Seasoned pharmaceutical leader with more than 22 years of pharmaceutical industry experience in analytical development and quality control including more than 15 years of supervisory experience. Advanced skills and knowledge in product development, CMC (Chemistry, Manufacturing & Controls), technology transfer, quality management, regulatory & compliance and product launches. Successfully lead cross-functional teams with strong leadership and technical oversight supporting internal and external projects.Extensive experience in several areas including analytical method development, method transfer, method optimization, troubleshooting for different dosage forms like solids, liquids, sterile injectables, biologics and lipids dosage forms.Work with business, project management and regulatory departments to determine project prioritization and timings.Maintain Data integrity and ensure compliance with company SOP, USP/ Ph Eur, FDA and cGMP.Working with different groups within an organization includes formulation, quality assurance, regulatory, manufacturing to solve both technical and process related issues.Built and led cross functional teams through active team work to meet objective and timelines. Leads complex investigations into internal and external facilities.Provides technical expertise of analytical related issues and gave strategic input into department structure. Develop strong relationships with different vendors and service providers. Provide support to regulatory department in analytical section of CMC sections of regulatory submissions. Proven expertise and experience in writing and reviewing SOP, Investigations, Deviations, CAPAs, root-cause analysis change controls and instrument calibration protocols. Orchestrated setting up Quality control laboratory with qualification of lab equipment. Serve as a primary point of contact for general and product specific (PAI) regulatory inspections.