Niliksha Gunewardene Email and Phone Number
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I’m dedicated life sciences researcher with a deep passion for making healthcare accessible to everyone. I thrive on challenges and constantly seek to push my limits. I believe in the power of teamwork and strive to create a strong leadership culture wherever I work.At CSL, my role as a Senior Scientist in Bioanalytical Sciences hinges on pioneering cell-based assays for critical product characterization and regulatory compliance. This involves intricate experiment design, execution, and data analysis, all tailored to uphold stringent pharmaceutical standards.Our team has successfully facilitated OGTR and TGA audits through meticulous documentation and lab operation management. My commitment to research excellence is further underscored by my concurrent position as an Honorary Research Fellow at the University of Melbourne and Bionics Institute, where I continue to contribute to the fields of gene therapy and neuroscience.
Csl
View- Website:
- csl.com.au
- Employees:
- 14897
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Senior Scientist, Csl Innovation- Bioanalytical Sciences, BioassaysCsl Aug 2023 - PresentMelbourne, Victoria, Australia• Lead development of cell-based assays including experiment design planning, implementation, analysis, troubleshooting and data presentation to stakeholders• Perform cell-based assays including batch release and stability sample testing for product characterization • Author and review procedures and SOPs for equipment and assays, including preparing study reports and regulatory response statements• Directly assist with OGTR audits and support TGA audits in relation to document updates and lab maintenance• Maintain effective lab operations in guidance with pharmaceutical drug regulations• Participate in discussions regarding cell-based assay strategy and tech-transfer• Conduct development discussions and development plans with direct report
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Independent ConsultantFreelance Sep 2024 - Present
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Honorary Research FellowBionics Institute Aug 2024 - PresentMelbourne, Victoria, Australia -
Senior Research Fellow- Project Lead Hearing Gene TherapyBionics Institute Oct 2018 - Aug 2023Melbourne, Australia• Led teams of researchers to complete independent research into developing gene therapy approaches to treat sensory and neurodegenerative disorders (provisional patent submitted July 2023).• Led commercial gene therapy contract projects from inception to completion, ensuring objectives and timelines met to support business needs.• Conducted research in developing nanoparticles approaches for targeted drug/gene delivery into the inner ear. Currently in preparation for first in-human clinical trial.• Developed assays to characterise nanoparticle-released drug pharmacokinetics (cell-based bioactivity tests and radiolabel assays).• Supervised 2 Research Assistants, 7 Masters Students, 1 Capstone student and 2 Honours students Research funded by NHMRC Ideas Grant (CIA Gunewardene, 2024-2027) and Development Grant (CIF Gunewardene, 2021-2023)
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Honorary Research FellowUniversity Of Melbourne Oct 2018 - Jul 2023 -
Postdoctoral Research FellowMassachusetts Eye And Ear Oct 2014 - Aug 2018Massachusetts Eye And Ear Infirmary- Boston• Developed unique research into use of inner ear stem cell-derived organoids to establish large-scale drug screening platform.• Tested drug mechanisms using cell-based and molecular assays (FACS, flow cytometry, western blots, qRT-PCR, ELISA, ChIP, RNA-sequencing)• Worked to improve collective knowledge of epigenetic mechanisms underlying hair cell differentiation and regeneration.• Inventor on US patent focused on above research (WO2020112883A1).• Supervised team of 3 Research Assistants and assisted co-supervising 1 PhD student at Harvard University, Boston (2014-2018)
Niliksha Gunewardene Skills
Niliksha Gunewardene Education Details
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Postdoctoral Fellowship- Auditory Neuroscience -
Auditory Neuroscience, Stem Cell Biology
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Medical Science -
Medical Science
Frequently Asked Questions about Niliksha Gunewardene
What company does Niliksha Gunewardene work for?
Niliksha Gunewardene works for Csl
What is Niliksha Gunewardene's role at the current company?
Niliksha Gunewardene's current role is Senior Scientist, CSL.
What is Niliksha Gunewardene's email address?
Niliksha Gunewardene's email address is ni****@****ail.com
What schools did Niliksha Gunewardene attend?
Niliksha Gunewardene attended Harvard University, University Of Melbourne, The University Of Auckland, University Of Auckland.
What skills is Niliksha Gunewardene known for?
Niliksha Gunewardene has skills like Science, Research, Neuroscience, Cell Culture, Biochemistry, Stem Cells, Molecular Biology, Tissue Culture, Scientific Writing, Confocal Microscopy, Microscopy, Cell Biology.
Who are Niliksha Gunewardene's colleagues?
Niliksha Gunewardene's colleagues are Jose Luis Perez Arredondo, Amber Willis, Dennis Johnson, Tom Walls, Robert Van Horne, Marine Coubard, Abigail Morris.
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