Aishwarya SY
Galway, Ireland
Summary
Highly motivated postgraduate with a year of research experience and expertise in clinical sample analysis and lentiviral vector-based gene therapy. Spearheaded several research projects with effective communication, research writing and management skills. Proficient in regulatory compliance standards such as ICH GCP E6 (R2), GDPR, GLP, cGMP ISO 9000 and 13485. Demonstrated excellence in project management methodologies like LEAN Six Sigma and CAPA. Strong background in laboratory management with a focus on critical thinking, team building, attention to detail, communication and problem solving. Career goal includes contributing to innovative research projects within a dynamic organization.
Overview
4
4
years of professional experience
5
5
years of post-secondary education
Work History
Sample Coordinator
University of Galway
Galway, Ireland
05.2024 - Current
- Collecting, receiving, and logging clinical trial samples according to study protocols and standard operating procedures (SOPs).
- Processed over 200 blood components, stool, urine, and saliva samples.
- Ensured proper sample cryopreservation and maintained comprehensive repository for sample storage.
- Provided input on Site-Specific Workflows (SSWs) for all biospecimen collection and testing needs, ensured consistency and compliance with regulatory standards.
- Performed ELISA and Flowcytometry analysis from clinical serum and saliva samples for identification of specific biomarkers.
- Managed laboratory inventory to ensure smooth operation and readiness for analyses.
- Supported sample distribution for research purposes, ensuring adherence to ethical guidelines.
- Reviewed laboratory proposals in collaboration with vendor management, providing budget input for trial forecasts and reviewing invoices.
Biochemical and Microbiology Lab Demonstrator
University of Galway
Galway, Ireland
01.2023 - 03.2023
- Prepared laboratory samples and established experimental setups for undergraduate students, ensuring conducive learning environment.
- Provided hands-on assistance in operation of various scientific instruments, including microscopes, PCR machines, colorimeters, spectrophotometers, and gel electrophoresis equipment.
- Maintained sterile laboratory environment and guided over 75 students in cell culture techniques to promote good laboratory practices.
- Documented and maintained accurate records of laboratory activities, experiments, and student progress to support academic integrity and research continuity.
- Provided constructive feedback on student's performance after every session leading to their continuous improvement.
Quality Control (QC) Analyst
Stellis Biopharma
Coimbatore, India
05.2021 - 06.2022
- Conducted raw material analysis and environmental monitoring in compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) regulations to ensure product quality and safety.
- Performed testing of current Good Manufacturing Practice (cGMP) products using advanced analytical techniques, including spectrophotometry, high-performance liquid chromatography (HPLC), and reverse transcription polymerase chain reaction (RT-PCR).
- Engaged in process validation activities and reviewed standard operating procedures (SOPs) to enhance operational efficiency and maintain regulatory compliance.
- Streamlined workflow with efficient analytical strategies.
Education
Master of Science - MSc Regenerative Medicine NFQ Level 9
University of Galway
Ireland 09.2022 - 11.2023
Bachelor of Technology - Biotechnology
SIET, Anna University
Coimbatore, Tamil Nadu 08.2017 - 05.2021
Skills
- Technical Skills: RT-PCR, ELISA, Viral vector preparation, Stem cell and mammalian culture, Tissues culture, Immunostaining, Processing of blood, saliva, stool and urine samples, Flowcytometry, Western blotting, MTT assay, BCA assay, Lectin staining, Fluorescence microscopy, Spectrophotometer, Basic HPLC, Technical writing
- Software Skills:
Microsoft Office, ImageJ, Fusion 360, LIMS, Biobank Inventory - Management Regulatory Compliance: ICH GCP E6 (R2), GDPR, GLP, cGMP ISO 9000 and 13485
- Project Management: LEAN Six Sigma, Project Management, CAPA, Root Cause Analysis, Laboratory Management
- Soft Skills: Critical thinking, Team building, Attention to detail, Communication and Problem solving
Certifications
- LEAN Six Sigma Green Belt
- ICH GCP E2
- GMP from USP
- Certified Associate in Project Management from University of Galway
- Participated in Indo-UK Virtual Conference, “Current Innovations and the Future of Therapeutic Developments” conducted by Vellore Institute of Technology
Publications
- An anxious relationship between Autism Spectrum Disorder and Gut Microbiota: A tangled chemistry? https://doi.org/10.1016/j.jocn.2022.03.003
- A new insight into the diverse facets of micro-RNA-31 in oral squamous cell carcinoma https://doi.org/10.1186/s43042-022-00361-2
Timeline
Sample Coordinator
University of Galway
05.2024 - Current
Biochemical and Microbiology Lab Demonstrator
University of Galway
01.2023 - 03.2023
Master of Science - MSc Regenerative Medicine NFQ Level 9
University of Galway
09.2022 - 11.2023
Quality Control (QC) Analyst
Stellis Biopharma
05.2021 - 06.2022
Bachelor of Technology - Biotechnology
SIET, Anna University
08.2017 - 05.2021
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