Houston, Texas, United States
Key Accomplishments Expertise in Regulatory Compliance: Successfully supervised clinical laboratories, ensuring compliance with CLIA, CAP, and API standards, and navigating complex regulatory landscapes with precision. Leadership in High-Complexity Labs: Skillfully managed drugs of abuse in DOT occupational toxicology and prescribed drug compliance within therapeutic drug monitoring programs in high-complexity laboratory settings. Prolific Scientific Contribution: Authored 50 peer-reviewed research articles, showcasing a consistent record of scientific accomplishment and innovation. Leadership and Mentoring: Demonstrated exceptional leadership, collaboration, and mentoring capabilities, fostering a culture of excellence and growth within research teams. Subject Matter Expertise: Recognized as a Subject Matter Expert (SME) in Mass Spectrometry, Proteomics, and Metabolomics, leading translational research projects with impactful results. Collaborative Research Excellence: Successfully collaborated with Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs), driving innovative research and development initiatives. Drug Development Knowledge: Possess thorough knowledge of the drug development lifecycle, from initial discovery to late-phase trials, ensuring seamless transitions and regulatory compliance. Product Development Proficiency: Expertise in drug product development processes, characterization, CMC content, and regulatory guidelines, with a proven track record in vaccine development research. Biomarker Discovery: Pioneered biomarker discovery in metabolomics, genomics, and proteomics, uncovering novel therapeutic targets and advancing precision medicine. Validation and Method Transfer: Experienced in the validation and transfer of methods used for drug compound characterization, ensuring consistency and reproducibility. Innovative Research Scientist: Motivated and goal-oriented, with a strong track record of directing and managing proteomics and metabolomics core facilities. Problem-Solving Expertise: Renowned for excellent troubleshooting and problem-solving skills, delivering high-quality data and technical support. Effective Communication: Exceptional writing, verbal, and interpersonal skills, facilitating clear and impactful communication within research teams and with stakeholders. Creativity and Adaptability: A creative and fast learner, always open to scientific challenges and committed to advancing the frontiers of clinical chemistry and biotechnology.
• Leading a team of laboratory technicians and data analysts. • Developing and performing validations on LC-MS instruments, operations, and troubleshooting. • Leading the laboratory in screening and confirmatory evaluations. • Certifying and reporting results according to SOPs and regulatory requirements • Pain management and therapeutic drug monitoring • Proficiency testing and reporting • Managing the compliance with CLIA, CAP, API laboratory standards, and accreditation by adhering to regulatory guidelines
Analyzing LC-MS/MS and GC-MS data Certifying and reporting results according to SOPs and regulatory requirements Consulting with Laboratory Managers and Directors concerning results Applying QC practices and procedures to the review, interpretation and reporting of results and monitor chain-of-custody documentation Validation of new methods
Development of highly sensitive methods for the identification and quantitation of Opioids in the presence of Adulterants by GC-MS Spectrometry Establishing Sufficiency Thresholds for Assessing the Quality of Mass Spectral Data
Designing, coordinating and executing proteomics research projects related to cancer biomarker discovery and implementation