Carlos Gonzalez
Boyds,MD
Summary
Experience as a Consumer Safety Officer critically evaluating pharmaceutical manufacturer audits for adherence to established technical requirements and legal statutes. Advanced expertise in microbiology, virology, molecular biology, and Current Good Manufacturing Practices (CGMP). Experience developing preclinical models for safety and efficacy testing of biopharmaceuticals. Wide range of experience in communicating highly complex scientific, technical and clinical issues both orally and in writing to multidisciplinary and diverse stakeholders and the general public. Possess skills in identifying problems, recommending solutions, planning, organizing, and advising on the technical aspects of the work. Can plan, organize, and negotiate effectively with management to accept and implement recommendations. Trained in Search and Rescue, Emergency Services, Incident Command System, and the National Incident Management System (NIMS).
Overview
25
25
years of professional experience
4
4
Certifications
Work History
Consumer Safety Officer, GS 13.7, Series 0403
U.S. Food and Drug Administration (FDA)
09.2015 - Current
- Company Overview: Center for Drug Evaluation and Research (CDER), Office of Compliance, Office of Manufacturing Quality (OMQ), Division of Drug Quality I (DDQI), Global Compliance Branch 3
- Website: https://www.fda.gov
- Over nine years of pharmaceutical drug CGMP compliance evaluation and enforcement experience
- Work products include Warning Letters (WL), Regulatory Meetings (RM), Import Alerts, recalls, WL and RM response reviews, COVID-19 response-associated Regulatory Discretions, and consults to various offices
- Team member for the development and implementation of the Compliance Action Tool (CAT)
- Lead case officer for evaluating US and foreign drug establishments’ compliance with the Food, Drug and Cosmetic Act (FDCA) and CGMPs by reviewing inspection findings, drug labeling and other evidence
- Perform risk assessment of inspection violations and determine the appropriate regulatory action to reduce consumer exposure to unsafe and ineffective drugs
- Experience in applying FDA laws and regulations in evaluating Establishment Inspection Reports (EIRs), form FDA-483, firm’s responses and provide advice on drug law regulation and interpretation to ensure compliance with the FDCA and CGMPs
- Ensure that enforcement actions and compliance policies incorporate sound scientific and technical information to protect patients from firms whose quality standards and practices may pose a significant risk to public health
- Review drug manufacturing controls, test methods, validation reports, and determine if drug products conform to monograph requirements and applications
- Monitor and evaluate remedial actions for firms that pose significant risk to public health with the aim of achieving sustainable quality
- Apply knowledge of Microbiology specialties, including manufacturing methodology and assessment as they relate to control of sterilization, contamination, microbiological test methods, stability, and product development
- Coordinate, consult, and collaborate with other FDA offices, divisions, and districts to develop compliance strategies to ensure consistent interpretation of CGMP regulations
- Communicate with other Agency offices and divisions, and regulated industry during meetings, and through written responses including warning letters, decision memos, and inspection assignments
- Conduct briefings for FDA officials and regulated industry representatives
- Inspected drug manufacturing firm for compliance with Current Good Manufacturing Practices
- Integral member of several working groups dedicated to continual process improvements, updates and modifications
- Center for Drug Evaluation and Research (CDER), Office of Compliance, Office of Manufacturing Quality (OMQ), Division of Drug Quality I (DDQI), Global Compliance Group 3
- Website: https://www.fda.gov
- Member of the Environmental Monitoring for Contract Laboratories Training Group for the Compounding Quality Center of Excellence
- Steering Committee of Hispanic/Latino Alliance for CDER Enhancement (HACE)
- Lead for professional development activities
- Speaker for biweekly New Employee Orientations offering an introduction to Diversity, Equity and Inclusion, and the HACE Employee Resource Group to incoming employees
- Active member of the Technical Training Committee
- Lead for training seminars such as: Hands-on High-Pressure Liquid Chromatography (HPLC), two-day course, Back-to-Basics CGMPs: Buildings and Facilities, Chemistry Laboratory controls: Part 1- Out of Specification (OOS) Investigations and Part 2- Method Validation and Stability
- Mentor new staff in the case review process, office processes and procedures
- On-going manuscript drafting and preparation as part of a collaboration with the Division of Applied Regulatory Science (DARS), Office of Translational Science (OTS), in support of FDA’s mission
- Responded to drug shortage and patient risk emergencies as instructed and with utmost efficiency.
