NGUYEN NGUYEN
RICHMOND,USA
Summary
Adaptable, detail-oriented professional with over 6+ years of combined experience in research. Experience in a variety of scientific techniques, including CLIA, ELISA, PCR, PK, ADA immunogenicity testing, and MSD-ECL assay. Proven strengths in performing complex analyses, setting up and operating required scientific instruments to carry out tasks, following procedures, protocols, and SOPs, and maintaining laboratory space. Track record in completing projects in a timely manner, including the majority of projects ahead of schedule with little to no errors. Dedicated and results-oriented Quality Control (QC) Professional with a proven track record in ensuring compliance with company policies, SOPs, cGMP, GLP regulations, and FDA regulations. Known as a fast learner and a great team player who is extremely likeable and works easily with colleagues. Strong analytical, critical thinking, problem solving, and verbal/written communication skills. Seeking a challenging role where expertise in laboratory management, problem resolution, and collaboration can contribute to operational efficiency and product quality.
Overview
7
7
years of professional experience
Work History
Scientist - Automation Specialist
PHARMARON ABS, INC.
12.2023 - Current
- Company Overview: A contract research organization providing drug discovery and development services, post-approval expertise, and compound partnering programs
- Hired by a contract research organization providing drug discovery and development services, post-approval expertise, and compound partnering programs involves designing, implementing, and maintaining automated systems and processes within an organization
- Automated Systems & Process Optimization: Spearheaded the design, implementation, and maintenance of automated laboratory systems, resulting in a 20% increase in operational efficiency and reduced errors across various assays.
Complex Sample Analysis: Conducted high-complexity sample preparation and analysis of pharmaceutical and biopharmaceutical compounds in multiple formulations and biological matrices, adhering to ICH, cGMP, and GLP standards.
Instrumentation Expertise: Led the successful Performance Qualification (PQ) of the Hamilton Vantage Liquid Handling System, releasing it for GxP lab use and enhancing lab throughput by 30%.
Troubleshooting & Problem Solving: Solved complex issues related to assay performance and instrumentation, reducing downtime by 15% and optimizing lab workflows.
Data Integrity & Compliance: Regularly reviewed and compiled analytical results, ensuring data accuracy, technical compliance, and alignment with SOP acceptance criteria, methodologies, and regulatory protocols (cGMP/GLP).
Cross-Department Collaboration: Collaborated with R&D, QC, and production teams to execute unplanned maintenance and troubleshoot issues, ensuring seamless operations and minimizing disruptions.
Vendor Relations & Equipment Maintenance: Managed vendor communications to schedule preventative maintenance and repairs, minimizing equipment downtime and extending instrument lifecycles.
Documentation & Process Improvements: Developed and implemented SOPs, protocols, and reports for lab instrumentation and quality control, contributing to a 10% improvement in lab compliance audits.
Leadership & Training: Trained new hires on automation systems, laboratory processes, and instrument maintenance, fostering a skilled team capable of independently managing high-complexity tasks.
Preventative Maintenance & Calibration: Ensured all laboratory instruments were calibrated and maintained on schedule, preventing potential compliance risks and maintaining high operational efficiency.
Technical Reviews: Conducted self and peer reviews of all laboratory data and processes, ensuring 100% compliance with internal and external audit requirements.
Project Management: Led initiatives to design and develop automation tools and software solutions, significantly improving the laboratory's operational capacity and reducing manual errors.
Strategic Input: Provided technical expertise for automation system selection and implementation, contributing to strategic decisions that enhanced departmental and overall organizational efficiency.
Scientist - Automation Specialist
PPD, part of THERMO FISHER SCIENTIFIC
04.2020 - 12.2023
- Instrumentation Expertise: Operated and troubleshot advanced lab equipment, including Hamilton, Tecan, Gyros, Quanterix, Avidien, Spectramax, MSD plate reader, and Plate Washer, ensuring continuous and accurate performance.
- Maintenance & Compliance: Performed preventative and corrective maintenance, requalification, and validation of triple quadrupole mass spectrometers, improving instrument uptime and ensuring cGMP and GLP compliance.
- Data Integrity: Reviewed and analyzed data for technical accuracy and compliance with SOPs, protocols, and regulatory standards. Conducted peer reviews before QA submission to verify data accuracy.
Workflow Optimization: Served as the liaison between the Automation team and lab staff, streamlining workflows and improving operational efficiency and user experience. - System Validation: Developed system specifications aligned with user needs. Designed validation protocols for integrating new instruments into routine analysis, ensuring smooth transitions.
- SOP Development: Created SOPs, testing protocols, and Performance Qualification (PQ) documents, and produced comprehensive system documentation, including test plans and user manuals.
- High-Throughput Analysis: Processed over 640 samples daily with high reproducibility using TECAN Freedom EVO in both normal and BSL2 environments.
