SANMAN SHETTY
Udupi
Summary
Hands-on 10+ years of Downstream experience with outstanding skills in executing biological products in different manufacturing facilities. Strong familiarities with cGMP practices. Experience in process scale up and writing investigation reports. Work diligently meets organizational and personal goals.
Overview
10
10
years of professional experience
Work History
Scientist II Downstream process transfer (Team lead)
VJ Biosciences Pvt Ltd
11.2024 - Current
- Responsible for set-up infrastructure and technical resources to support the MSAT laboratory like URS preparation, equipment qualification
- New product introduction and downstream subject matter expert
- Prepare PDR (Process development report), facility fit assessment and process FMEA/risk assessment prior to initiating a technology transfer
- To lead and execute validation studies such as execution of process performance qualification (PPQ), cleaning validation and continuous monitoring of transferred process
- Preparation of SOPs, MFR (Master formula records) and BMR (Batch manufacturing records) etc
- Effectively maintain good communication and collaborate with cross-functional colleagues for successful execution/completion of projects
- To collaborate and coordinate with upstream Process Engineering, Project Engineering, QA/QC, Program, and Management teams
Deputy Manager Insulin MSAT (Lab Incharge)
Biocon Biologics limited
Bangalore
02.2023 - 11.2024
- Responsible for Lab activities
- Set-up infrastructure and technical resources to support the MSAT laboratory
- Supporting in root cause investigations and scale up /scale down studies for downstream process
- Develop scale-down models of DS process
- Troubleshooting manufacturing downstream operations related to process & equipment performance
- Technology transfer support for consistency/developmental batches at downstream stages
- Process validation support activities for downstream
- Review of TTDs, Process Protocols and Technical Reports related to downstream
- Protocol, MFR and Technical report preparation for downstream
- Support for process related changes, downstream MFR and OFAT experimental data from development teams
- Mentoring junior with respect to process, facility orientation & fast track getting them on board
- Experience in operating Trackwise to initiate and close change control and CAPA
- Provide technical inputs to improve the process development work and to monitor, supervise and access the progress of the work streams
- Experience in e-log book creation and review in Honeywell software
Senior Executive Downstream Manufacturing
Enzene bioscience ltd
Pune
02.2021 - 02.2023
- TTD gap analysis and based on approved TTD, Scale up documentation and BOM, MFR preparation for batch activity
- Responsible for failure investigation and root cause analysis
- Coordinate with cross-functional or supportive department for investigation report preparation
- Preparation and execution of protocol for Process and cleaning validation batches
- Preparation of MFR, BMR and SOP
- Scale up document preparation and batch data presentation for client-based projects
- Perfusion batch execution through continuous chromatography system (Novasep) and Akta PCC and Akta pure
- Independently creating method for chromatography system to execute the perfusion batches
- Production batch activities planning and execution
- Execution of Clinical trails and engineering and PPQ batches
- Carry out both Fed and perfusion batches
- Execution and completion of downstream manufacturing operations (CIP, Chromatography systems, Virus inactivation and neutralization, Nano filtration, UFDF and drug substance preparation)
Senior Executive Biopharmaceutical Operation
Syngene International
Bangalore
07.2019 - 02.2021
- Working in Monoclonal antibody purification by single use technology
- Purification of MAB by means of operating different chromatography column using chromatography skid (unicorn 7.3), in addition to operating UF/DF skids for both ultrafiltration and diafiltration by means of TFF
- Responsibility included carrying out viral inactivation, base neutralization, viral filtration
- Executed downstream processing activities and procedures which included column packing (Asymmetry and HETP determination) and unpacking, UF/DF membrane installation (NWP and integrity checking)
- Execution of equipment qualification (unicorn software 7.3 version OQ execution, column qualification and Gap assessment in equipment qualification)
- Handling deviation
Research Associate in Downstream Process
Unichem laboratories Ltd
Goa
01.2018 - 06.2019
- Familiar with pilot scale and lab scale operations and able to write batch production records
- Collaboration with colleagues in pilot scale operations to devise scale up strategies for downstream process
- Executes purification experiments including automated chromatography (Akta process), clarification, filtration TFF, column packing independently
- Experience in process validation activities
Downstream Manufacturing
Biocon ltd
Bangalore
08.2014 - 01.2018
- Monitor and follow up cGMP systems and housekeeping standards
- Planning and carrying out shift activities
- Experience in validation activities
- Ensuring a safe and clean work environment by following current Good Manufacturing Practices
- Online review of various logbooks, BMR during production activity
- Responsible to get trained on SOP and execution of process operations
- Responsible to coordinate for preventive maintenance and calibration
- Achieving the production target as per schedule by following proper quality and quantities control
- To follow the established procedures and policies of the EHS
- Monitoring and controlling the usage of utilities economically
Education
Master of Science -
St. Aloysius College
Mangalore, Karnataka05.2014
Skills
- Team Player
- Process improvements
- CPV
- Process validation
- Product life cycle management
- Perfusion manufacturing
- Process monitoring
- Equipment qualification
- Purification
- Product handled Mab's
- Interleukin
- Insulin and analogues
- CGMP
- CSV
- Process scale up
- Single Use System
- Operational leadership
- Chromatography systems
- Automated TFF system
- Virus filtration system
Languages
- English, First Language
- Hindi, B2 Upper Intermediate
- Kannada, C2 Proficient
Timeline
Scientist II Downstream process transfer (Team lead)
VJ Biosciences Pvt Ltd
11.2024 - Current
Deputy Manager Insulin MSAT (Lab Incharge)
Biocon Biologics limited
02.2023 - 11.2024
Senior Executive Downstream Manufacturing
Enzene bioscience ltd
02.2021 - 02.2023
Senior Executive Biopharmaceutical Operation
Syngene International
07.2019 - 02.2021
Research Associate in Downstream Process
Unichem laboratories Ltd
01.2018 - 06.2019
Downstream Manufacturing
Biocon ltd
08.2014 - 01.2018
Master of Science -
St. Aloysius College
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