Andrew Bae

• Provide ongoing technical training and support for team members and collaborators in assay development and laboratory management, ensuring efficient implementation and operation of new diagnostic technologies
• Perform various assays to identifying antibody correlates of protection in support of influenza vaccine research and development under GCLP guidelines.

• Performed transfection/infection of insect cell for the production of influenza HA antigens in GCLP laboratory
• Performed Quality Control of proteins produced in the PPF; perform SDS-PAGE, Western blotting, endotoxin testing and size exclusion chromatography via AKTA instrumentation
• Performed production and quality control of plasmids and bacmids used for expression of proteins in mammalian and insect cells; transform bacterial cells for plasmid/ bacmid production.

• Ensured data accuracy and regulatory compliance by supporting quality assurance processes and consulting with stakeholders
• Managed clinical virology and diagnostics analysis for company clinical trials
• Designed and implemented molecular diagnostic methods, including NGS, PCR, and DNA/RNA isolation techniques and associated instrumentations
• Developed qPCR and RT-qPCR assays for norovirus, AdV, CMV, and Ectromelia
• Created sequencing assays for mutation identification and genotype classification
• Provided technical expertise to external labs for project development and troubleshooting
• Performed lab operations, including specimen handling, inventory management, equipment calibration, and safety compliance
• Authored and reviewed technical documents such as SOPs, Virology Plans, and Clinical Virology Reports
• Collaborated with internal and external scientists on research and implementation of new techniques.
• Supported development of in-process, raw material and release testing.
• Conducted genotypic and viral load investigations, standardized testing and instrument qualifications.
• Maintained laboratory environment, performed investigations and standardized testing.

• Ensured data accuracy and regulatory compliance by supporting quality assurance processes and consulting with stakeholders
• Managed clinical virology and diagnostics analysis for company clinical trials
• Designed and implemented molecular diagnostic methods, including NGS, PCR, and DNA/RNA isolation techniques and associated instrumentations
• Developed qPCR and RT-qPCR assays for norovirus, AdV, CMV, and Ectromelia
• Created sequencing assays for mutation identification and genotype classification
• Provided technical expertise to external labs for project development and troubleshooting
• Performed lab operations, including specimen handling, inventory management, equipment calibration, and safety compliance
• Authored and reviewed technical documents such as SOPs, Virology Plans, and Clinical Virology Reports
• Collaborated with internal and external scientists on research and implementation of new techniques.

• Led clinical diagnostics lab, optimizing workflow to meet HIV and HCV milestones
• Ensured compliance with CLIA and GCLP through accurate documentation, SOPs, and technical reports
• Collaborate with Bioinformatics to design a sequence database for HIV and HCV data analysis and reporting
• Conducted amino acid mutation analysis, reducing susceptibility to anti-HCV drug candidates
• Molecular diagnostic method development (NGS, PCR, qPCR) to support clinical trials, ensuring regulatory compliance
• Collaborated with external partners (Virco) on oligonucleotide design and method optimization
• Worked with cross-functional teams to troubleshoot diagnostic issues, ensuring customer satisfaction and regulatory adherence
• Awarded 2009 Carolina STAR by NC-DHHS for lab inspection preparedness
• Negotiated procurement to upgrade lab systems, increasing throughput and reducing costs
• Played a key role in securing FDA approval for Emtriva by leading resistance analyses during clinical trials
• Provided training, technical support, and troubleshooting to staff and interns on lab techniques
• Developed allele-specific qPCR and single-genome sequencing methods to detect low-frequency viral mutations
• HCV genotyping protocols to detect resistance mutations in NS3, NS4A, and NS5B genes in genotypes 1a and 1b.

• Led clinical diagnostics lab, optimizing workflow to meet HIV and HCV milestones
• Ensured compliance with CLIA and GCLP through accurate documentation, SOPs, and technical reports
• Collaborate with Bioinformatics to design a sequence database for HIV and HCV data analysis and reporting
• Conducted amino acid mutation analysis, reducing susceptibility to anti-HCV drug candidates
• Molecular diagnostic method development (NGS, PCR, qPCR) to support clinical trials, ensuring regulatory compliance
• Collaborated with external partners (Virco) on oligonucleotide design and method optimization
• Worked with cross-functional teams to troubleshoot diagnostic issues, ensuring customer satisfaction and regulatory adherence
• Awarded the 2009 Carolina STAR by NC-DHHS for lab inspection preparedness
• Played a key role in securing FDA approval for Emtriva by leading resistance analyses during clinical trials
• Provided training, technical support, and troubleshooting to staff and interns on lab techniques
• Developed allele-specific qPCR and single-genome sequencing methods to detect low-frequency viral mutations
• HCV genotyping protocols to detect resistance mutations in NS3, NS4A, and NS5B genes in genotypes 1a and 1b.
• Designed and executed studies to support usability of solutions, analyze data and provide actionable recommendations to project team.
• Achieved project objectives by troubleshooting experiments and testing practical and creative solutions.
• Directed, guided and delegated tasks to teams and developed project schedules, resource requirements and timelines to maintain productivity on goals and objectives.
• Contributed to scientific discussions with peers and management personnel.
• Generated and upload assay data and communicated results and reports to multi-disciplinary project teams to influence progression in discovery and development.
• Developed solutions by researching advanced technologies, methods for modeling and predicting performance outcomes and innovative approaches for personalized and adaptive user support.
• Communicated project status to [Type] management verbally and through technical documentation and presentations.
• Initiated, planned and executed research projects under supervision of senior scientist.
• Gathered and organized information for research purposes.
• Guided development of adaptive systems framework that integrated data from multiple sources to augment training and operational performance.
• Leveraged highly effective communication and active listening skills to work effectively scientists of diverse backgrounds and accomplish common research goals.
• Created and implemented procedures to obtain required information and support research goals.
• Performed in-depth interviews with research subjects and compiled data and analyses into reports for review by group leader.
• Completed over [Number] tests on [Type] research participants, recorded findings in [Software] and reported them to supervisors.
• Assisted [Number] scientists with in-depth data research in both lab and office environments.
• Implemented [Type] programs to increase public education of [Area of expertise] and share newly developed research findings.
• Cut research supply costs by $[Amount] through keeping precise and diligent records of supplies used and needed in [Software].
• Took active role in departmental meetings, engaging with all parties and transcribing detailed notes of plans, decisions and options discussed.
• Collected and recorded data at various field sites for later assessment and data analysis.
• Organized [Type] research from start to finish by designing effective questionnaires and data entry procedures.
• Created over [Number] research summaries and presented them to supervisors to advocate further research and funding.
• Disseminated research findings to personnel as white papers, presentations and spreadsheets.
• Used [Software] to enter data into project database and provided regular updates.
• Digitized and organized [Type] data using [Software] to streamline research procedures.
• Reviewed and verified [Type] data before entering into database to enhance research quality and accuracy.
• Utilized statistical packages to analyze data and create visualizations.

• Developed, optimized and validated the ABI3100 system for HIV-I genotypic analysis
• Led HIV ENVA proficiency testing program, evaluating new genomic technologies including Affymetrix, Visible Genetics, ALF, Line Probe Assay, ABI377, and ABI3100
• Specimen handling of biological samples, including bacteria/viruses requiring BSL-2 containment.

ELISA diagnostic assays Amplicor HIV-1 Monitor on infected human blood and plasma specimen to generate HIV data for use in diagnosis and treatment of disease

• Maintain laboratory operations per GCLP and CLIA guidelines while complying with safety standards
• Document quality control & results, troubleshoot instrument malfunctions and monitoring result deviations and implement quality assurances.