Loshanan Sivapalan
Sydney,NSW
Summary
Results-oriented microbiologist with expertise in veterinary pharmaceuticals, combining scientific knowledge with strong business acumen. Skilled in vaccine manufacturing, aseptic techniques, and GMP compliance. Known for translating complex technical data into value-driven solutions while staying attuned to industry trends. Demonstrated excellence in cell culturing, analytical thinking, and cross-functional teamwork. Proven track record in improving vaccine production processes, consistently upholding quality and safety standards.
Overview
9
9
years of professional experience
1
1
Certification
Work History
VTM production coordinator
Treidlia Biovet Pty Ltd
Sydney, NSW
09.2023 - Current
- Timely Ordering: Coordinate the timely ordering of Virus Transport Medium (VTM) buffer with the media team.
- Filling Session Coordination: Organize filling sessions based on production requirements, and distribute the roster to VTM lab operators.
- Equipment Setup: Set up peristaltic pumps for dispensing VTM into sterile tubes.
- Filling Supervision: Supervise VTM filling sessions in clean rooms, ensuring compliance with protocols and quality standards.
- Sterility Testing: Collect sterility samples for each VTM batch and prepare documentation for external testing.
- Batch Documentation: Ensure all VTM batch records and Certificates of Analysis (CoAs) are prepared and signed by authorized personnel.
- Labelling and Packaging: Oversee the labeling and packaging of VTM tubes to ensure accuracy and compliance.
- Dispatch Coordination: Liaise with the warehouse team and customer service associates to ensure the timely dispatch of VTM tubes to NSW health.
Microbiology Associate Level 2
Treidlia Biovet Pty Ltd
Sydney, NSW
05.2021 - Current
- Performing validation studies for processes, QC testing, and laboratory environments to show that the manufacturing is GMP compliant.
- All R&D-related vaccine manufacturing studies involving new viral vaccines, including kinetics, inactivation, and scale-up studies.
- Lead lab sessions to maintain and subculture cell stocks, virus infection, and virus harvesting.
- Monitor in-process quality testing of viral vaccines, including virus titration, virus inactivation testing, sterility testing of antigen, and cell culture media batches, etc.
- Calculation of virus titer for antigen batches and vaccine batches by the TCID50 assay.
- Testing FBS batches to meet cell and virus production standards.
- Formulation of vaccine batches in consultation with the department manager.
- Maintenance and cryopreservation of cells and virus seed stock.
- Plan the preparation of ELISA and immunofluorescence buffers, and supervise and guide operators in performing the assays as required
- Assessing personal and environmental monitoring records of lab sessions.
- Ensure that all records are appropriately maintained according to the GMP standards.
- Provide training to new staff and guidance on new procedures, ensuring team members understand how to maintain both individual and group training records.
- Troubleshoot and resolve any equipment issues within the virology department, contacting external suppliers when necessary.
- Collaborate with technical experts in relevant fields to implement improvements to equipment setups, enhancing the efficiency and effectiveness of vaccine production processes.
- Draft procedural and equipment SOPs, and prepare batch forms for production activities in the virology laboratory.
- Maintain laboratory consumable inventory, antigen production records, and media usage logs, while ensuring timely requests for necessary documents.
- Liaise with the quality team to maintain calibration and validation records of equipment and labs.
- Assist in APVMA, OGTR, and DAWE audits.
- Tracking all vaccine batch records and related documents per GMP guidelines.
- Facilitate continuous improvements by ensuring long-term corrective actions are incorporated into the process to prevent recurrence.
Microbiology Associate Level 1
Treidlia Biovet Pty Ltd
Sydney, NSW
05.2019 - 04.2021
- Participate in the manufacturing and R&D activities of the various viral vaccine projects, according to set standards.
- Maintenance and subculture of cell stocks in flasks, roller bottles, and multi-well plates.
- Perform various steps of antigen production: virus infection, freeze-thaw of roller bottles, harvesting, centrifugation, etc.
- Prepare ELISA and immunofluorescence buffers, and perform assays as required on viruses that do not exhibit visible cytopathic effects.
- Preparation of cell culture media batches by sterile filtration using different peristaltic pumps.
- Perform in-process quality testing of viral vaccines, including virus titration, virus inactivation testing, sterility testing of antigen and media batches, etc.
- Perform environmental and personal monitoring during lab sessions, and liaise with the quality team to manage the availability of plates, and keep records.
- Weekly/Monthly stock take of laboratory consumables and chemicals.
- Emulsification and filling of vaccine batches in a cleanroom facility.
- Quality control testing of emulsified products: droplet test, microscopic examination, and gravity test.
- Keeping records on assigned forms, as per GMP compliance.
- Assist in APVMA, OGTR, and DAWE audits.
- Facilitate continuous improvements by ensuring long-term corrective actions are incorporated into the process to prevent recurrence.
