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🔬 Greetings! With over five years of industry experience and a combined 18 years of expertise in academic and industry research, I bring a unique blend of technical depth, quality assurance, and operational efficiency to biotechnology and product development. My career is defined by a commitment to elevating product standards through rigorous scientific methods, strategic process optimization, and a robust understanding of regulatory compliance.🌟 Expertise:• Technical Mastery & Innovation: Skilled in developing and optimizing in vitro diagnostic (IVD) products, mRNA vaccines, and cell therapies. I lead verification and validation studies for IVDs and oversee upstream (cell culture, media preparation) and downstream (purification, product formulation) processes, achieving performance enhancements across projects.• Quality Assurance Leadership: Experienced in building quality control systems aligned with GxP, CLSI, USP, ICH, and FDA/CE/ISO standards, ensuring quality integration throughout the production lifecycle to uphold product integrity.• Operational Strategy: Proven success in optimizing workflows to enhance efficiency and productivity. I align operational strategies with business objectives, ensuring technical advancements drive measurable results.• Regulatory & Compliance Acumen: Skilled in navigating regulatory landscapes to support market entry for new innovations, with a focus on risk management and meticulous regulatory attention.🎯 Career Goal: I seek opportunities requiring a blend of technical expertise, quality focus, and operational strategy to advance biotech and pharma innovations. I am drawn to roles that challenge me to apply my skills in driving both technical and operational excellence.💼 Collaboration and Growth: I thrive in environments committed to continuous improvement and collaborative success. Connecting with like-minded professionals in biotech and innovation is a key focus.📧 Let's Connect! If you're looking for a results-driven professional who bridges technical development, quality assurance, and operational efficiency to enhance product quality and compliance, please reach out. I am excited to explore how I can contribute to your team and support your business goals.
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Qa Gmp Operation LeadArcellx Aug 2023 - May 2024Redwood City, California, Us• Documentation & Compliance Leadership: Spearhead the creation and meticulous review of GxP documentation across multiple projects, ensuring robust compliance. Oversee critical documents, including Quality Assurance Agreements, technical summaries, deviation reports, and SOPs.• Validation Leadership: Lead essential validation initiatives for facilities, equipment, processes, and computerized systems. Responsibilities include conducting data integrity assessments, developing User Requirement Specifications (URS), Validation Master Plans (VMP), and executing IOPQ phases to ensure GxP readiness.• cGMP Facility Development: Contribute to the planning and setup of a new cGMP-compliant cell therapy manufacturing facility, aligning operations with FDA regulations for seamless operational readiness.• Risk & Quality Management: Drive comprehensive risk assessments and refine CAPA processes, strengthening quality management systems and enhancing partner collaboration.• Data Management Excellence: Develop and maintain detailed databases for laboratory notebooks, CRO data, and clinical batch records, ensuring data integrity, accuracy, and accessibility across all records. -
Senior ScientistRnaimmune Apr 2022 - Jul 2023• Process Optimization: Led optimization of in-house in vitro transcription processes, achieving a 40% increase in yield and reducing material costs and process time by 50%, significantly enhancing efficiency.• Method Development: Developed new assay procedures in strict alignment with USP, ICH, and FDA guidelines, improving reliability, reproducibility, and regulatory compliance.• Project Management: Skilled in managing multiple high-impact projects, consistently meeting critical milestones and ensuring on-time delivery of key project objectives.• Bioprocessing Oversight: Oversaw upstream and downstream bioprocessing activities, upholding rigorous quality standards and operational efficiency in production.• Risk Management: Developed and implemented risk mitigation strategies that ensure adherence to quality standards and project timelines, fostering a proactive quality culture.• Cross-Functional Collaboration: Engaged in collaborative meetings with internal teams, management, vendors, and CDMOs to drive cohesive project execution and maintain alignment with project goals. -
