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Harish Pimplaskar
Vice President, CMC at Milestone Pharmaceuticals, Inc.
Professional Background
Harish Pimplaskar boasts an impressive career in the pharmaceutical industry, spanning over 25 years with a keen focus on pharmaceutical development and a profound understanding of regulatory procedures. His professional journey can be characterized by leadership roles, having spent the last 15 years in director-level positions and above, honing his expertise in all facets of drug substance (API) and drug product development. With a strong foundation in Chemistry, Manufacturing, and Controls (CMC), he has effectively contributed to the success of multiple pharmaceutical organizations, driving innovative solutions and strategic decisions that align with market needs and regulatory standards.
Currently, Harish serves as the Vice President of CMC at Milestone Pharmaceuticals, Inc., where he leverages his deep-seated knowledge to oversee the complexities of CMC processes and ensure compliance with Good Manufacturing Practices (GMP) and other regulatory frameworks. Throughout his career, he has held significant roles in prestigious companies, including Executive Director of CMC and Pharmaceutical Development at Axsome Therapeutics, Inc., and Senior Director at Lundbeck NA Ltd., among others. His diverse experience across both brick-and-mortar establishments and virtual companies equips him with a versatile understanding of industry challenges and opportunities.
Education and Achievements
Harish's educational background is as robust as his professional experience. He holds a Master's degree in Pharmaceutics from the University of Rhode Island, which provides him with a strong scientific foundation and technical proficiency essential for drug development. Further enhancing his business acumen, he also earned an MBA in Business Administration from Averett University. His academic journey began with a Bachelor's degree in Pharmacy from Savitribai Phule Pune University, where he laid the groundwork for his career in pharmaceuticals.
Throughout his career, Harish has demonstrated a remarkable ability to navigate the complexities of regulatory requirements, evidenced by his successful history of securing approvals for three New Drug Applications (NDAs). His extensive knowledge of Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and regulations from the FDA, Center for Drug Evaluation and Research (CDER), and the European Medicines Agency (EMA) stands testament to his dedication and commitment to the pharmaceutical field.
Achievements
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Successful NDA Approvals: Harish has a proven track record with three successful NDA approvals, highlighting his competence in regulatory submissions and understanding of complex drug approval processes.
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Leadership and Management: His experience at various renowned organizations in senior management roles has refined his leadership capabilities, allowing him to build and motivate high-performing teams dedicated to pharmaceutical development.
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Expertise in CMC Compliance: Harish has established a solid reputation for his expertise in vendor selection, audits, and for-cause investigations, ensuring adherence to CMC standards that are vital for the seamless progress of pharmaceutical projects.
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Strong Communication Skills: With effective written and oral communication skills, he has contributed to various marketing strategies and business research initiatives that propelled the growth of organizations he worked with.
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Problem-Solving Abilities: Harish's strong analytical skills enable him to approach complex issues with a solution-oriented mindset, consistently developing innovative approaches to overcome obstacles in drug development.
Conclusion
In summary, Harish Pimplaskar stands out as a seasoned professional in the pharmaceutical industry, combining profound scientific knowledge with strategic business insights. His leadership across various prestigious organizations and his commitment to regulatory excellence showcases his vital role in advancing pharmaceutical development and compliance. With a solid educational foundation and an impressive history of achievements, Harish remains dedicated to contributing positively to the ever-evolving landscape of pharmaceutical sciences.
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