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Navi Mumbai
RAVI KALGUTKAR

RAVI KALGUTKAR

Manager - Analytical development and validation

Pharmaceutical / Bio-tech

Navi Mumbai, Thane District

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About RAVI KALGUTKAR:

 

Experience

  • Demonstrating 17 years of expertise in Analytical Development, Method Validation, Method transfer and Team Management in the pharmaceutical & chemical industry, showcasing a strong foundation in these areas.
  • Actively contributing as the Deputy General Manager at Respect Labs LLP, Mahape, Navi Mumbai, fostering exponential growth in the industry.
  • Combine customer-focused mindset with strong acumen to achieve timely delivery of high-quality products; acknowledged for reducing supplier / customer turnaround and bringing in revenue by ensuring optimum utilization of resources 
  • Comprehensive experience in analytical method development within the pharmaceutical industry, specializing in Chemical Raw Materials, Intermediates and Active Pharmaceutical Ingredients (APIs).
  • Proven proficiency in developing and validating analytical methods for a wide range of chemical raw materials and intermediates, ensuring high-quality standards and compliance with industry regulations.
  • Expertise in the analytical development and validation of active pharmaceutical ingredients, contributing to the successful formulation and quality assurance of pharmaceutical products.
  • In-depth knowledge of regulatory requirements and quality control procedures, ensuring all analytical methods meet stringent industry standards and guidelines.
  • Skilled in utilizing advanced analytical techniques such as HPLC, GC, GCMS, LC-MS, FTIR, UV-Vis and NMR for method development, validation and troubleshooting. 
  • Demonstrated ability to optimize and troubleshoot analytical methods, improving accuracy, precision, and reliability of results.
  • Experience in collaborating with cross-functional teams including R&D, QA/QC, and production to support the development and commercialization of pharmaceutical products.
  • Proficient in preparing comprehensive technical documentation and reports, including method development protocols, validation reports, and standard operating procedures (SOPs).
  • Strong project management skills with the ability to lead and coordinate multiple projects simultaneously, ensuring timely completion and adherence to project goals.
  • Commitment to continuous improvement and innovation in analytical methods, staying updated with the latest advancements and technologies in the field.
  • Worked as a team member to implement and comply with regulatory requirement of USFDA, TGA-Australia, TPD-Canada, MCA (MHRA-UK) MCC- South Africa & WHO-GMP 

Education

  • Ph.D. in Chemistry, Gitam University, Visakhapatnam, India, 2017
  • M.Sc. in Organic Chemistry, Mumbai University, Mumbai, India, 2007
  • B.Sc. in Chemistry, Mumbai University, Mumbai, India, 2004

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