Cynthia Gonzalez
Encino,CA
Summary
Skilled in facilitating daily clinical trial activities, bring extensive expertise in molecular biology and a proven track record in efficiently managing complex processes. Recognized for successful leadership in high-paced laboratory operations, I am adept at optimizing workflows and ensuring adherence to strict processing protocols to meet regulatory standards. Utilizing a proactive approach minimizes project timeline delays through effective document management, and plays a pivotal role in audit preparation activities. Additionally, excel in coordinating with various departments to streamline sample processing and fostering collaborative relationships with Principal Investigators, sponsors, and stakeholders. Eager to contribute skills to the success of cutting-edge research initiatives.
Overview
8
8
years of professional experience
Work History
Staff Research Associate II - Manager
University California Los Angeles (UCLA Health- Dr. Antoni Ribas)
05.2021 - Current
- Calibrating laboratory operations and ensuring team-research productivity in high-volume laboratory
- Oversaw hiring, onboarding, and evaluation of staff, contributing to a high-performing team environment.
- Directly involved in immunotherapy research-grade protocols participating in good-practices studies, manufacturing of cellular products, and translational-medicine trials
- Laboratory operations officer and director of clinical-research specimens processing and tissue Biobank management
- Conducting patient-derived in-vivo xenografts expansion on immunocompromised mouse models and primary cellular product derivation from patient biopsies
- Participating in high-impact manuscript elaboration, scientific writing, and novel clinical and pre-clinical-oriented data generation
- Coordinate US and International shipping of cellular products purchased from the lab
- Work with vendor-product pricing arrangements for quotes and stratification of laboratory supplies, consumables, and other materials
- Receive clinical and research specimens obtained from clinical trials, ensuring proper downstream processing, access, and storage or analysis
- Process, isolate, bank, and validate AB-serum collected from IRB-approved protocols for the culture of TILs (tumor-infiltrating lymphocytes)
- Perform screens and analysis of endotoxin(s) in cell culture supernatants
- Actively participate in experiments related to processing Tumor Infiltrating Lymphocytes (TILs) and PBMC activation for novel cellular therapies proof-of-concept experiments
- Participate in the isolation, validation, and qualification of nucleic acids from specimens collected from primary lesions for sequencing and computational analysis
- Collaborating with colleagues during planning meetings regarding project timelines, and project-related issues focusing on capabilities within, but not limited to, Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management
- Minimize delays in project timelines through proactive management of document revisions, updates, and follow-ups with relevant parties
- Play an integral role in audit preparation activities, including gathering requested documentation, organizing materials, and facilitating communication with auditors to ensure a smooth process
- Work with several Principal Investigator and sponsors to facilitate daily trial activities and comply with research protocols
- Serve as liaison between the research team, study sponsors, regulatory authorities, and study participants
- Keep all stakeholders informed about progress of the study and address any concerns or questions
- Managed budgets and allocated resources effectively to ensure sufficient staffing levels and availability of necessary equipment and supplies.
- Ensured compliance with regulatory guidelines and accreditation standards through consistent monitoring and implementation of corrective actions when needed.
Clinical Laboratory Technician Trainer
LabCorp- National Genetics Institute
11.2020 - 05.2021
- Perform routine and complex technical procedures in accordance with Standard Operating Procedures (SOPs)
- Monitor, operate, and troubleshoot instrumentation to ensure proper functionality and accuracy of results
- Make technical decisions regarding testing and problem-solving, ensuring high-quality standards
- Enhanced laboratory efficiency by streamlining sample processing and data entry procedures.
- Reduced turnaround time for critical tests by optimizing laboratory workflows and processes.
- Maintained a safe work environment by adhering to strict safety protocols and guidelines in the lab.
- Trained new laboratory technicians, ensuring consistent adherence to best practices and standard operating procedures.
- Consistently met high-performance standards, maintaining precise documentation of test results and findings.
- Assisted in the evaluation of new equipment and technology, helping to maintain cutting-edge capabilities within the laboratory setting.
- Handled sensitive patient information with confidentiality, following HIPAA guidelines at all times.
- Trained and mentored 14 new personnel hired to fulfill various roles.
Household Manager/ Executive Assistant
Harris Family
01.2018 - 05.2021
- Communicate effectively with household workers, ensuring a collaborative and well-organized living environment
- Manage a full household, overseeing day-to-day activities and responsibilities
- Ensure all three children adhere to their schedules and arrive on time for activities
- Schedule payroll for household staff, ensuring accurate and timely compensation
- Coordinate weekly work schedules for household workers to optimize efficiency
- Communicate with doctors and teachers to stay informed about the well-being and progress of the family members
- Successfully coordinated events with 50+ attendees, demonstrating organizational and planning skills.
- Fostered positive relationships with service providers, ensuring timely delivery of services and effective communication.
- Cultivated a safe environment by implementing security measures and protocols specific to the needs of the family.
Researcher- Laboratory Manager
California State University Los Angeles
05.2016 - 05.2019
- Proficient in SDS-PAGE, Western blotting, and gel electrophoresis for protein analysis
- Execute Polymerase Chain Reaction (PCR) for DNA amplification and analysis
- Conduct fungal transformation experiments, demonstrating expertise in molecular techniques
- Cultivate mammalian cells using aseptic techniques in a laboratory setting
- Perform Gram staining to characterize bacterial species
- Conduct biofilm assays to study microbial adherence
- Expertise in cell counting methods for various applications
- Train and manage new undergraduate researchers and researchers joining the laboratory
- Guide laboratory techniques, safety protocols, and experimental design.
