Ganesh Prasadh Vissvesvaran
Cupertino
Summary
Dynamic leader with extensive experience at Sutro BioPharma, driving CMC strategy and tech transfer for ADC programs. Proven track record in pipeline innovation and regulatory engagement, achieving significant productivity improvements. Skilled in collaborative leadership and Six Sigma methodologies, fostering high-performing global teams to meet ambitious production goals.
Overview
27
27
years of professional experience
Work History
Vice President, Development & MSAT
Sutro BioPharma Inc.
South San Francisco
10.2025 - Current
- Lead the development (Upstream, Purification, Platform, Analytical, Formulation, Drug Linker Process Chemistry), CMC, and outsourced production management (MSAT) teams.
- Set the short- and long-term outsourcing strategies for critical raw materials, intermediates, and final products in the pipeline, based on product lifecycle, and COGS reduction.
- Directed CMC strategy for pipeline ADC programs, ensuring alignment with FDA, EMA guidelines, and regulatory milestones.
- Sponsor the COGs reduction strategy for the Sutro platform production process.
Vice President, MSAT
Sutro Biopharma
South San Francisco
08.2024 - 09.2025
- Lead make, assess, and release activities across upstream, purification, drug linker process, ADC conjugation, and plasmid production.
- Managed internal production of six antibody programs and five critical raw materials.
- Support platform partnering efforts with BioPharma partners.
- Sponsored tech transfer efforts for five antibody/ADC conjugation and critical raw materials across three continents.
- Managed 11 CDMO production sites to meet corporate delivery and cost targets.
Exec. Director, MSAT & Tech Transfer
Sutro BioPharma Inc.
03.2022 - 07.2024
- Sponsor cell line development and strain improvement initiatives, resulting in a 45% increase in productivity.
- CMC leader for a key dual-payload ADC-partnered program.
- Supported dossier preparation and presented at the FDA Type C meeting for platform strategy toward commercialization.
Senior Director, MSAT & Tech Transfer
Sutro BioPharma Inc.
08.2020 - 02.2022
- Integrate data systems for KPI generation using compliant AI tools.
- Strategically improved performance at two CDMO sites to over 90% success rate.
- Complete oversight and build-out of a dedicated production site at CDMO, with a budget of 44 million USD.
Director, Technology Transfer
Sutro BioPharma Inc.
05.2019 - 08.2020
- Manage the new product introduction into the internal production facility.
- Formed the MSAT group with clear service level agreements and objectives.
- Led the OSI Pi historian implementation for all process, utility, and facility skids, integrating islands of automation.
- Author CMC documents for product Drug Master Files, Investigational New Product, and Annual Report for Sutro's products.
- CMC project leader for a partnered program with EMD Serono enabled on-target delivery of IND and FPI.
Senior Manager, Process Technology Development
Genentech Inc.
02.2015 - 04.2019
- Responsible for delivering early-stage Tox material for pipeline programs.
- Delivered a 1 kL 'End to End' Single Use Facility as a single point lead, using best-in-class technology, sensors, and integrated vision for control systems and data collection.
- Core team member of the financial and process modeling team, utilizing BioSolve to enable make vs. buy decisions.
Sr Engineer/Group Leader, Global MSAT
Genentech Inc.
04.2012 - 01.2015
- Tech Transfer Lead for Rituximab to Samsung Biologics, managed 4 engineers, enabled completion of qualification within 12 months of kick-off, and licensure with zero 483s and observations (greenfield facility).
- Author CMC BLA sections for Rituximab, Activase, and Herceptin towards successful filings.
- Overall, the task force lead for the Poloxamer investigation. Managed a global network team of 40 personnel, driving 6 workstreams for Roche sites.
- Technical section contributing author for the poloxamer 'Biological Product Deviation Report' to the FDA, April 2012.
- Managed a cross-company consortium for Poloxamer, and developed standards for screening and release.
- Authored the “Annual Process Monitoring Report” for three commercial products.
- Drove Vendor-Initiated Changes (VICs): (Depth filter/Insulin) with regulatory amendment support for several CHO-based products.
Group Leader/Senior Principal Systems Engineer
Baxter BioScience
01.2011 - 02.2012
- Lead a team of three Engineers in developing processes for implementing and executing process validations for product filings (IOPQ owner).
