Mandar Gaikwad

About Mandar Gaikwad

High energy, experienced pharmaceutical executive with over 20 years’ experience in Analytical Lifecycle Development of drugs and pharmaceuticals from early stage development through commercialization. Strong capabilities across multiple functions; able to set strategy, execute and deliver superior results• Innovative, methodical problem solver, utilizing advanced analytics to evaluate technologies and leverage efficiencies for continual gains in quality, productivity, and profitability.• Broad knowledge of analytical methodologies and instruments, technical transfer methodology, cGMP, validation processes and control in compliance to FDA, ISO, QRM, and other regulatory requirements.• Key contributor to investigation and reliability initiatives. Knowledge of current industry validation strategies and prior experience working with R&D bringing products to market. • Engaging communicator with outstanding ability to collaborate and build consensus upward, downward, and across diverse groups. Industry leader who builds and inspires product innovation teams of multi-disciplinary business and technical stakeholders with the common goal of advancing health care technology.Specialties: Strategy | Technology Transfer | Method Development | Quality Assurance |Testing Method | Validation | Regulatory Compliance | Audits | CAPA, QIR and OOS Investigations | Stability Study and Protocols |Method Validation | Protocol and Study Analysis| Impacts Analysis | Change Control |Instrument Calibration | Team Management CONTACT INFORMATION: m••••••••@outlook.com:+91••••••••70

Experience

1. Senior Scientist Group Lead

   Lupin

   Jan 2002 — Present · Pune, IN

   Responsible for analytical development to support research and development, tech transfer and commercialization of drug substance and drug product processes, as well as oversight of batch testing/release and regulatory document contribution through managerial and individual input.• Develop and expand the R&D expertise through recruitment, retention, training and personal development; leading a team of 12 scientists in routine analysis, method development and analytical method transfer related to API.• Support drug substance process development including characterization of starting materials, intermediates, and final API. Execute several analytical techniques, efficiency improvement, cost rationalization for projects. • Conduct and manage development projects and ensures the successful tech transfer of new products and processes to production per timelines and budget