Microbiology Laboratory Assistant
Treidlia Biovet Pty Ltd
Sydney, NSW
11.2018 - 05.2019
- Preparation of materials: washing, packing, and labeling of centrifuge bottles, tubing, and media tanks for autoclaving.
- Daily monitoring of recommended temperatures of virology facilities: labs, cool rooms, refrigerators, freezers, and incubators.
- Replenish consumables and chemicals in the virology lab.
- Routine cleaning, organization, and fumigation/disinfection of the virology lab.
- Planned cleaning of equipment: roller racks, refrigerators, freezers, CO2 incubator, centrifuges, etc.
- Logistic support for transferring materials: media tanks, adjuvant drums, roller bottle boxes, filled vaccine tubs, etc.
- Daily disposal of quarantine, clinical, and general lab waste into assigned bins.
- Assist in the maintenance and subculture of cell stocks in flasks, roller bottles, and multi-well plates.
- Assist in various steps of antigen preparation: virus infection, freeze-thaw of roller bottles, harvesting, centrifugation, etc.
- Assist in the preparation of cell culture media batches by sterile filtration.
- Assist in the emulsification and filling of vaccine batches in a cleanroom facility.
- Keeping records on assigned forms, as per GMP compliance.
Internship Student
Treidlia Biovet Pty Ltd
Sydney, NSW
09.2018 - 11.2018
- Rejuvenation of bacterial cultures and cell lines from various seed cultures.
- Propagation of starter and intermediate bacterial cultures using rejuvenated strains.
- Sampling of cultures for quality control (QC) testing, and examining and studying the bacterial growth.
- Enumeration of bacterial cultures.
- Various microbiological streaking methods for rejuvenation, purity checks, and bacterial growth.
- Maintaining aseptic conditions in laboratories and clean rooms by following Good Laboratory Practices.
- Maintaining and monitoring all consumables and equipment used in the laboratory to ensure compliance with sterility standards.
Internship
Dipped products PLC
Colombo, Western
06.2016 - 12.2016
- Worked on a project to improve the leaching process proteins and calcium in the final product to reduce the allergic effects on the users.
Internship
Astron Ltd
Colombo, Western
11.2015 - 12.2015
- Performed quality control tests on raw materials and final products.
- Performed routine water testing.
- Performed reagents and solutions required to perform the testing for raw materials and final products.
- Performed microbiological testing on certain final products.
Education
Master of Science - Biotechnology And Business
Macquarie University
Sydney, NSW11-2018
Bachelor of Science - Microbiology, Biotechnology And Biochemistry
University of Mysore
Mysore, India04-2016
Skills
- Vaccine manufacturing (bacterial and viral)
- Cell culturing
- Virus harvesting
- Aseptic techniques
- Equipment handling, technical troubleshooting, and problem solving
- Validation studies for equipment and procedures
- GMP and GLP requirements, and compliance
- Enzyme-Linked Immunosorbent Assay (ELISA)
- Immunofluorescence assays
- APVMA audit requirements
- Knowledge of ISO 9001 and ISO 17025
- Good attention to detail
- Analytical thinking and good decision-making skills
- Good time management
- Good team player
- Good interpersonal and communication skills
- Good work ethics
- Knowledge of ISO 45001 relating to health and safety in the workplace
Languages
English
Native/ Bilingual
Tamil
Native/ Bilingual
Sinhala
Full Professional
Hindi
Limited
Kannada
Limited
Malayalam
Limited
Accomplishments
- Appointed School Prefect(High-school)
- Awarded Colours for the accomplishment in the 1st XI soccer team(2010,2011-High school)
- Art Club President - Organized the Annual Art Exhibition in my High School- 2010.
- Represented the SMCA NSW Cricket Team against MYCA VIC cricket Team in 2023.
Affiliations
I play competitive cricket on weekends, enjoy badminton, and cycle 100 km per week. Additionally, I have a passion for skiing and make a trip with a group of friends every year.
Certification
- Approved Arrangements for Accredited Person (Classes 1 to 8)
- Biosecurity Awareness
- Cyber Security Awareness Course
Timeline
VTM production coordinator
Treidlia Biovet Pty Ltd
09.2023 - Current
Microbiology Associate Level 2
Treidlia Biovet Pty Ltd
05.2021 - Current
Microbiology Associate Level 1
Treidlia Biovet Pty Ltd
05.2019 - 04.2021
Microbiology Laboratory Assistant
Treidlia Biovet Pty Ltd
11.2018 - 05.2019
Internship Student
Treidlia Biovet Pty Ltd
09.2018 - 11.2018
Internship
Dipped products PLC
06.2016 - 12.2016
Internship
Astron Ltd
11.2015 - 12.2015
Master of Science - Biotechnology And Business
Macquarie University
Bachelor of Science - Microbiology, Biotechnology And Biochemistry
University of Mysore
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