW, 3 IND filed for India and Brazil.
• Designing studies according to QbD/ regulatory requirement to support CMC as well as CTD filing.
• Dissolutions Sciences (CDP, Multimedia dissolutions, Biowaivers studies, IVIVC/R, Bio relevant Media Selection)
• Proficient in developing new analytical methods and improving the existing methods as per product parameters.
• Developing and validating methods for cleaning, elemental analysis (ICH Q3D) nitrosamine, NDSRI and Genotoxic impurities for API and Finished Products.
• Responsible for establishing the budget (Planning capex and budget review) for the Analytical department
• Chiral method development and respective method validations of enantiomers; troubleshooting problems in physical characterization of APIs and drug products.
• Managing interpretation and structural elucidation of drug molecules and its impurities by isolating the impurities by Prep HPLC.
• Finalizing the impurity profile and finalizing the specs as per ICH guidelines and daily dosage; handling documentation of analytical development history reports and setting specifications.
• Evaluating technical reports for laboratory procedures, validation reports and method transfer reports and new techniques & methodologies for analysis of drug substances, drug Products .
• Solid state Characterization, Polymorphism Studies and Reverse Engineering (XRD, Malvern Particle size, Microscope, DSC, TGA, G3ID, MultiRaman, NIR, DVS, SSA, Air jet )
• Well versed with various titration method development and wet analyses Autotitrator
• Accountable for instrument calibration as per GLP norms and coordinating for preparing URS/DQ/IQ/OQ/PQ for equipment, Utilities and Facility Qualification.
• Preparing the required standard testing procedures and standard operating procedures and reviewing existing SOP'S and STP`S.

• Qualified CSIR-NET July, 2001 for Lectureship in Chemical Sciences.
• NABL ISO/IEC 17025:2017

• Proficient in MS Office, PS-Next, Empower-3, Chromeleon, Lab Solutions, LMS, eLN, LIMS, Track Wise,

• US FDA
• EMEA
• ANVISA, TGA, NABL,
• NGCMA-GLP

• Date of Birth: 03/02/1976
• Marital Status: Married
• Passport No. S6884435