Founder Biography
Manish Bhatkar is an experienced pharma professional, diligent in his core functional area (pharmaceutical technical operations) and committed to the profession. Before founding RedLotus in 2016, in his 25 years of service, he has discharged executive as well as leadership responsibilities in the areas of design & development, manufacturing, qualification & validation, operations management, quality assurance, quality management, audits & compliance, regulatory affairs, technology transfer, project management, and technical consulting. He has worked in R&D, API's, formulations and technical consulting environments and has demonstrated equivalent capabilities in managing manufacturing, technical as well as quality operations with ease.
He was instrumental in establishing and growing the validations & GMP compliance services business vertical for a German pharmaceutical engineering house Pharmaplan GmbH (Now, NNE Pharmaplan) in India. As head of the Dabur Oncology Plc. Operations, in his 5 years tenure in UK, he single handedly lead the efforts in resolving complex technological, regulatory and GMP compliance issues (including USFDA warning letter) that resulted in making commercial manufacturing and product supplies possible from the site. As head of Lupin Limited' Technical Services, he lead the mission to transform the quality mindset and culture at their Goa manufacturing facility for meeting the exceptional and extreme Japanese quality requirements/ expectations. International experience of working in different geographies and work cultures helped him further strengthen his technical as well as leadership skills and capabilities.
His main area of expertise is aseptic processing & areas of interests are sterility assurance, manufacturing technology, process validation, failure investigations, trouble-shooting, continuous improvement and resolution of complex technical/ regulatory/ GMP issues. Additionally, he has lead team of experts in preparing the regulatory filings, facing GMP inspections / audits and responding to the inspectional observations of various regulatory agencies, such as WHO, ISO, USFDA, UK-MHRA, ANVISA, ENVIMA, Russia, Romania, Hungary, Germany etc.
Manish has worked with medium to large, well respected pharmaceutical products manufacturing and services organizations like Dr. Reddy's Laboratories Ltd., Lupin Limited, Dabur Oncology Plc. UK, Pharmaplan (India) Ltd., and Zydus Cadila. He has been involved in many projects from concept design to successful delivery of commercial product to the continuous improvement phases and also led organization(s) efforts and teams in managing and resolving regulatory challenges like regulatory review/ inspectional observations, warning letters and consent decree.
He is a postgraduate in Pharmaceutical Sciences and an active member of professional associations like ISPE, PDA, and IPA. In addition to being a pharma-professional, he is also a regular speaker in industry & academia seminars/ conferences and a trainer on the topics like qualification and validation, process validation, quality systems etc. He is well travelled and has also worked on short and long international assignments particularly in the UK, USA & Japan.