Ravishankar Kasturi
Pune
Summary
Senior manufacturing operations leader with over 25 years in biologic's, biosimilars, and sterile injectables. Expertise in brownfield/greenfield expansions, tech transfer, scale-up, and regulatory compliance across multiple agencies. Currently leading Enzene Biosciences India Operations, managing a team of 300+ and driving biosimilar product development. Proven track record in strategic planning, crisis management, and revenue growth strategies.
Overview
26
26
years of professional experience
Work History
Senior Vice President, India Operations
Enzene Biosciences Ltd.
Pune
07.2020 - Current
- Reported to CEO while leading 300+ personnel across DS, DP, MSAT, WH, Engineering, and SCM.
- Oversaw GMP biologic's from small-scale to commercial production across five mammalian suites and two microbial suites.
- Managed global CDMO operations for DP, including vials, PFS, cartridges, and auto-injectors.
- Developed cGMP quality systems for markets including India, EMA, Turkey, Brazil, South Korea, and Australia.
- Led expansion projects in Pune and US facilities to scale production capacity.
- Achieved eight commercial biosimilar launches through effective project management.
- Directed CDMO projects from RFI to delivery, securing 98% on-time execution for NBEs.
- Optimized processes and costs while ensuring compliance across ten markets.
VP/Head of Biologic's Manufacturing & Expansions
Reliance Life Sciences
Navi Mumbai
04.2007 - 07.2020
- Delivered greenfield biologic's facility ahead of schedule and under budget for biosimilar production.
- Directed regulatory submissions and inspections, enabling successful commercial-scale launches.
- Guided change management initiatives to ensure seamless adoption of new business practices.
- Managed four 2500L SS, six 2000L SU mammalian, and two 1000L SS microbial reactors.
- Executed on-time, under-budget project management aligned with project road map.
- Spearheaded late-stage process development, enhancing product quality and efficiency.
- Developed long-range growth plans, boosting annual sales significantly.
- Led cross-functional teams to achieve project milestones efficiently.
Manager, Development & Manufacturing
Dr. Reddy’s Laboratories (DRL)
Hyderabad
08.2001 - 04.2007
- Led process development for Rituximab biosimilar, ensuring successful commercial launch.
- Directed microbial fermentation efforts for high-yield production of biologic's.
- Managed project timelines and resources across multiple product launches.
- Facilitated cross-functional teams to drive innovation and enhance product development.
Research Scientist
Uni-Sankyo Pvt. Ltd.
Hyderabad
08.1999 - 07.2001
- Developed submerged state fermentation process for Lactic Acid bacillus to enhance production efficiency.
- Optimized yield and cost for improved resource management.
- Conducted laboratory experiments to assess efficacy of various compounds across multiple applications.
- Created and implemented innovative research methods to investigate biological processes.
Education
Executive Management -
IIM
BangaloreBangalore
M.Tech - Biotechnology
Andhra University
VisakhapatnamVisakhapatnam
B.Pharm -
SCS College of Pharmacy
GulbargaGulbarga
Skills
- Biologics manufacturing and injectables
- Facility expansions
- CAPEX project management
- Global regulatory compliance
- CDMO and CMO operations
- Process optimization
- Supply chain leadership
- Cross-functional collaboration
- Process development and tech transfer
- Regulatory inspections and cGMP compliance
Personal Information
Age: 52
Timeline
Senior Vice President, India Operations
Enzene Biosciences Ltd.
07.2020 - Current
VP/Head of Biologic's Manufacturing & Expansions
Reliance Life Sciences
04.2007 - 07.2020
Manager, Development & Manufacturing
Dr. Reddy’s Laboratories (DRL)
08.2001 - 04.2007
Research Scientist
Uni-Sankyo Pvt. Ltd.
08.1999 - 07.2001
Executive Management -
IIM
M.Tech - Biotechnology
Andhra University
B.Pharm -
SCS College of Pharmacy