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Milind Kulkarni

Partner

About Milind Kulkarni


Milind Kulkarni is an Engineering and projects expert with more than 30 years experience and held leadership positions in Pharmaceutical industry. During the professional tenure he partnered with organization leadership to advance the organization objectives by means of  up gradation and expansion of projects considering compliance matters to assure timely launch of new products and increased product revenues.

As part of his professional assignments he covered the complete lifecycle of the product from the initial conceptualization of idea to commissioning and qualification of commercial manufacturing facilities (Manufacturing, Quality Control and associated utilities) through optimization of operations. This includes application of manufacturing experience into facility design, based on a combination and in-depth knowledge within process, quality, facility, automation and physical project delivery. All the assignments have concentrated on compliance programs, specializing in the areas of manufacturing operations, facilities (water systems, HVAC, etc.), engineering, calibration, maintenance, and related programs in the regulated industry.

  • Making the right manufacturing decisions based on thorough analysis of a broad range of options

  • Establishing compliant, cost-effective development and manufacturing facilities

  • Project management ensuring successful project execution on time and within budget

  • Revamps of running facilities, where downtime has to be minimal

  • Supporting flexible, fast and modular manufacturing

  • Safe and controlled introduction of new technologies

  • Preparing for seamless audits

  • Applying industry standards for qualification and validation activities

  • Strategies applying the right level of automation

  • Implementing effective quality control systems

  • Implementing product quality focused control strategies

  • Supporting cost-effective and compliant daily operation

HIGHLIGHTS OF COMPLIANCE PROJECTS:

Concept to Commissioning of green field, brown field and expansion of Pharmaceutical manufacturing facilities in compliance with regulatory requirements at Bayer (I) Limited, Orchid Chemicals and pharmaceutical Limited, Emcure Pharmaceutical Limited, Lupin laboratories and Dr.Reddy's Laboratories Limited. These include:

  • Concept to Commissioning of API Plants (Sterile and Non-Sterile)

  • Pharmaceutical Utilities - HVAC, Water Systems (Potable Water, Purified Water and Water For Injection), Pure Steam, and Air Systems (Compressed and Nitrogen gas)

  • Multipurpose Manufacturing Plants considering contamination risk elements

  • Spray dryers ( close and open circuit )

  • Waste water treatment (Zero Liquid discharge plant) First of its type through electro oxidation / Coagulation methodology

  • Utilities including very low temperature.

  • Customized and Specialized facilities for Cryogenic reactions and Hazardous reactions  for API manufacturing

  • Best in Class Solvent Recovery plants - Multipurpose solvent recovery blocks, Exclusive systems for difficult solvent recovery system and Solvent abatement ( vent solvent recovery)

  • R& D facility equipped with Pilot manufacturing facility for API


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