- Participated in yearly safety training to identify potential hazards and prevent injuries during several emergency scenarios.
Postdoctoral Fellow
Oak Ridge Institute for Science and Engineering (ORISE)
09.2011 - 09.2015
- Company Overview: U.S
- Food and Drug Administration (FDA), Center for Drug Evaluation and Research, Office of Translational Science, Office of Clinical Pharmacology, Division of Applied Regulatory Science
- Website: https://www.fda.gov
- Over four years of experience in study design and execution evaluating biopharmaceutical immunogenicity, evaluating animal models to address regulatory issues pertaining to immunogenicity of biologicals and providing guidance and training to other scientists
- Co-developed a human-immune system mouse model program at CDER/FDA for pre-clinical bioequivalence, safety and efficacy studies of biopharmaceuticals
- Performed studies assessing anti-CD20 drug product equivalence using human immune system mice to address questions regarding regulatory compliance in the manufacture of originator versus follow-on biological drug products
- Provided consults in the review of New Drug Applications (NDA); specifically, the analysis of the experimental methodology and pre-clinical data interpretation
- Negotiated re-training of animal facility personnel to overcome production challenges, performed follow-up inspections, and evaluated inspection data to ensure compliance with the Institutional Animal Care and Use Committee (IACUC) protocols and the Animal Rule
- Generated and reviewed data to identify areas of microbiological risk in mouse rooms in the FDA animal facility
- Tested excipients in humanized mice to identify potential immunogenicity risks associated with the manufacture of biopharmaceuticals
- U.S
- Food and Drug Administration (FDA), Center for Drug Evaluation and Research, Office of Translational Science, Office of Clinical Pharmacology, Division of Applied Regulatory Science
- Website: https://www.fda.gov
- Several manuscripts and position papers in preparation following research on the legal precedent of the FDCA, and careful interpretation of FDA regulations, policy, and legislation
- Worked in multidisciplinary groups to address challenges in biological product bioequivalence, safety, and efficacy testing platforms
Postdoctoral Fellow
University of North Carolina (UNC)
11.2009 - 05.2011
- Company Overview: School of Medicine, Center for AIDS Research
- Website: https://www.unc.edu
- Conducted and evaluated studies designed to test anti-retroviral treatments as topical microbicides for pre-exposure prophylaxis against Human Immunodeficiency Virus -1 (HIV-1) and HIV-1 clinical isolates in a humanized mouse model
- School of Medicine, Center for AIDS Research
- Website: https://www.unc.edu
Graduate Student
University of North Carolina (UNC)
08.2002 - 05.2009
- Company Overview: School of Medicine, Microbiology and Immunology Department, Lineberger Comprehensive Cancer Center
- Website: https://www.unc.edu
- Conducted and evaluated studies that identified the Kaposi’s Sarcoma-Associated Herpesvirus (KSHV) deubiquitinase (DUB) and established it plays an important role in viral lytic replication
- Characterized signaling pathways activated by the KSHV-DUB
- Identified and characterized a key modulator of the KSHV Replication and Transcription Activator (RTA) protein during lytic replication
- Demonstrated that induction of stress-response signaling pathways is required for efficient KSHV lytic replication
- Established a high-sensitivity, high-throughput, real-time quantitative PCR for whole-genome transcription profiling
- Identified KSHV-encoded microRNAs in latently infected cells
- Communicated study results orally, in posters, and in peer-reviewed publications
- Microbiology Laboratory instructor
- School of Medicine, Microbiology and Immunology Department, Lineberger Comprehensive Cancer Center
- Website: https://www.unc.edu
Post-Baccalaureate Fellow
Intramural Research Training Award (IRTA)
08.2000 - 08.2002
- Company Overview: National Institutes of Health (NIH), National Institute for Diabetes, Digestive and Kidney Diseases
- Website: https://www.nih.gov
- Linked substitutions in hepatitis B virus surface antigen to an ER stress response and the histological features of hepatocellular carcinomas (HCC)
- Collaborated in the correlation of genetic chemokine polymorphisms with disease outcomes in chronic hepatitis C patients, resulting in a publication.
- National Institutes of Health (NIH), National Institute for Diabetes, Digestive and Kidney Diseases
- Website: https://www.nih.gov
Education
Postdoctoral Fellow - Preclinical Animal Models For Testing Biologics.
