Himanshu Jamdade
Specialist @ Dr. Reddy\'s Laboratories | Mass Spectrometry, Extractable and Leachable
- Role
- Specialist at Dr. Reddy's Laboratories
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Himanshu Jamdade
As a Specialist at Dr. Reddy\'s Laboratories, I bring over 10 years of experience in analytical development, specializing in Extractables & Leachables (E&L) and Nitrosamines. I lead the development and validation of LC-MS/HRMS-based methods, enabling regulatory compliance and ensuring audit readiness for global agencies such as USFDA, EMA, and MHRA. My work involves collaborating with cross-functional teams in formulation, regulatory, and quality assurance to drive innovation and compliance in pharmaceutical R&D. Through prior roles as Associate Scientist at Sandoz and Scientist at Dr. Reddy\'s, I have honed competencies in mass spectrometry, analytical method validation, and regulatory submissions. By mentoring junior analysts and representing analytical teams in technical review meetings, I contribute to fostering a culture of technical excellence. My mission is to advance patient safety and pharmaceutical innovation by shaping robust analytical frameworks and delivering high-quality regulatory solutions.
Experience
Specialist
Mar 2025 — Present
Lead development and validation of LC-MS/HRMS-based methods for Extractables & Leachables and Nitrosamines in various dosage forms.Strategically oversee regulatory submissions and ensure audit readiness (USFDA, EMA, MHRA).Drive cross-functional initiatives with formulation, regulatory, and QA teams.Mentor and train junior analysts and research associates.Represent analytical team in global regulatory and technical review meetings.
Education
Pad. Dr. D. Y. Patil IPSR, Pimpri, Pune
Bachelor's Degree, Pharmacy
2009 — 2013
R C Patel Institute of Pharmaceutical Education and Research
Master's Degree, Pharmacy
2013 — 2015
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