Mahendrasingh Chavan
Project Lead (Formulation Development, Technolgy Transfer, Project Management) @Crescent Pharma Ltd
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WORK HISTORY
Project Lead (Formulation Development, Technolgy Transfer, Project Management) @Crescent Pharma Ltd
Mumbai, IN
1.Managing technical transfers to contract manufacturing organizations. This includes Technical Transfers of products from Development, internal sites and from CMO to CMO 2.Driving process capability analysis to assess process robustness. Identifying and executing process robustness improvement projects, where required.3.Examine the current operations in other markets such as the US, Canada, and the EU. 4.Providing technical guidance in the understanding of root causes for out of trend or out of specification results or deviations for OSD and liquid manufacturing processes. 5.Co-ordinate with cross functional team (Regulatory, commercial, QA) and external stake holders (CMO, Regulatory agencies, for the projects progress. 6.Incorporate innovative technology into the system. 7.Ensure that CDMO operations are managed and executed. 8.Visiting or review of contract manufacturing site for projects overview, strategy and improvement. 9.Examine the current operations in other markets such as the US, Canada, and the EU. 10.The assessment and management of projects culminates in commercialization. 11.During TT at supplier sites, ensure that all necessary troubleshooting is performed. 12.Maintain cGxP in compliance at all work levels as per current EU guidance and internal standards laid down by Crescent Pharma13.Preparation of SOP, Work instructions, Policies as per cGxP and Crescent internal Standards.
EDUCATION
Rashtrasant Tukadoji Maharaj Nagpur University
Bachelor of Pharmacy - BPharm, Ist class
Indian Institute of Management, Indore
Certificate Programme in Project Management, Project Management
Rashtrasant Tukadoji Maharaj Nagpur University
Master's degree, Pharmaceutics and Drug Design, Distinction
Directorate of Technical Education
Diploma in Pharmacy, Distinction
Nutan vidya mandir, parbhani
Secondary school certificate, Ist class
Indira Gandhi National University
Master of Business Administration - MBA, Operations management
Aadarsh college, Hingoli
High School Diploma, Science
ABOUT MAHENDRASINGH CHAVAN
With over 13 years of experience in formulation development and project management in the…
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