University of North Carolina
Chapel Hill, NC05.2011
Ph.D. - Microbiology and Immunology
University of North Carolina At Chapel Hill
Chapel Hill, NC05.2009
Intramural Research Training Award (IRTA) Fellow - Hepatitis B And C Virus Pathogenesis.
NIH
Bethesda, MD08.2002
B.S. - Biological Sciences
University of Puerto Rico
Rio Piedras, PR12.1999
Skills
- Regulatory processes and policy experience
- Collaborative Research Efforts
- Cross-Functional Collaboration
- Risk Evaluation
- Risk Assessment
- Pharmaceutical Compliance Expertise
Professional Development
- PDA/FDA Joint Regulatory Conference, Virtual, 09/01/21
- PDA/FDA Joint Regulatory Conference, Washington, DC, 09/01/19
- Tablets & Capsules Hands-On Short Course, University of Maryland School of Pharmacy, Baltimore, MD, 10/01/18
- Boehringer Ingelheim Site Visit, Fremont, CA, 08/01/18
- Micro-Clean training, Bethlehem, PA, 05/01/17
- FDA/PDA Joint Regulatory Conference, Washington, DC, 09/01/16
- ISPE Aseptic Processing Technology Conference, Crystal City, VA, 03/01/16
Awards Recognitions
- Emergency Services Officer of the Year Award, Civil Air Patrol, Maryland Wing, 2021
- FDA Honor Award, For implementing the Agency's Compounding Quality Center of Excellence., 2021
- FDA Honor Award, For coordination and collaboration to ensure the availability of critical drugs to alleviate shortages created during the COVID-19 pandemic., 2021
- FDA Honor Award, For facilitating timely inspections and compliance actions to address safety issues with unapproved porcine thyroid products., 2021
- FDA Honor Award, FDA Group Recognition (Crosscutting), FDA Concept of Operations Management Group., 2020
- Team Excellence Honor Award, As part of the OMQ Technical Training Committee., 2019
- CDER Group and Team Recognition Award for Regulatory Science Excellence, For 'Advancing Biological Drug Products Using Humanized Mice.', 2017
- Lineberger Fellow Award for Excellence in Cancer Research, Lineberger Comprehensive Cancer Center, UNC Chapel Hill, 2009
- Virology Training Grant, Center for AIDS Research, UNC-Chapel Hill, 2007
- Minority Supplement, Minority Biomedical Branch, NCI, NIH, UNC Chapel Hill, 2002 - 2007
- Intramural Research Training Award, NIDDK, NIH, 2000 - 2002
- PRAMP Research Fellowship, 1998
- EPSCoR Fellow, 1997
- Summer internship, Center for Microbial Ecology, Michigan State University, 1997
Leadership Volunteer Positions
- 1st Lieutenant, Civil Air Patrol, Bethesda Chevy-Chase Squadron (MD Wing), 2018 - 2022
- Maryland COVID-19 pandemic response activities, PPE distribution to Montgomery County nursing homes, meal preparation/distribution efforts in Baltimore County, traffic control at COVID-19 drive-through and in-person testing sites, 2019 - Present
- NIDDK, NIH, Intramural Research Training Award (IRTA) Committee Representative, 2000 - 2002
- NIDDK, NIH, Society for the Advancement of Chicanos and Native Americans in Science (SACNAS), 1999 - 2004
- Peer Mentor, University of Puerto Rico, Rio Piedras, PR, in collaboration with Puerto Rico Alliance for Minority Program, 1998 - 1999
- American Society for Microbiologists, UPR Chapter member, University of Puerto Rico, Rio Piedras, PR, 1998 - 2000
Oral Presentations
- Guest Lecturer in 'Researching Climate Change', George Washington University’s Milken Institute School of Public Health, 11/01/22
- Center for Biologics Evaluation Research (CBER) Seminar, Food and Drug Administration, Bethesda, MD, 2011
- Summer of Learning and Research (SOLAR) student seminar, 2010
- Virology Colloquium, Friday Center, Chapel Hill, NC, 2006
- 7th International Workshop on Kaposi Sarcoma-associated Herpesvirus (KSHV) and Related Agents, Hyannis, MA, 2005
- International Meeting on the Molecular Biology of Hepatitis B and associated Viruses, University of Massachusetts, Amherst, MA, 2002
- S.A.C.N.A.S. Annual Conference, Phoenix, AZ, 2001
Personal Information
Available: Immediate
Publications
- Generation and Characterization of Bone Marrow-Liver-Thymus (BLT) Humanized Mice, Carlos M. González, Alan Knapton, Jose Austin, and Kristina E. Howard, Manuscript in prep.