- Sample Testing & Troubleshooting: Conducted initial and confirmation tests for urine and oral fluid specimens in high-volume labs. Troubleshot automated platforms like TECAN, Quanterix, Ella, Jess, and Gyros.
- Assay Development: Led assay development, transfer, and validation, ensuring continuous improvement and adherence to the Validation Plan and regulatory standards.
- Training & Mentorship: Trained lab analysts on testing procedures, reagent prep, and instrument handling, enhancing team skills and maintaining quality standards.
- Lab Leadership: Led the establishment of a new automation lab, managing procurement, installation, and validation of hardware and software, expanding lab capabilities.
- Collaboration: Fostered communication and knowledge sharing across teams, ensuring goal alignment and a collaborative work environment.
- Quality Focus: Worked extended hours during critical phases, delivering high-quality, accurate results under tight deadlines.
Assistant/Associate Scientist
PHARMACEUTICAL PRODUCT DEVELOPMENT (PPD)
11.2017 - 04.2021
- Scientific Experimentation: Designed, executed, and analyzed complex scientific experiments, supporting key research projects and driving innovative solutions for client needs.
- ELISA Method Development: Developed and qualified multiple ELISA methods, effectively troubleshooting issues to meet and exceed client expectations.
- Research & Data Analysis: Conducted scientific research and data analysis to support ongoing projects, ensuring accurate and reproducible results. Presented data comparison and feasibility reports to management for decision-making.
- Mentorship & Training: Trained and mentored new employees, fostering their development and ensuring consistent quality and compliance in lab practices.
- Laboratory Setup & Compliance: Led the establishment of an organized system for a new lab building, ensuring compliance with lab protocols. Oversaw the setup of new instrumentation, facilitating a smooth transition to operational status.
- Inventory Management: Managed and maintained inventory of consumables for entire lab, ensuring operational continuity and preventing delays due to shortages.
- Sample Preparation & Analysis: Performed routine to complex sample preparation and analysis of pharmaceutical and biopharmaceutical compounds across various formulations and biological matrices, adhering to strict protocols.
- Protocol Adherence & Record-Keeping: Conducted experiments and lab procedures according to established protocols, meticulously recording data and maintaining accurate laboratory records to ensure regulatory compliance.
Education
Bachelor of Science - Biochemistry, minor in Chemistry
Virginia Polytechnic Institute And State University
Blacksburg, VA05.2017
Bachelor of Science - Mechanical Engineering
Virginia Polytechnic Institute And State University
Blacksburg, VA05.2017
Associate of Science - Electrical Engineering
Northern Virginia Community College
Annadale, VA05.2013
Skills
Technical Skills
- Laboratory Instrumentation & Innovation: Liquid Handling Systems (Hamilton, Tecan), Gas Chromatography, Liquid Chromatography/Mass Spectrometry (LC-MS), Immunological Assays, Routine Laboratory Operations
- Laboratory Techniques & Assays: Assay Development, Quantitative Skills, Experimental Design, Research & Development of Methods, Laboratory Testing, Data Analysis & Interpretation
- Software & Tools: Matlab, SQL Database, LIMS, MS Office, SharePoint, Tecan Scripting, Software Validation
Laboratory Management & Operations
- Laboratory Management: Staff Hiring, Training & Management, Laboratory Techniques, Safety Processes & Procedures, Scheduling and Planning, Routine Laboratory Operations
- Regulatory Compliance: cGMP, GLP, ICH, FDA Regulations, SOP and Document Development
- Vendor & Client Relations: Vendor Relations, Customer Needs Assessment & Engagement, Vendor Coordination, Technical Support
Leadership & Strategic Planning
- Team Leadership: Leading cross-functional teams, Training and mentoring staff, Strategic Planning
- Project Management: SOP and Document Development, Scheduling, Assay Development, Research and Experiments
Analytical & Problem Solving
- Analytical Problem Solving: Troubleshooting instrumentation and assays, Data analysis, Experimental design
- Quantitative Analysis: Strong quantitative skills in laboratory data handling, Method development, Assay validation
Languages
English
Vietnamese
Timeline
Scientist - Automation Specialist
PHARMARON ABS, INC.
12.2023 - Current
Scientist - Automation Specialist
PPD, part of THERMO FISHER SCIENTIFIC
04.2020 - 12.2023
Assistant/Associate Scientist
PHARMACEUTICAL PRODUCT DEVELOPMENT (PPD)
11.2017 - 04.2021
Bachelor of Science - Biochemistry, minor in Chemistry
Virginia Polytechnic Institute And State University
Bachelor of Science - Mechanical Engineering
Virginia Polytechnic Institute And State University
Associate of Science - Electrical Engineering
Northern Virginia Community College
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