Dynamic scientist with a proven track record at PPD, part of Thermo Fisher Scientific, excelling in assay development and regulatory compliance. Adept at collaborating with cross-functional teams, I leverage strong attention to detail and effective communication to drive results in laboratory research and data analysis. Committed to maintaining high standards in quality and accuracy.
Overview
10
10
years of professional experience
Work History
Scientist
PPD, part of Thermo Fisher Scientific
Richmond
05.2023 - 03.2025
Responsible for the review and compilation of results, and data comparison against SOP acceptance criteria, methodology, protocol, and product specifications.
Performed self and peer review of the data for accuracy and compliance with reporting requirements, prior to submission to QA and issuance to customers.
Reviewed, interpreted, and analyzed data for technical, quality, and compliance with protocols, methods, SOPs, client criteria, and Good Laboratory Practices (GLP).
Performed hSBA assay on the BRAVO robot using knowledge of BSL-2 lab practices and aseptic technique to support regulated and non-regulated testing.
Monitored laboratory equipment performance, performed repairs, calibrations, and preventative maintenance as necessary.
Trained on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines.
Completed all laboratory documentation in clear and accurate language, and according to SOP and GLPs.
Worked with multiple functional teams (Pipette Investigations, Hamilton Logbook Review, Non-Clinical Data Verification) to meet business needs.
Interpreted complex scientific information into understandable language for non-scientific audiences.
Senior Regulatory Affairs Specialist at PPD, part of Thermo Fisher ScientificSenior Regulatory Affairs Specialist at PPD, part of Thermo Fisher Scientific