ROHIT R. WAKODKAR
Pune
Summary
Ph.D. in Chemistry with over 10+ years of experience in pharmaceutical analytical R&D, focusing on method development, validation, transfer, and stability studies. Proven leadership in managing teams of up to 8 scientists in GxP-regulated environments. Expertise in HPLC, UPLC, GC, LC-MS, and GC-MS for APIs, intermediates, and pharmaceutical products. Skilled in GMP documentation, OOS/OOT investigations, QMS, and data integrity, with additional training in CSV/CSA, GAMP 5, and 21 CFR Part 11 compliance.
Overview
1
1
Certification
17
17
years of professional experience
Work History
Sr. Scientist-1 (Team Leader)
HIKAL LIMITED
Pune, Maharashtra
11.2022 - Current
- Lead a team of 8 scientists supporting Analytical R&D activities in a GxP-regulated pharmaceutical environment.
- Manage laboratory work allocation, resource planning, project priorities and timelines for the team.
- Plan, coordinate and execute analytical development activities supporting pharmaceutical development and manufacturing.
- Develop, optimize and validate analytical methods for APIs, intermediates and pharmaceutical products using HPLC, UPLC, GC and LC-MS techniques.
- Led analytical activities for impurity profiling, degradation studies, forced degradation and stability evaluation, ensuring data integrity and compliance with regulatory standards.
- Led and supported OOS/OOT investigations, laboratory investigations, root-cause analysis and corrective/preventive actions to maintain quality standards and regulatory compliance.
- Conduct and support LC-MS-based degradation and impurity investigations.
- Prepare and review analytical protocols, method validation protocols/reports, specifications, STPs, stability reports and technical documentation.
- Support preparation and review of analytical documentation required for GMP and regulatory activities.
- Coordinate with QA, QC, Manufacturing, MS&T and other cross-functional teams for analytical development and technical activities.
- Troubleshoot analytical issues related to chromatographic performance, system suitability, peak shape, resolution, reproducibility and method performance.
- Train and mentor scientists on analytical techniques, method development, documentation and GMP requirements.
- Support analytical method transfer activities and provide technical support during method implementation.
- Support laboratory readiness for internal and external audits and inspections.
- Ensure compliance with GMP, data integrity and ALCOA+ principles in laboratory activities.
- Participate in change controls, deviations, CAPA and laboratory quality-system activities.
- Support analytical instrument qualification, calibration and lifecycle activities, including IQ/OQ/PQ-related activities.
- Work with computerized analytical systems and CDS platforms including Waters Empower 3, Agilent OpenLab, Shimadzu LabSolutions and Thermo Scientific Chromeleon.
- Support review of electronic records, audit trails, user access and computerized laboratory-system controls from a data-integrity perspective.
- Participate in CSV-related activities associated with PLC-based manufacturing equipment and computerized control systems, providing exposure to system assessment, GxP requirements, risk-based validation and validation documentation.
- Develop and optimize dissolution methods and support residual solvent analysis.
- Planned and executed analytical experiments aligned with product requirements and scientific understanding, utilising risk-based approaches to enhance development efficiency.
Associate Research Scientist – Analytical R&D
SAI LIFE SCIENCES LTD.
Hyderabad
06.2021 - 11.2022
- Contributed to analytical method development, optimisation, validation, and troubleshooting, ensuring robust and reliable methodologies.
- Prepared and reviewed analytical protocols, reports, and GMP documentation, ensuring compliance and quality standards.
- Coordinated analytical activities, enhancing team planning and execution efficiency.
- Supported analytical instrument calibration and qualification activities.
- Performed and supported forced degradation, impurity and stability studies.
- Supported residual solvent analysis and autosampler-based quantification.
- Supported analytical troubleshooting and resolution of laboratory issues.
- Worked on cleaning validation feasibility studies, protocols and reports.
- Participated in laboratory investigations, deviations, change controls and QMS activities.
- Ensured compliance with GMP and data-integrity requirements.
Assistant Manager – Analytical R&D, Lab Formulation
PULSE PHARMACEUTICALS PVT. LTD.
Hyderabad
11.2019 - 06.2021
- Managed analytical R&D activities to enhance laboratory formulation and advance pharmaceutical development.
- Developed, optimised and validated analytical methods for pharmaceutical products.
- Worked extensively on dissolution method development and analytical evaluation of topical dosage forms.
- Conducted forced degradation, impurity, stability, and residual solvent studies to ensure product safety and efficacy.
- Supported analytical method validation and documentation to maintain compliance with regulatory standards.
- Performed analytical troubleshooting and supported resolution of chromatographic issues.
- Prepared and reviewed analytical protocols, reports, specifications and GMP documentation.
