ZULAY FERNANDEZ
BC US LLC
Naples,FL
9
years of professional experience
Results-driven Laboratory Technician with years of experience in biotechnology, pharmaceutical manufacturing, process development, clinical diagnostics, and microbiology laboratories. Strong expertise in downstream processing, chromatographic purification, analytical testing, and GMP-regulated operations. Proven ability to support research, development, manufacturing, and quality initiatives while maintaining compliance with regulatory requirements and industry standards. Extensive hands-on experience with High-Performance Liquid Chromatography (HPLC), Reverse-Phase HPLC (RP-HPLC), peptide purification, recombinant protein purification, sample preparation, method execution, and laboratory troubleshooting. Knowledge of peptide synthesis processes, purification workflows, process optimization, and analytical characterization techniques. Familiar with Mass Spectrometry (MS) principles and applications through technical training and laboratory coursework. Skilled in preparing solutions, buffers, reagents, and microbiological culture media while following Standard Operating Procedures (SOPs), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and data integrity requirements. Background in microbiology, analytical chemistry, organic chemistry, inorganic chemistry, and liquid-phase separation techniques. Adept at collecting, analyzing, and interpreting experimental data, maintaining detailed laboratory records, and generating technical documentation to support manufacturing and development activities. Recognized for contributing to process improvements, quality assurance initiatives, and cross-functional projects that enhanced laboratory efficiency, product quality, and regulatory compliance. Experienced in training and mentoring laboratory personnel on laboratory techniques, safety procedures, quality standards, and best practices. Highly organized, detail-oriented, and committed to scientific excellence. Seeking to leverage expertise in purification technologies, chromatography, and pharmaceutical manufacturing to contribute to innovative biotechnology and pharmaceutical organizations focused on advancing therapeutic products and process development.
Work History
I+D, Process Development and Production
5 Years 7 Months- Conducted experiments to purify and analyze chemical compounds, ensuring adherence to safety and quality standards.
- Utilized advanced laboratory equipment, including Hipersep & Shimadzu HPLC, RP-HPLC, Chromatography & Liquid-Phase Separations, Mass Spectrometry (MS), Thin-Layer Chromatography (TLC)
- Implemented process improvements including Peptide Synthesis, Lyophilization of Pharmaceutical Products, Microbiology & Clinical Analysis
- Preparation of Solutions, Reagents, and Laboratory Materials
- Conducted electrophoresis, PCR, ELISA, Microcomasie and Western Blot techniques to analyze biological samples and validate experimental results.
- Trained new team members on laboratory safety protocols and purification techniques to promote a high standard of practice.
- Developed and implemented best practices for waste management and disposal in the laboratory setting.
- Provided technical support for scaling up purification processes from lab to production levels.
- Assisted in the validation of purification processes, ensuring they met both internal and external quality benchmarks.
- Performed stability testing of pharmaceutical products, contributing to regulatory submissions and product development.
- Contributed to the development of standard operating procedures (SOPs) for analytical testing processes.
- Demonstrated respect, friendliness, and willingness to help wherever needed.
- Assisted with day-to-day operations, working efficiently and productively with all team members.
Clinical and Microbiology Laboratory
1 Year 5 Months- Self-motivated, with a strong sense of personal responsibility.
- Worked effectively in fast-paced environments.
- Executed precise microbiological tests and analyses, ensuring compliance with laboratory protocols and safety regulations.(Stool Culture, Hematology, Bacteriology, and Parasitology, Microscopic Analysis of Blood, Urine, Fecal and Biological Samples, Clinical Chemistry: Coagulopathies, RBC Indices, Reagent Strip Analysis)
- Collaborated with cross-functional teams to develop and implement new testing methodologies, improving overall laboratory efficiency. (proficiency test twice in a year)
- Developed standard operating procedures (SOPs) for laboratory processes, contributing to consistent and reliable testing practices.
- Maintained inventory of laboratory supplies, reducing stock shortages and ensuring continuous availability of essential materials.
- Participated in internal audits and inspections, reinforcing adherence to quality assurance standards.
- Performed routine maintenance on culture media and reagents, ensuring all materials were up to standard for testing.
- Clinical Chemistry: Coagulopathies, RBC Indices, Reagent Strip Analysis.
- Blood borne Pathogen Handling and Zoonosis Safety• IACUC Compliance, Animal Welfare, and 3 Rs Principles.