- Developed a Gemba scorecard, sourced/managed contractors, developed templates for upstream and downstream process/cleaning validations.
Process Engineer, Technical Services
Baxter BioScience
02.2010 - 01.2011
- Tech Transfer lead for ADVATE transfer to Singapore. (Single-Use Bioreactor Implementation)
- Support manufacturing, yield, and process improvement initiatives (depth filtration recovery, implement capacitance biomass probes in the chemostat process, developed a strategy to control pH excursions).
Principal Engineer, Engineering
Baxter BioScience
01.2009 - 01.2010
- Responsible for process equipment, utilities, CAPEX process, and safety at the Hayward site.
- Designed and implemented a new conjugation skid for the Baxter process, installed the 1st Hyclone Single-Use Bioreactor, and GE AKTA Ready chromatography.
- Implemented a sitewide data historian (Wonderware) for all process and utility skids.
Senior Engineer, Process Development
Baxter BioScience
01.2007 - 01.2009
- Process characterization/validation studies using DOE resulting in 4-fold enhancement in titer for Anti-Factor8 antibody.
- Led process characterization efforts in SUB systems (Global R&D award, 2009).
Senior Process Development Associate III
Trubion Pharmaceuticals, Inc
01.2006 - 01.2007
- Mammalian Cell Culture (CHO/Daudi/Rec-1)/Primary Recovery.
- Point person for upstream analytics: ProA Assay execution for titer.
- Transferred the fed-batch process to Laureate Pharma for tox/ Phase 1 (2000L).
Associate Scientist
Acucela Inc
01.2003 - 01.2006
- Principal Investigator: Evaluated the efficacy of a chemical therapeutic in preventing age-related macular degeneration progression (AMD).
- Performed cell culture with mammalian retinal cells, Cos1, RPE19 cell lines; optimized serum free media to enhance culture longevity.
- Purification Process Development/Tech transfer: Developed and optimized A2E purification process using column chromatography and Varion Prep rp-HPLC.
- Automation: Developed extensive testing methods to validate image capture routines and image analysis software using the Olympus Robotic ScanR system.
Process Engineer
Essar Oil Limited
08.1998 - 06.2001
- Supported the design, construction of a 10 Million metric ton refinery with focus on the Naptha Hydrotreater/Reformer units licensed by Instituit Francais du Petrole.
- Led a team of 39 graduate engineering trainees for 22 weeks at Madras Refineries.
Education
M.S - Chemical Engineering
Oregon State University
Corvallis, OR10.2003
B.E. (Hons.) - Chemical Engineering
Birla Institute of Technology and Science
Pilani01.1998
Skills
- CMC Strategy & Execution
- Pipeline & Platform Innovation
- Tech Transfer & Scale up
- Org Design & Talent Development
- IND/BLA Prep & Regulatory Engagement
- Global Team Leadership
- Collaborative/Servant Leadership
- Six Sigma/Green Belt
Accomplishments
CEO Leadership Award for resolving ADC drug linker bioburden issue at CDMO (2025)
Results Award at Sutro BioPharma for key contribution to product milestone (2019).
Recognized as a top contributor (3%) by Roche Process Technical Development (2015,2017).
Winner of Best Development project of the year 2017 for Maximus (Single Use Facility).
Winner of the Roche's PTD Agility Award for the rituximab tech transfer, San Francisco, 2015.
Joint Winner of the Baxter Global R&D Award in the Outstanding Individuals Category for contributions in “Implementation of Disposables Technology”, Vienna, 2009.
Winner of the “DIDOV project of the year” award for the mAbGel redevelopment project, 09/2010.
Received recognition in a letter from US-FDA (Center for Biologics Evaluation and Research) for the seminar “Single Use Disposables in Recombinant Biologics Manufacturing”, 2009.
Results Award at Sutro BioPharma for key contribution to product milestone (2019).
Recognized as a top contributor (3%) by Roche Process Technical Development (2015,2017).
Winner of Best Development project of the year 2017 for Maximus (Single Use Facility).
Winner of the Roche's PTD Agility Award for the rituximab tech transfer, San Francisco, 2015.
Joint Winner of the Baxter Global R&D Award in the Outstanding Individuals Category for contributions in “Implementation of Disposables Technology”, Vienna, 2009.
Winner of the “DIDOV project of the year” award for the mAbGel redevelopment project, 09/2010.
