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Work Background
Dr.Hotha’s Life Sciences LLCPresident
Sep. 2024United States, BostonLeading CDMO CMO management
VeranovaGlobal Vice President – Lab Operations
Jun. 2022 - Aug. 2024Devens, Massachusetts, United States•Lead end-to-end lab operations and support preclinical to commercial development across Veranova sites in the US, UK, India, and China, Delivered technical advancements and established a Center of Excellence within R&D, leveraging cutting-edge practices, digital tools, and technologies. Collaborate with top pharma and biotech companies to meet their needs, build successful brands, and drive technical development. •Manage international teams of >70+ scientists, and a CapEx budget across Cambridge (UK), Edinburgh (UK), Devens (US), Yantai (China), and West Deptford (US) analytical sites. Built a team of technical experts to support the AR&D/QC portfolio and deliver exceptional value to stakeholders. Fostered a culture of innovation and excellence and developed staff through mentoring, coaching, and providing opportunities for skill advancement. •Supported several biotech clients supporting DMFs , INDs, NDAs, and ANDAs and the commercialization of their compounds to enhance regulatory compliance and market readiness.
•Established a ‘fast-to-clinic’ approach and developed new technical capabilities in ADCs, oligonucleotides, peptides, and other generic drugs. •Executed an analytical lab footprint with advanced instrumentation to support diverse drug development projects while ensuring high quality standards and regulatory compliance through QbD methodologies.
Johnson MattheyGlobal Director-Lab Operations
Nov. 2020 - Jun. 2022United States•Lead end-to-end lab operations and support preclinical to commercial development across Veranova sites in the US, UK, India, and China, Delivered technical advancements and established a Center of Excellence within R&D, leveraging cutting-edge practices, digital tools, and technologies. Collaborate with top pharma and biotech companies to meet their needs, build successful brands, and drive technical development. •Manage international teams of >70+ scientists, and a CapEx budget across Cambridge (UK), Edinburgh (UK), Devens (US), Yantai (China), and West Deptford (US) analytical sites. Built a team of technical experts to support the AR&D/QC portfolio and deliver exceptional value to stakeholders. Fostered a culture of innovation and excellence and developed staff through mentoring, coaching, and providing opportunities for skill advancement. •Supported several biotech clients supporting DMFs , INDs, NDAs, and ANDAs and the commercialization of their compounds to enhance regulatory compliance and market readiness.
•Established a ‘fast-to-clinic’ approach and developed new technical capabilities in ADCs, oligonucleotides, peptides, and other generic drugs. •Executed an analytical lab footprint with advanced instrumentation to support diverse drug development projects while ensuring high quality standards and regulatory compliance through QbD methodologies.
LupinHead of Analytical Research & Development and Quality Control
Jan. 2012 - Jan. 2020Somerset, New Jersey, United States• Led AR&D and QC operations for CMC sections in DMFs, NDAs, ANDAs, and INDs for Lupin sites across the Americas and India. Maintained responsibility for all site tech transfers, investigations, FDA inspections, and the quality of lab operations. Developed technologies and capabilities for deformulations, extractables and leachables, and nitrosamine impurities, addressing complex analysis turnaround issues and providing immediate support for product submissions. • Managed 4 direct reports, provided strategic leadership to a team of 35 R&D scientists, and directed an annual budget responsibility of up to $30M. Drove research and development and provided technical oversight to deliver new complex drug products successfully. • Restructured the organization and led the strategic execution of KPIs and performance metrics to reduce project backlogs by 70% within six months. Established systems for FDA deficiencies and first-to-file projects to complete three critical projects in 10 months. Spearheaded operational excellence initiatives, resulting in improved quality events and reduced lab incidents, and successfully managed over 100 backlog deviations, investigations, and CAPAs.
• Contributed to 96 ANDA/DMF submissions, reviews, and approvals over eight years and successfully completed four FDA inspections and more than 10 product-specific inspections. Delivered a new $16M, state-of-the-art 10,000 sq. ft. analytical and QC facility on time and within budget, which drove advanced R&D / Commercial activities and enhanced compliance with regulatory standards.
Dr. Reddy's LaboratoriesDeputy Manager
Jan. 2006 - Jan. 2012Hyderabad, Telangana, India• Led analytical and bioanalytical research, development, and validation for drug substances and products, encompassing an annual budget responsibility of up to $35M. Successfully managed and delivered over 30 projects, including all responses to FDA deficiency inquiries.
• Managed 4 direct reports and a team of 30 CDROs and CDMOs for preclinical/clinical studies execution and spearheaded the development of all technical teams and analytical facilities. Implemented on-the-job training for Analysts and Junior Managers in Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). • Headed the development of 100+ bioanalytical and clinical studies for generic products, collaborated with CROs for pilot and pivotal studies, and ensuring on-time submissions. • Executed analytical quality inspection outsourcing with global CROs/CDMOs and achieved positive outcomes in new product launches, API and excipient qualifications, and sample batch submissions. Provided QC subject matter expertise across internal and external testing sites and guided preparations for all product-related and cGMP inspections. • Established a 10,000 sq. ft. in-house bioanalytical facility equipped with high-end LC-MS, LC-MS/MS, and HPLCS systems. Guided the in-house teams through hundreds of studies, saved $10M+ over five years, and enabled complex method transfers for fast-track turnarounds.
Cadila Pharmaceuticals LimitedResearch Associate
Jan. 2004 - Jan. 2006Ahmedabad, Gujarat, India
AUROBINDO PHARMA LTDResearch Associate
Jan. 2003 - Jan. 2004Hyderabad, Telangana, India
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