Scientist IiUsamriid , Us Army Medical Research Institute Of Infectious Diseases Sep 2021 - Apr 2022Frederick, Maryland, Us• Transcriptomic Project Leadership: Led resource management, design, and execution of advanced transcriptomic projects using Next Generation Sequencing (NGS), including studies on immune response mechanisms and antimicrobial strategies.• Data Management Excellence: Built and maintained comprehensive databases for specimen tracking and analysis, improving data accessibility and streamlining research workflows.• Team Development & Training: Supervised and mentored junior staff, providing training in technical procedures and safety protocols, ensuring high standards in lab practices and data integrity.• Scientific Communication: Authored and co-authored technical reports and manuscripts for publication, contributing valuable insights and advancements to the scientific community. -
Assistant Laboratory Director (Remote)Endeavor Dna, Inc. Feb 2018 - Feb 2022Here’s a LinkedIn-optimized version based on your resume that highlights each responsibility effectively:• Audit & Compliance Support: Assisted in preparing for AABB and ISO audits, actively contributing to maintaining high operational standards and ensuring regulatory compliance across laboratory practices.• Quality Assurance Oversight: Directed quality verification of laboratory analysis reports to align with AABB standards, consistently upholding high-quality outputs and regulatory adherence.• Professional Consultation & Testimony: Provided expert consultation and testified in legal cases, effectively communicating laboratory findings and methodologies in court.• Scientific Advisory Role: Delivered scientific guidance on complex cases, supporting the enhancement of laboratory techniques and improving diagnostic accuracy. -
ScientistQiagen Aug 2019 - Aug 2021Venlo, Limburg, Nl• Assay Development & Optimization: Developed and optimized LFIA-based immunodiagnostic assays for SARS-CoV-2 antigen and antibody detection, using ELISA for immune response assessment. Ensured adherence to CLSI, FDA, and CE guidelines, upholding high diagnostic accuracy standards.• Project Leadership: Served as technical lead for the SARS-CoV-2 antigen project, overseeing all phases of planning, coordination, and execution while managing a team of three to meet critical deadlines.• Resource Management: Directed resource planning and coordination across multiple studies, ensuring efficient project execution and timely completion of objectives.• Regulatory Compliance: Played a key role in FDA and CE registrations, contributing to compliance and securing market approval for new diagnostic tests.• Training & Protocol Development: Developed and delivered clinical training protocols for academic institutions and CROs, supporting clinical and investigational study success.• Documentation Management: Authored, reviewed, and maintained essential documentation, including SOPs, work instructions, and validation protocols, ensuring alignment with regulatory standards.• Cross-Functional Collaboration: Strengthened project integration by facilitating collaboration across QA, QC, Clinical Affairs, Marketing, and Statistical teams.• Data Management: Established and maintained databases for specimen tracking and data analysis, enhancing data accessibility and research efficiency.• IVD Device Development: Led development and optimization of IVD devices using QIAreach and QuantiFERON platforms for tuberculosis, COVID-19, and Lyme disease, advancing diagnostic capabilities.
Naihsuan C. Guy, Ph.D. Skills
Naihsuan C. Guy, Ph.D. Education Details
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Vaccine & Infectious Disease Organization – International Vaccine Centre (Vido-Intervac)Vaccine And Infectious Diseases -
The University Of Texas At El PasoPathobiology
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University Of Arizona College Of Medicine – TucsonMicrobiology & Immunology
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New Mexico State UniversityMicrobiology
Frequently Asked Questions about Naihsuan C. Guy, Ph.D.
What is Naihsuan C. Guy, Ph.D.'s role at the current company?
Naihsuan C. Guy, Ph.D.'s current role is Biotech Professional Specializing in IVD, Vaccine Development, and Cell Therapy | Expert in Quality Assurance, Process Optimization & Compliance | Driving Technical Innovation with Quality and Operational Excellence.
What is Naihsuan C. Guy, Ph.D.'s email address?
Naihsuan C. Guy, Ph.D.'s email address is ch****@****ail.com
What is Naihsuan C. Guy, Ph.D.'s direct phone number?
Naihsuan C. Guy, Ph.D.'s direct phone number is +130625*****
What schools did Naihsuan C. Guy, Ph.D. attend?
Naihsuan C. Guy, Ph.D. attended Vaccine & Infectious Disease Organization – International Vaccine Centre (Vido-Intervac), The University Of Texas At El Paso, University Of Arizona College Of Medicine – Tucson, New Mexico State University.
What skills is Naihsuan C. Guy, Ph.D. known for?
Naihsuan C. Guy, Ph.D. has skills like Science, Problem Solving, Project Management, Molecular Biology, Teamwork, Cell Biology, Research, Life Sciences, Cell Culture, Biochemistry, Communication, Microscopy.
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