Subhadip Roy
Experienced Manager – Extractables & Leachables (E&L) with over 15 years of expertise in pharmaceutical analytical development and regulatory compliance
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About
Experienced Manager – Extractables & Leachables (E&L) with over 15 years of expertise in pharmaceutical analytical development and regulatory compliance. Specialized in E&L studies, Delamination study, Reverse Engineering of Reference product, elemental impurities, injectable, inhalation, and drug–device combination products. Strong background in ICH Q3D, USFDA/EMA regulatory support, CRO coordination, laboratory setup, and team leadership.
Experience
Senior Manager (SS-1) – Extractables & Leachables - Aurobindo Pharma Limited - Hyderabad, India
(2024-11)
- Review and approve E&L protocols, studyreports, and risk assessment documents.
- Lead planning, coordination, and executionofExtractables & Leachables studies with multiple CROs.
- Drive new in-house E&L laboratory setupandcapability expansion.
- Support regulatory submissions and respondtohealth authority queries.
- Collaborate with Quality, Regulatory Affairs,and R&D teams.
Senior Scientist – E&L & Analytical Development - Sandoz Development Centre - Hyderabad, India
(2020-09 - 2024-11)
- Executed delamination, migration, and reverse engineering studies.
- Planned and reviewed E&L studies for injectable, inhalation, and drug–device combination products.
- Designed studies for VOCs, SVOCs, NVOCs, elemental and ionic impurities.
- Coordinated with global CROs and provided technical oversight.
- Mentored team members and supported regulatory authority responses.
Research Scientist – Analytical Development - Dr. Reddy's Laboratories - Hyderabad, India
(2017-12 - 2020-09)
- Developed and validated analytical methods for elemental and ionic impurities.
- Conducted E&L studies using LC-MS, GC-MS, ICP-MS, and IC.
- Reviewed analytical data, SOPs, and qualification documents (IQ/OQ/PQ).
- Supported method transfer and new laboratory setup.
Senior Research Scientist - Iqgen-X Pharma Pvt. Ltd. - Navi Mumbai, India
(2017-05 - 2017-12)
- Developed analytical methods for assay, related substances, and dissolution.
- Prepared and reviewed SOPs, specifications, and validation protocols.
- Supported analytical laboratory establishment.
Research Scientist - Wockhardt Research Centre - Aurangabad, India
(2013-03 - 2017-04)
- Led elemental impurity analysis using ICP-MS, ICP-OES, and AAS.
- Performed routine analysis using HPLC, IC, XRD, DSC, and TGA.
- Supported regulatory audits and troubleshooting of advanced instruments.
Officer–Analytical Development - Mylan Laboratories Ltd. - Hyderabad, India
(2010-12 - 2013-03)
- Conducted elemental impurity analysis and wet chemistry testing.
- Supported regulatory responses, calibration, and method transfer.
- Worked with LIMS and SDMS systems.
Education
M.Pharmacy - Pharmaceutical Analysis & Quality Assurance - Biju Patnaik University of Technology, Odisha
Bachelor in Pharmacy - Pharmacy - Biju Patnaik University of Technology, Odisha