- Trained staff, scheduled work hours, and assigned projects for the 11-person work group.
Education
Bachelor of Science - Microbiology
California State University Los Angeles (CSULA)
Los Angeles, CA05.2018
Bachelor of Science - Biology
California State University Los Angeles (CSULA)
Los Angeles, CA05.2018
Skills
- Laboratory safety protocols
- Staff Training and Development
- Project management experience
- Equipment Maintenance and Calibration
- Clinical Laboratory Management
- Regulatory Compliance Knowledge
- Budget Planning and Monitoring
- Automated Laboratory Testing
- Quality Control
- Blood and Tissue Sample Collection
- HIPAA Compliance
- Good Laboratory Practices (GLP)
- Analytical Problem Solving
- Critical thinking abilities
Abilities
- Molecular Biology, gDNA Extraction, Advanced, 8 years, Present, RNA Isolation, Advanced, 8 years, Present, DNA Gel Extraction, Advanced, 8 years, Present, PCR, Advanced, 8 years, Present, RT-PCR, Advanced, 8 years, Present, Electrophoresis Agarose, Advanced, 8 years, Present, qPCR SBYR Green, Advanced, 8 years, Present, Multiplex PCR Assay for HCV, HIV-1, HIV-2 and HBV, Intermediate, 8 years, 21-May, HCV RT-PCR Assay, Intermediate, 8 years, 21-May, HCV v2 RT-PCR Assay, Intermediate, 8 years, 21-May, HIV-1 RT PCR Assay, Intermediate, 8 years, 21-May, HIV-1 v2 RT PCR Assay, Intermediate, 8 years, 21-May, HBV PCR Assay, Intermediate, 8 years, 21-May
- Molecular Cloning, E. Coli Transformation, Advanced, 6 years, Present, Mini - Midi - Maxi (Endo-free) plasmid DNA preparation, Advanced, 5 years, Present
- Mammalian Tissue Culture, Human melanoma adherent primary cell Culture Derivation & Expansion, Advanced, 3 years, Present, In vivo xenograft implantation of tumor biopsies NSG-immunocompromised mouse model, Intermediate, 3 years, Present, Derivation and propagation of tumor infiltrating lymphocytes, Advanced, 3 years, Present
- Laboratory Medicine, Laboratory Equipment Calibration, Advanced, 8 years, Present, Quality Control, Advanced, 8 years, Present, Laboratory Testing & Reporting, Advanced, 8 years, Present, Test Result Validity & Verification, Advanced, 8 years, Present
- Statistics, Biostatistics, Advanced, 8 years, Present
- Administrative Laboratory Skills, Laboratory Management & Administration, Advanced, 8 years, Present, Personnel, graduate, and undergraduate student advising/training, Advanced, 8 years, Present, Facility Administration, Advanced, 8 years, Present, Laboratory Equipment Management, Research Specimens Cataloging and Standard Operating Procedures Archival utilizing eLab, Intermediate, 3 years, Present, Biobank Clinical Specimen Collection Accessing and Tissue Management on BTM, Advance, 3 years, Present, Digital Tissue Collection Specimens Procurement, Advanced, 3 years, Present, cGMP Material Storage and Handling Receipt, QA-Release, Aliquoting, Inventory, Advanced, 8 years, Present, Document Control SOPs/Forms/Protocol Writing, Validation, and Revision, Advanced, 8 years, Present, Aseptic Process Validation SOPs and Forms Preparation, Performance and Verification, Advanced, 8 years, Present
Training
- University of California, Los Angeles, Flow Cytometry Methods for the Analysis and Isolation of Pluripotent Stem Cells and their Derivatives, 1 hour
- University of California, Los Angeles, Multicolor Flow Cytometry, 1 hour
- University of California, Los Angeles, 7th Annual Stem Cell Symposium, 6 hours
- Division of Laboratory Animal Medicine, Working with Animals at UCLA, Training Module, 30 hours
- Health Environment & Safety Department, Bio-safety Module, 12 hours
- Health Environment & Safety Department, Saf-T-Pak - Shipping of Division 6.2 Dangerous Goods, 9 hours
- California Nanosystems Institute, EL 406 BioTek, 3 hours
- California Nanosystems Institute, Mantis (Formulatrix), 3 hours
- California Nanosystems Institute, Multidrop384 (Thermo LabSystems): Manifold liquid dispensing, 3 hours
- California Nanosystems Institute, ImageXpress(Molecular Devices): A high throughput epifluorescence microscope, 5 hours
- California Nanosystems Institute, Envision(Perkin Elmer): High speed plate reader for 96 or 384 and 1536 well plates, 5 hours
Timeline
Staff Research Associate II - Manager
University California Los Angeles (UCLA Health- Dr. Antoni Ribas)
05.2021 - Current
Clinical Laboratory Technician Trainer
LabCorp- National Genetics Institute
11.2020 - 05.2021
Household Manager/ Executive Assistant
Harris Family
01.2018 - 05.2021
Researcher- Laboratory Manager
California State University Los Angeles
05.2016 - 05.2019
Bachelor of Science - Microbiology
California State University Los Angeles (CSULA)
Bachelor of Science - Biology
California State University Los Angeles (CSULA)
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