Hardik Modi (M.Pharm, Ms)
About Hardik Modi (M.Pharm, Ms)
Hardik Modi is a Senior Manager and Senior Principal Process Engineer at Bristol Myers Squibb with extensive experience in technology transfer and process validation in the biopharma sector.
Company
Hardik Modi currently works at Bristol Myers Squibb as a Senior Manager, Senior Principal Process Engineer, LCM, Global MSAT. Bristol Myers Squibb is a global biopharmaceutical company known for its innovative medicines and commitment to addressing unmet medical needs in serious diseases.
Title
At Bristol Myers Squibb, Hardik Modi holds the position of Senior Manager, Senior Principal Process Engineer in the Lifecycle Management (LCM) and Global Manufacturing Science and Technology (MSAT) departments. His role involves leading process engineering projects and ensuring the smooth technology transfer and validation processes within the company.
Professional Background
Hardik Modi has extensive experience in the pharmaceutical and biopharmaceutical industries. He previously worked at ICU Medical as a Sr. Process Engineer- Tech Transfer Lead and Senior Validation Engineer. Hardik has also held roles at Allergan and Hyde Engineering + Consulting, where he contributed to process design and cleaning validation. Additionally, he worked for Genentech and Vapi Care Pharma in various validation roles, continuously enhancing his expertise in equipment qualification and process development.
Education and Expertise
Hardik Modi holds a Master of Science in Pharmaceutical Manufacturing from Stevens Institute of Technology and a Master of Pharmacy from Gujarat Technological University. He also achieved a Lean Six Sigma Green Belt certification from Purdue University. His academic background is complemented by a Bachelor of Pharmacy from Gujarat University. Hardik's expertise includes technology transfer, process development, cleaning validation, and comprehensive knowledge of global regulatory regulations.
Achievements and Specializations
Throughout his career, Hardik Modi has specialized in equipment qualification and cleaning validation within pharmaceutical processes. He possesses extensive experience in technology transfer, particularly in the biopharma sector, and has in-depth knowledge of global regulatory standards including FDA, CDC, MHRA, HPRA, and KFDA. Hardik is known for his pragmatic leadership style and effective project management skills in pharmaceutical and biopharma environments.