Lindelwa Mamba
Rockville
Summary
Meticulous and results-oriented scientist with a proven track record in executing high-quality laboratory procedures under cGMP and stringent regulatory standards. Expertise in generating accurate, reliable analytical data to support clinical testing and method validation, emphasizing quality assurance and continuous improvement. Skilled in troubleshooting complex technical issues, optimizing workflows, and ensuring data integrity in fast-paced, regulated environments. Recognized as a proactive collaborator and results-driven problem-solver, thriving under pressure while committed to advancing scientific innovation and operational excellence.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Associate Scientist III (Virology)
MilliporeSigma CTS
Rockville, MD
01.2022 - Current
- Conducted comprehensive analytical testing for biologic products to uphold data integrity and ensure regulatory compliance with established SOPs, cGMP, and GLP guidelines.
- Documented thorough observations and maintained extensive study records to facilitate quality assurance and accurate reporting.
- Achieved high-quality testing outcomes through precise operation and calibration of laboratory instruments. Enhanced compliance by conducting thorough peer reviews of test records, identifying areas for improvement and ensuring adherence to established standards.
- Utilized software tools to analyze data, manage samples, troubleshoot issues, and optimize laboratory workflows.
- Communicated deviations and interim findings to study management, supporting effective issue resolution and maintaining overall study integrity.
- Collaborated on the development and refinement of SOPs and documentation, ensuring improved clarity and adherence to compliance standards in laboratory operations.
- Achieved flawless tracking of samples and shipments, contributing to operational excellence. Delivered compliance with regulatory requirements through meticulous documentation and order management.
- Coordinated efforts with diverse teams to advance project milestones and ensure successful study outcomes.
Sample Management Technician II
Smithers PDS
Gaithersburg, MD
08.2022 - 05.2023
- Managed numerous sample handling, preparation, and shipment of clinical agents, ensuring compliance with cGMP, FDA requirements, and company quality systems for biologic product testing.
- Entered and tracked data in LIMS to ensure precise sample documentation, inventory control, and regulatory compliance.
- Partnered with managers and client services to resolve discrepancies, address customer inquiries, and maintain accurate databases for seamless operations.
Operations Technician
ThermoFisher Scientific PPD
Rockville, MD
07.2021 - 08.2022
- Prepared and shipped high volume of clinical samples and agents in compliance with internal quality standards and external regulatory requirements; documented cold-chain metrics to ensure integrity of temperature-sensitive materials under cGMP guidelines.
- Lead and designed specimen consolidation projects that increased operational efficiency. Streamlined laboratory workflows by contributing to process improvement initiatives
- Managed data input and monitoring in IMS to ensure timely delivery and compliance with regulatory documentation.
- Partnered with managers and client services to resolve discrepancies, address customer inquiries, and maintain accurate databases for seamless operations.
- Performed data validation, prepared queries, and conducted internal reviews to verify sample accuracy and maintain compliance with FDA and cGMP standards.
Research Intern Protein Characterization Team
Howard University
Washington D.C.
01.2018 - 06.2018
- Leveraged protein databases and bioinformatics tools to compile and analyze molecular data for research projects.
- Gained proficiency in Python and Perl to support machine learning applications in proteomics research
- Collected and analyzed proteomics data to support downstream protein characterization/modeling with machine learning.
- Assisted in protein structure modeling and mutation analysis, providing insights for characterization studies
Education
Bachelor of Science - Biology
Howard University
Washington D.C.07.2022
Master of Science - Microbiology And Cell Science
University of Florida
Gainesville, Florida, FL01-2027
Skills
- Self-driven and motivated
- Lab Techniques
- Aseptic Techniques
- Titrations
- Data Integrity/Validation
- Cell Culture Maintenance
- Mammalian and Insect Cell Culture Assays
- Critical Thinking
- Public speaking
- Effective multitasking
- Team Collaboration
- Project Management
- Quality Event Writing
- CLIA/GCP/GLP/GMP Assay development/validation
- Continuous Improvement Methodologies
- LIMS/ Oracle/QMS/ELN/IMS
- Sample/Inventory Management-Handling
- Microsoft Office Suite (Word, Excel, SharePoint)
Certification
- 6SE Whitebelt, MilliporeSigma - 2022
Languages
French- Intermediate
Zulu- Intermediate
Interests
- Personal Development and Self-Improvement
- Painting Digital Portraits
Timeline
Sample Management Technician II
Smithers PDS
08.2022 - 05.2023
Associate Scientist III (Virology)
MilliporeSigma CTS
01.2022 - Current
Operations Technician
ThermoFisher Scientific PPD
07.2021 - 08.2022
Research Intern Protein Characterization Team
Howard University
01.2018 - 06.2018
Bachelor of Science - Biology
Howard University
Master of Science - Microbiology And Cell Science
University of Florida