Received recognition in a letter from US-FDA (Center for Biologics Evaluation and Research) for the seminar “Single Use Disposables in Recombinant Biologics Manufacturing”, 2009.
Locations
- Cupertino, CA, 95014
Publications
- Improvement of Bioactive Compound Classification through Integration of Orthogonal Cell-Based Biosensing Methods, Frank W. R. Chaplen, Ganesh Vissvesvaran, Eric C. Henry, Goran N. Jovanovic, Sensors, 2007, 7, 38-51
- Protective Effect of Crocin against Blue Light– and White Light–Mediated Photoreceptor Cell Death in Bovine and Primate Retinal Primary Cell Culture, Aicha Laabich, Ganesh P. Vissvesvaran, Kuo L. Lieu, Kyoko Murata, Tim E. McGinn, Corinne C. Manmoto, John R. Sinclair, Ibrahim Karliga, David W. Leung, Ahmad Fawzi, Ryo Kubota, Invest. Ophthalmol. Vis. Sci., 2006, 47, 3156-3163
- Protective effects of myricetin and related flavonols against A2E and light mediated-cell death in bovine retinal primary cell culture, Aicha Laabich, Corinne C. Manmato, Vladimir Kuksa, David W. Leung, Ganesh P. Vissvesvaran, Ibrahim Karliga, Mahesh Kamat, Ian L. Scott, Ahmad Fawzi, Ryo Kubota
- Dimethylthiourea Protects Retinal Photoreceptors Against Blue Light Stress in Bovine and Primate Primary Cultures, ARVO annual mtg, Fort Lauderdale, 2006
Patents
- Inductive Heat Sterilizing Systems, Devices and Methods, Nick Rummell, Ganesh Vissvesvaran et al, 63/119896, 03/2020
- Methods of preparing a poloxamer for use in cell culture medium, Ganesh Vissvesvaran et al, #WO/2015/148736, 03/25/2015
- Systems and Methods to Improve Protein Yield From Recombinant Manufacturing Processes, Ganesh Vissvesvaran, Sylvain Roy, #WO2013019964 A1, 02/07/2013
Presentations
- Stress-Free ADC production with Cell-Free Technology, World ADC conference, San Diego, 10/18/2023
- Wakey Wakey Sleepyhead”, impact of a polymer film leachable on cell culture performance, ECI Single Use Chapter, Leesburg, VA, 10/2015
- With great shear comes great Poloxamer, IBC conference, San Diego, 03/2014
- Evaluation of Thermo Scientific Hyclone media and feed supplements in a contract manufacturing environment, Bioproduction Optimization Workshop, 10/14/2008
- Redevelopment of processes to meet FDA's new process validation guidelines, Annual Baxter QLP conference, Vienna, 2009
- Myth Busters: Single Use Bioreactors, Wilbio Conference (Baxter Tour), 2008
Timeline
Vice President, Development & MSAT
Sutro BioPharma Inc.
10.2025 - Current
Vice President, MSAT
Sutro Biopharma
08.2024 - 09.2025
Exec. Director, MSAT & Tech Transfer
Sutro BioPharma Inc.
03.2022 - 07.2024
Senior Director, MSAT & Tech Transfer
Sutro BioPharma Inc.
08.2020 - 02.2022
Director, Technology Transfer
Sutro BioPharma Inc.
05.2019 - 08.2020
Senior Manager, Process Technology Development
Genentech Inc.
02.2015 - 04.2019
Sr Engineer/Group Leader, Global MSAT
Genentech Inc.
04.2012 - 01.2015
Group Leader/Senior Principal Systems Engineer
Baxter BioScience
01.2011 - 02.2012
Process Engineer, Technical Services
Baxter BioScience
02.2010 - 01.2011
Principal Engineer, Engineering
Baxter BioScience
01.2009 - 01.2010
Senior Engineer, Process Development
Baxter BioScience
01.2007 - 01.2009
Senior Process Development Associate III
Trubion Pharmaceuticals, Inc
01.2006 - 01.2007
Associate Scientist
Acucela Inc
01.2003 - 01.2006
Process Engineer
Essar Oil Limited
08.1998 - 06.2001
M.S - Chemical Engineering
Oregon State University
B.E. (Hons.) - Chemical Engineering
Birla Institute of Technology and Science