Bharama Waghmode
Lund
Summary
Proven, highly experienced executive in end-to-end Capital Projects Management in Drug Substance, Drug Product, Device Assembly and Secondary Packaging projects. Extensive experience in delivering projects with Safety, Quality, Cost, and timely delivery. Managed Capital & Opex projects of varying sizes from USD 2 Mio to USD 120 Mio. Process engineering skills for Process and Equipment troubleshooting and driving Equipment design, Installation, and qualification. Experience to drive Change control, Manufacturing non-conformances and CAPA implementation. Expertise in Bio-process equipment design, SS bioreactors, disposable bioreactors, Autoclaves, CIP systems, Clean utility systems. Aseptic Filling lines, Device Assembly and Automated Packaging lines. Experience to manage the Drug product filling Machines and Aseptic Isolators for PFS, Cartridges and Vials. Design and Qualification of the Secondary Packaging lines for PFS, Vials & Cartridges. Proficient to design the Process sequences for CIP, SIP, bulk sterilization, Aseptic Filtration, and product transfer Steps.
Overview
24
24
years of professional experience
Work History
Line Solution Manager
Tetra Pak Processing
2023.05 - Current
- Responsible for designing and establishing the new food biotech pilot facility
- Vendor selection, techno-commercial, design and qualification for Biomass and Precision fermentation
- Managing end to end solutions of seed and production Bioreactors
- Design, Installation and qualification of Autoclave, Parts washer, Central CIP Systems, and other Manufacturing support equipment
- Successful delivery of generation of best practice line equipment
- Supporting customer enquiries and delivering technical line solutions
Associate Director, Projects & Process Engineering
Biocon Biologics Limited
2018.04 - 2023.05
- Concept, Basic and detail engineering for Facility and Process equipment like SS Bioreactors, Single use Bioreactors, Media and Harvest tanks, Continuous centrifuge, Autoclave, washers, Clean utility generation systems etc
- Responsibility for Capital budget preparation, Control and feasibility assessment for new projects
- Vendor selection, techno-commercial, Design and Qualification of Pre-filled syringe filling line for r-proteins and Mabs
- Successful delivery of Secondary packaging line for Cartridge Assembling & Packaging facility at Biocon Sdn Bhd Malaysia
- On time delivery for Single use manufacturing facility comprises the 2000L
- 3 single use Bioreactors with perfusion devices and other supporting Process equipment
- Completed the Basic engineering for Drug substance (50KL capacity) & Drug Product (40 million capacity line) for Insulin analogous at Biocon Sdn
- Bhd Malaysia
- Managing the Device assembly and packaging for Auto-Injectors devices (Disposable pen devices and Pre-filled Syringes)
- Techno-commercial assessment and design support for platform sites for design support and value negotiation
- Malaysia and India
Senior Process/Projects Engineer
Novartis Sterile Manufacturing
2012.07 - 2018.03
- Establishment of new equipment set up for technology transfer projects (Involves the design, Installation and qualification of portable reactors, transfer piping, Filling Machine and Process automation etc)
- Overall Project management, design, construction, and qualification of Secondary packaging line (sterile ophthalmic products) for Japanese market
- Experience in manufacturing of Process and Equipment troubleshooting (Process Reactors, Filling line, Packaging, and transfer lines)
- Responsible for Non-conformances and CAPA implementation for process and equipment deviations
- Experience in process recipe execution for CIP, SIP, Bulk sterilization, and transfer steps
- Managed the Process Improvement and Compliance projects in compounding and filling line
- Supported regulatory team for Market complaint investigations and deviations
- Singapore
Deputy Manager, Projects and Process Engineering
Biocon Limited
2010.01 - 2012.01
- Responsible for FAT, SAT, commissioning and qualification for Media, Buffer preparation Tanks, 2000L Bioreactor, Seed Bioreactors, Continuous Centrifuge, Autoclave, Central CIP station, Mobile CIP station, Inactivation Tank and Clean Utilities generation/distribution systems