- Evaluation of the Ability of Immune Humanized Mice to Demonstrate CD20-Specific Cytotoxicity Induced by Ofatumumab, Kenrick M. Semple, Carlos M. González, Melissa Zarr, José R. Austin, Vikram Patel, and Kristina E. Howard, Clinical Translational Science, 2019, 12, 3, 283–290
- Bone marrow-liver-thymus (BLT) immune humanized mice as a model to predict cytokine release syndrome, Hangyi Yan, Kenrick M. Semple, Carlos M. González, and Kristina E. Howard, Translational Research, 2019, 210, 43–56
- The Role of eNOS Phosphorylation in Causing Drug-Induced Vascular Injury, Grainne A. Tobin, David Goodwin, Jun Zhang, Sharron Stewart, Alan Knapton, Simona Bancos, Carlos González, Leshuai Zhang, Michael P. Lawton, Bradley E. Enerson and James L. Weaver, Toxicologic Pathology, 2014, 42, 709-724
- KSHV encodes a viral Deubiquitinase, Carlos M. González, and Blossom Damania, Journal of Virology, 2009, 83, 19, 10224-10233
- Identification and Characterization of the Orf49 Protein of Kaposi’s Sarcoma-Associated Herpesvirus, Carlos M. González, Emily L. Wong, Brian S. Bowser, Gregory K. Hong, Shannon Kenney, and Blossom Damania, Journal of Virology, 2006, 80, 6, 3062–3070
- Whole-Genome Transcription Profiling of Rhesus Monkey Rhadinovirus, Dirk P. Dittmer, Carlos M. González, Wolfgang Vahrson, Scott M. DeWire, Rebecca Hines-Boykin, and Blossom Damania, Journal of Virology, 2005, 79, 13, 8637–8650
- Kaposi’s sarcoma-associated herpesvirus expresses an array of viral microRNAs in latently infected cells, Xuezhong Cai, Shihua Lu, Zhihong Zhang, Carlos M. González, Blossom Damania, and Bryan R. Cullen, PNAS, 2005, 102, 15, 5570–5575
- First-generation linkage map of the warningly colored butterfly Heliconius erato, A Tobler, D Kapan, N Flanagan, C González, E Peterson, C Jiggins, J Johntson, D Heckel and W McMillan, Heredity, 2005, 94, 408–417
- Associations of Genetic Polymorphisms in the Chemokine System with Disease Manifestations and Treatment Responses of Chronic Hepatitis C, K. Promrat, D. McDermott, C. González, D. Kleiner, D. Koziol, M. Lessie, M. Merrell, A. Soza, T. Heller, M. Ghany, Y. Park, H. Alter, J. Hoofnagle, P. Murphy, T Liang, Gastroenterology, 2003, 124, 2, 352-360
Certification
Community Emergency Response Team (CERT) Montgomery County, MD 2021
Quality Improvement Associate (CQIA) - American Society for Quality (ASQ) 2019
National Incident Management System - Federal Emergency Management Agency 2018
CPR/First Aid Healthcare Provider - American Heart Association 2018
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
Italian
Limited Working
Timeline
Consumer Safety Officer, GS 13.7, Series 0403
U.S. Food and Drug Administration (FDA)
09.2015 - Current
Postdoctoral Fellow
Oak Ridge Institute for Science and Engineering (ORISE)
09.2011 - 09.2015
Postdoctoral Fellow
University of North Carolina (UNC)
11.2009 - 05.2011
Graduate Student
University of North Carolina (UNC)
08.2002 - 05.2009
Post-Baccalaureate Fellow
Intramural Research Training Award (IRTA)
08.2000 - 08.2002
B.S. - Biological Sciences
University of Puerto Rico
Postdoctoral Fellow - Preclinical Animal Models For Testing Biologics.
University of North Carolina
Ph.D. - Microbiology and Immunology
University of North Carolina At Chapel Hill
Intramural Research Training Award (IRTA) Fellow - Hepatitis B And C Virus Pathogenesis.
NIH
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