Karthik Ramani
Associate Vice President/Portfolio Lead, Biologics Process and Product Development (insulin analogues and monoclonal antibodies, DS/DP, development and life cycle management), at Biocon Biologics Limited
- Role
- Principal Scientific Manager Associate Director at Biocon
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Karthik Ramani
Experienced biotechnology professional (CMC) focusing on process and product development of biologicals (biosimilar and novel monoclonal antibodies, insulin and analogues); Experienced, working at the interface of R&D, IP, Manufacturing, Technical operations, Quality, Regulatory, Supply Chain, Program Management and Business Units including Commercial, Strategy and Market Access; Integral part of the core team involved in getting approvals for biosimilar Trastuzamab and PEG-GCSF with USFDA and EMA, biosimilar insulin Glargine approvals with USFDA, PMDA (Japan) and EMA (EU), biosimilar insulin Aspart (EU); passionate about public health policies impacting affordability and accessibility of Healthcare solutions
Experience
Principal Scientific Manager Associate Director
Apr 2013 — Present · Bangalore, IN
Group Leader-Novel and Biosimilars-Biologics Formulation and Associated Process Development\\\\n\\\\nCMC lead for recombinant human insulin program: Provide technical leadership for the program in US/EU/Japan/Emerging markets and work closely with global partners, program management and business development teams to align product development requirements
Education
University at Buffalo
Ph.D., Pharmaceutical Sciences
1999 — 2005
Birla Institute of Technology and Science, Pilani
Bachelors/Masters, Pharmacy/Biosciences
1994 — 1999
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