- Preparation for URS, enquiries, techno-commercial comparison, and design review for assigned projects
- Process recipe establishment for CIP, SIP and Media transfer sequences
- Supported for warehouse expansion projects
- Co-ordination with Project consultant, Equipment suppliers and on-site piping contractors for Installation and site acceptance testing for Process equipment & Clean utilities
- Bangalore India (Biologics Division)
Senior Executive, Production
Syngene International Limited-CDMO
2007.01 - 2010.01
- Commissioned and Start-up of 300L Cell culture and 225L Microbial suite pilot plant
- Experience in Facility start up and executed the engineering runs
- Process engineering support for recipe field testing and troubleshooting to establish CIP, SIP, and sequences
- Supported for various Key process Equipment FATs, Installation for Bioreactors, Continuous centrifuges, Autoclave, Water generation systems etc
- Generation of facility start up documents, SOPs, MBRs and Equipment check list
- Biocon Company, India
Production Executive
Wockhardt Biotech Limited
2004.01 - 2007.01
- Company Overview: Aurangabad India (r-Insulin Manufacturing)
- Shift leader for upstream area for fermentation activities and managed the day-to-day activities
- Co-ordination with Engineering and automation for troubleshooting and timely issue resolution
- Monitoring & controlling in-process parameters for seed and production fermenters
- Experience in planning turnaround time for CIP, SIP and organizing production activities
- Experience in preparation of facility start-up documents, standard operating procedures, and batch manufacturing records
- Managed the Manufacturing deviations and CAPA implementation
- Aurangabad India (r-Insulin Manufacturing)
Technical Officer
Kingwin Chemicals Limited
2001.01 - 2003.01
- Managed the technical services for water and descaling chemicals for various industries
- Experience in managing the regional industries for demonstration and testing at client sites
- Supply chain network to supply the water treatment chemicals
- Jaipur India
Education
Bachelor in Chemical Engineering -
Shivaji University
Executive General Business management programme - Bangalore
Indian Institute of management
Skills
- Analytical
- Deliberative
- Self-Assurance
- Restorative
- Business Analysis
Websites
Professionalachievements - Strategicprojects
- Design and technical transfer (USA and EU sites to Asia) to increase the products portfolio.
- Design, Installation, SAT, IQ & OQ of SS Bioreactors set up for Capacity of 9000L
- 6 scale for Biosimilars (Honorable mention winner FOYA ISPE)
- Successfully delivered the Single Use Manufacturing facility (2000L Scale) for next wave of molecules.
- Successful establishment of 300L cell culture and 225L Microbial suite pilot plant for development and clinical products.
- Design, Installation and Qualification of recombinant Insulin manufacturing facility (30KL Fermenters scale).
- Procurement, design, FAT, Installation and Qualification of Pre-filled syringe Filling line (for Recombinant proteins and Monoclonal antibodies).
- Successful design, Installation, and qualification of Automated Syringe & Pen Assembling & Pen Packaging Projects.
- Concept & Basic engineering for 50KL Fermenters, supporting equipment and Cartridge Filling line for Insulin analogous products.
Confirmation
I hereby confirm that the above information is true.
Timeline
Line Solution Manager
Tetra Pak Processing
2023.05 - Current
Associate Director, Projects & Process Engineering
Biocon Biologics Limited
2018.04 - 2023.05
Senior Process/Projects Engineer
Novartis Sterile Manufacturing
2012.07 - 2018.03
Deputy Manager, Projects and Process Engineering
Biocon Limited
2010.01 - 2012.01
Senior Executive, Production
Syngene International Limited-CDMO
2007.01 - 2010.01
Production Executive
Wockhardt Biotech Limited
2004.01 - 2007.01
Technical Officer
Kingwin Chemicals Limited
2001.01 - 2003.01
Bachelor in Chemical Engineering -
Shivaji University
Executive General Business management programme - Bangalore
Indian Institute of management
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