Nikhil Bhalerao

About Nikhil Bhalerao

Dynamic and Results-driven professional with nearly 15 years of progressive experience…

Experience

1. Sr Scientist

   Kenvue

   Nov 2018 — Present · Mumbai, IN

   Personnel (Main duties):* Responsible to provide analytical support (Dissolution, Assay, Related substances, Residual solvents) for the developmental projects, late-stage development as well as Life Cycle management projects received from other Janssen sites.* Responsible for the preparation and review of test methods, In-process and FP Specifications, technical documents, protocols, reports and SOP’s whenever required.* Responsible to be an interface with contract laboratories, suppliers, customers and peers to define and improve project performance and expectations.* Responsible to analyze and interpret analytical data, statistical analysis, identify and interpret trends or patterns in complex data sets.* Responsible for tracking of pharmacopoeia monograph updates and knowledge sharing to analytical team members.Quality:* Responsible for implementation of corrective and preventive actions as per applicable standard operating procedures to meet cGMP requirements.* Responsible for following quality systems in all the activities meeting the cGMP requirements, Global Quality Manual and standards, local procedures and applicable regulations.* Responsible for data review and management for IO, OQ and PQ of instruments. Document Management:* Responsible for Preparation and review of Protocols, reports and other cGMP documents and ensuring adherence to applicable regulatory requirements, J&J policies, J&J standards & local procedures.* Responsible for preparation and review of Method Development reports, Method Validation Protocols/Reports, Test methods, Method Transfer Protocols/Reports, Method Introduction Protocols/Reports & other technical documents.* Review of 3rd party analyzed Test reports related to RM/ DP for CMO batches, including raw data.Handling of Events & Deviations:* Responsible for performing investigations and determination of root cause

Education

• STM Nagpur University

  M Pharmacy, Medicinal and Pharmaceutical Chemistry

• Institute of Pharmaceutical Education and Research

  M. Pharm, Pharmaceutical Medicinal Chemistry

  2007 — 2009

Skills

• Hplc
• Pharmaceutical Industry
• Sop
• Ectd
• Anda
• Drug Design
• Glp
• Formulation
• Organic Chemistry
• Chemistry
• Analysis
• Validation