Nilmini Ratnasena
Cumberland
Summary
Accomplished Senior Chemist and Study Director specializing in regulatory compliance and project management. Successfully designed and executed over 100 extractables/leachables studies, maintaining high standards in data analysis and documentation. Demonstrated leadership in cross-functional team settings and mentorship of junior chemists. Proficient in managing regulatory submissions, performing audits, and executing corrective actions.
Overview
10
10
years of professional experience
Work History
Senior Chemist/ Study Director
Jordi Labs, an RQM+ Company
Mansfield
06.2021 - 06.2025
- Designed and executed extractables/leachables studies for over 100 medical device projects.
- Interpreted, analyzed, documented, and reported results per ISO 10993-18 standards and related regulatory guidance.
- Collaborated with sponsors and project managers to optimize protocol design for study objectives.
- Acted as primary client interface for scientific inquiries related to studies.
- Provided scientific and regulatory leadership within cross-functional project teams.
- Ensured that all experimental data, such as GC-MS, LC-MS, HS-MS, ICP-MS, GPC, FTIR, SEM, etc. Including observations of unanticipated responses of the test system, were accurately recorded and verified.
- Authored and reviewed technical documents for test protocols and regulatory submissions. (FDA, MDR, etc.)
- Managed and mentored chemists on lab responsibilities and industry regulations.
- Served as a subject matter expert (SME) for chemical characterization-related queries, as related to laboratory testing, during audits, inspections, and internal reviews.
Research Assistant
University Of South Carolina Columbia
Columbia
08.2015 - 05.2021
- Developed analytical methods and statistical approaches for non-destructive degradation analysis of magnetic audio tapes using infrared spectroscopy and machine learning.
- Generated chemometric models employing linear and quadratic discriminant analyses, logistic regression, support vector machines, decision trees, k-nearest neighbors, and neural networks.
- Collaborated with Library of Congress and University of South Carolina’s Moving Image Research Collection to enhance research outcomes.
Education
Ph.D. - Chemistry
University of South Carolina
Columbia, SC05-2021
Skills
- Regulatory knowledge
- Research skills
- Analytical skills
- Project management
- Adaptability
- Attention to detail
- Team collaboration
- Problem solving
Timeline
Senior Chemist/ Study Director
Jordi Labs, an RQM+ Company
06.2021 - 06.2025
Research Assistant
University Of South Carolina Columbia
08.2015 - 05.2021
Ph.D. - Chemistry
University of South Carolina
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