NIKHIL BHALERAO
Senior Scientist
Thane
Summary
Results-driven professional with nearly 14 years of experience in Analytical Method Development, Validation and Transfer for oncology drugs, injectables and oral solids products. Competent in statistical analysis, DOE-based analytical method development and effective collaboration across teams for successful project completion. Proficient in Stability studies as per ICH guidelines including protocol preparation, report review, and OOS/OOT handling. Skilled in ensuring compliance with cGMP standards and maintaining quality systems in laboratory environments. Skilled in cross-functional collaboration, regulatory affairs and driving continuous improvement within quality systems.
Overview
15
15
years of professional experience
7
7
years of post-secondary education
3
3
Languages
Work History
Sr. Scientist
Janssen Pharmaceuticals (on Payroll of GVW Tech)
Mumbai
2018.11 - Current
- 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
- To align and harmonize with dissolution development group in Belgium (Beerse), United States and other related DPDS and JSC sites to perform comparability/similarity studies for LCM projects
- Responsible for the preparation and review of test methods, In-process and FP Specifications, technical documents, protocols, reports and SOP’s whenever required
- Conduct data analysis, identifying trends in complex datasets, and recommending improvements based on findings
- Coordinate with contract laboratories and CROs, ensuring project timelines and quality standards are met
- Maintain compliance with regulatory updates, tracking pharmacopoeia monograph changes and ensuring effective knowledge sharing with the team
- Responsible for data review and management for IO, OQ and PQ of instruments
- 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
- Responsible for performing investigations and determination of root cause
Scientist R1B
Dr. Reddy’s Laboratories Ltd
Hyderabad
2014.01 - 2018.10
- Acted as a senior team member and led efforts to map successful filing
- Undertaking projects and execution of analytical method development activities for Assay, Dissolution (Multimedia dissolutions, Discriminatory dissolution methods), Related Substances, Particle size distribution, PXRD, Blend assay, content of uniformity, Uniformity of dosage unit and Residual Solvents for Solid oral formulations (Oncology), semi-solids, Injections and Suspensions
- Executed comprehensive forced degradation studies, ensuring method robustness and stability
- Providing analytical support for working standard qualification for different tests with all necessary documentation
- Preparing technical documents of the in-house developed analytical methods, standard testing procedures and specifications for routine use by QC personnel as well as Managing post authorization activities: revisions, change control for approved methods, validation protocols & reports, etc
- Leading, training & monitoring the team to ensure efficiency in operations; providing a stimulating environment to teams to increase scientific exchange & knowledge transfer
- Coordinating with cross functional departments such as Product Development Department, Quality Assurance and Regulatory Affairs
Executive
TEVAPHARM India Pvt Ltd
Goa
2011.10 - 2013.12
- Performed Method Development, Method Validation, Method Transfer for Related Substances, Assay, Dissolution and particle size distribution of various dosage forms like oral solids, solutions, suspensions, Parenteral dosage forms
- Preparation and review of test method, specifications, method development report, method validation protocol & report for Canada, Germany, France, Israel and Japan market
- Troubleshooting and investigative testing for Assay, Related substances and Dissolution methods
- Managed API-excipient compatibility studies and reverse engineering for innovator formulations
Executive
Micro Labs Pvt Ltd
Bengaluru
2009.10 - 2011.10
- Performed Method Development, Method Validation, Method Transfer for Related Substances, Assay and Dissolution of various dosage forms like oral solids, Suspensions, Parenteral dosage forms
- Preparation of test method, specifications, method development report, method validation protocol & report
- Determination of Various grades of Excipients for Innovators formulation using various techniques such as DSC and HPLC with RI or ELSD Detectors
- Conducted analytical studies of new formulated product for ANDA filing like API characterization, API method verification
- Ensured compliance with cGMP/cGLP during analytical studies and documentation preparation
Education
M. Pharm -
Nagpur University
Nagpur, India 2007.09 - 2009.08
B. Pharm -
Dr Babasaheb Ambedkar Marathwada University
Aurangabad, India 2003.08 - 2007.08
HSC -
KKW College
Nashik, India 2002.05 - 2003.05
Skills
Analytical Techniques: HPLC (Waters, Agilent, Shimadzu), UPLC, GC (Agilent, Shimadzu), UV-Vis Spectrophotometry, LC-MS, FTIR, PXRD, DSC, TGA
Data Analysis & Software: Empower, Electronic Labnotebook, Minitab 18, Tableau, Power BI, Python, SQL
Regulatory Knowledge: ICH Guidelines, USFDA, EMA, Global Health Authorities (Brazil, Japan, China)
Project Management: Cross-functional Team Collaboration, Project Coordination, Analytical Support for Life Cycle Management (LCM)
Quality Systems & Compliance: cGMP, OOS/OOT Investigation, CAPA, Deviation Handling
Instrument Handled
- HPLC and UPLC (Waters, Agilent, Shimadzu; Software: Empower, Chromolene)
- Agilent 7890 GC with TCD and FID detector (Software: Empower)
- LC/MS, ICP, FT/IR, UV-Vis. Spectrophotometer (Shimadzu)
- Dissolution Test Apparatus (Distek, Labindia, Electrolab and Varian-UV)
- Particle size analyser (Malvern 2000 and 3000)
- Viscometer (Brookfield) and Osmometer
- DSC, TGA, and PXRD, KF Autotitrator (Metrohm)
- Disintegration Tester, Hardness Tester
Key Achievements
- Led the identification of dissolution drop during aging studies, contributing to the optimization of product formulations
- Led the development and validation of an innovative discriminatory dissolution test for oncology formulations, enabling improved product performance during stability studies
- Spearheaded a cross-functional team that successfully completed method transfer for a critical API, ensuring compliance with global health authorities, resulting in market authorization across multiple regions (US, EU, and Japan)
- Played a pivotal role in the identification of an unknown impurity, preventing potential product failure and ensuring patient safety
Extracurricular Activities
Participated in State level Pharmacy Cricket Cup, Bharati Vidyapith, Pune, 2004-2007
Conferences & Seminars
- Poster presentation competition on Green Chemistry, Institute of Pharmaceutical Education and Research, Wardha, 12/01/07
- 60th Indian Pharmaceutical Congress 2008, Delhi, 12/01/08
- AICTE Sponsored National Symposium on Chromatography- An Important Tool for Herbal Pharmaceutical Industry, Institute of Pharmaceutical Education and Research, Wardha, 01/01/09
Timeline
Sr. Scientist
Janssen Pharmaceuticals (on Payroll of GVW Tech)
2018.11 - Current
Scientist R1B
Dr. Reddy’s Laboratories Ltd
2014.01 - 2018.10
Executive
TEVAPHARM India Pvt Ltd
2011.10 - 2013.12
Executive
Micro Labs Pvt Ltd
2009.10 - 2011.10
M. Pharm -
Nagpur University
2007.09 - 2009.08
B. Pharm -
Dr Babasaheb Ambedkar Marathwada University
2003.08 - 2007.08
HSC -
KKW College
2002.05 - 2003.05