- Coordinated laboratory activities, resource planning and team priorities.
- Supported compliance with GMP and data-integrity requirements.
- Supported analytical instrument calibration, qualification and maintenance activities.
- Participated in investigations, deviations, change controls and quality-system activities.
Executive – Analytical MS&T Laboratory
PFIZER HEALTHCARE INDIA PVT. LTD.
Aurangabad
05.2016 - 09.2019
- Executed analytical testing of APIs, intermediates and finished pharmaceutical products to ensure quality and compliance standards.
- Contributed to analytical method development, optimisation, and validation to enhance testing reliability and accuracy.
- Evaluated analytical method validation parameters including precision, accuracy, specificity, linearity, range and robustness.
- Performed HPLC-based analytical testing and troubleshooting.
- Supported analytical investigations and evaluation of atypical analytical results.
- Participated in IQ/OQ/PQ activities for new analytical instruments.
- Supported instrument calibration and qualification activities.
- Created and maintained GMP documentation, analytical reports, and technical records to support regulatory compliance and internal audits.
- Worked closely with QA and other functions to ensure GMP compliance.
- Participated in change control, deviation and laboratory investigation activities.
Executive – Analytical MS&T Laboratory
HOSPIRA HEALTHCARE INDIA PVT. LTD.
Aurangabad
06.2014 - 05.2016
- Conducted analytical testing of pharmaceutical products and intermediates to ensure quality and compliance.
- Assisted in analytical method development and forced degradation studies to enhance product stability assessments.
- Executed analytical instrument calibration, qualification, and troubleshooting to maintain operational integrity and reliability.
- Supported stability testing and analytical investigations.
- Prepared GMP documentation and analytical reports.
- Participated in change controls, deviations and laboratory investigations.
- Ensured compliance with GMP and laboratory procedures.
Jr. Executive – Analytical
ORCHID CHEMICALS & PHARMACEUTICALS LTD.
Aurangabad
10.2009 - 06.2014
- Conducted analytical testing of APIs and pharmaceutical materials, ensuring compliance with manufacturing standards.
- Hands-on experience with HPLC, GC and Karl Fischer instruments.
- Created and maintained analytical documentation in line with GMP requirements, supporting regulatory compliance.
- Assisted with troubleshooting of analytical processes in the laboratory. and instrument-related activities.
- Supported Process R&D analytical requirements.
- Participated in stability testing and analytical investigations.
- Assisted in the calibration of laboratory equipment to maintain precision. and routine maintenance activities for laboratory instruments.
Education
Ph.D. - Chemistry
Dr. Babasaheb Ambedkar Marathwada University
Aurangabad, Maharashtra01-2020
M.Sc. - Chemistry
Dr. Babasaheb Ambedkar Marathwada University
Aurangabad, Maharashtra01-2009
B.Sc. - Chemistry
Dr. Babasaheb Ambedkar Marathwada University
Aurangabad, Maharashtra01-2007
Skills
- Method development and validation
- Method transfer
- Impurity and degradation studies
- Stability assessment
- Analytical troubleshooting
- Pharmaceutical quality assurance
- Quality management system activities
- Inspection support
- Cross-functional collaboration
- Instrument qualification
- Degradation product monitoring
- Stability sample analysis
- Chromatography troubleshooting
- GMP documentation
- Laboratory investigations
- Audit trail review
- Data acquisition and management
- Electronic analytical records management
- User access controls
- Data integrity requirements
Certification
- Executive Programme in Computer System Validation (CSV) & Computer Software Assurance (CSA) – Pharma Connections
- ISO 13485
- ISO 9001:2015
- ISO 27001
- ISO 14001
Timeline
Sr. Scientist-1 (Team Leader)
HIKAL LIMITED
11.2022 - Current
Associate Research Scientist – Analytical R&D
SAI LIFE SCIENCES LTD.
06.2021 - 11.2022
Assistant Manager – Analytical R&D, Lab Formulation
PULSE PHARMACEUTICALS PVT. LTD.
11.2019 - 06.2021
Executive – Analytical MS&T Laboratory
PFIZER HEALTHCARE INDIA PVT. LTD.
05.2016 - 09.2019
Executive – Analytical MS&T Laboratory
HOSPIRA HEALTHCARE INDIA PVT. LTD.
06.2014 - 05.2016
Jr. Executive – Analytical
ORCHID CHEMICALS & PHARMACEUTICALS LTD.
10.2009 - 06.2014
Ph.D. - Chemistry
Dr. Babasaheb Ambedkar Marathwada University
M.Sc. - Chemistry
Dr. Babasaheb Ambedkar Marathwada University
B.Sc. - Chemistry
Dr. Babasaheb Ambedkar Marathwada University