- CDC Quarantine Sample Procedures and compliance.
Education
- Chemical Engineering
GPA: 3.55pts
- Research Project:
1.Development of a new purification process for the NS3 protein of VPPC, with the study of the influence of biomass washing with 2m urea and 1% triton x100 detergent and 0.005 mol/l imidazole, in cami chromatography as a step for impurity removal.
2.Evaluation of sanitation and disinfection of immunomodulatory peptide 814 (Jusvinza) production areas.
- Thesis: Evaluation of the purification process of the Hepatitis B virus nucleocapside antigen.
- Extracurricular Activities: Synthesis of immunomodulatory peptide 814 (Jusvinza)
High School Diploma
GPA: 92.08%
Skills
Hipersep
Shimadzu HPLC
Liquid-Phase Separations
Protein & Peptide Purification
Analytical Chemistry
Organic Chemistry
Mass Spectrometry Principles
Thin-Layer Chromatography (TLC)
Synthetic Peptide Synthesis
Microbiology & Clinical Analysis
Preparation of Solutions
Reagents
and Laboratory Materials
Electrophoresis
PCR
ELISA
Western Blot
Microcomasie
Lyophilization
Sample Handling and Storage
Biological Safety Cabinets and Laminar Flow Hoods
Autoclaves and Ultrasonic Equipment
Microbiological Media Preparation and Culture Handling
Laboratory Equipment Calibration and Maintenance
Microscopic Analysis of Blood
Urine
Fecal and Biological Samples
Clinical Chemistry: Coagulopathies
RBC Indices
Reagent Strip Analysis
Antibody Detection and Identification
Stool Culture
Hematology
Bacteriology
and Parasitology
Cell Washing
Disruption
and Protein Solubilization
Viral and Vaccine Analysis (e.g.
Covid-19
Hepatitis B
Dengue)
Campaign Execution
Batch Naming
and Production Documentation
Shipping of Biological Samples
CDC Quarantine Sample Procedures and compliance
Data Entry
Chromatographic Data Acquisition
Good Documentation Practices (GDP)
Good Laboratory Practices (GLP)
Good Manufacturing Practices (GMP)
Good Microbiology Practices
Quality Assurance and Quality Control
Laboratory Documentation & SOPs
Process Validation and Monitoring
Environmental Monitoring
Particle Counting
and Water System Management
Microsoft products
Project Coordination in Laboratory and Production Campaigns
Multitasking
Languages
Spanish
English
Timeline
Clinical and Microbiology Laboratory
BC US LLC
02.2025 - CurrentRead More
I+D, Process Development and Production
CIGB
04.2017 - 11.2022Read More
Technological University of Havana CUJAE
from Chemical Engineering
Read More
IPQ: Martires of Giron
High School Diploma
Read More
Events
- 1st Scientific Conference: "Quality management and regulatory affairs in the technological development stage". 2018 Cuba
- BTJ Scientific Conference I: "Purification and solubilization of Hepatitis B virus nucleocapside antigen". 2018 Cuba
- Idifarma: "Alternative to increase contaminant removal capacity in the purification process of Hepatitis B virus nucleocapside antigen". 2018 Cuba
- 7th International Symposium on Pharmaceutical Sciences: "Alternative for purification and solubilization of Hepatitis B virus nucleocapside antigen". 2019 Cuba
- Young Science: "Evaluation of anion exchange chromatography for purification of AgnHb". 2020 Cuba
- Young Science: "Synthesis of immunomodulatory peptide 814 in plant 14". 2020 Cuba
- Young Science: "Analytical characterization of the purity of immunomodulatory peptide 814 purified on an industrial scale". 2020 Cuba
- Science And Technology Forum: "Evaluation of a new alternative for AgnHB purification". 2020 Cuba
- TECMED: "Purification of immunomodulatory peptide 814 on an industrial scale, used against adverse effects caused by covid 19". 2021 Cuba
- TECMED: "Lyophilization of immunomodulatory peptide 814 in plant 14". 2021 Cuba
- Biomanufacturing: "Multilayer filtration as a clarification step in vlp purification protocol". 2021 Cuba
- Biohabana: "Statistical control to assess process consistency and product quality. Case study: Manufacturing of immunomodulatory peptide 814". 2022 Cuba
- Biohabana: "Establishment and adjustments of clean material loads for synthetic peptide (Juzvinza) production. Validation." 2022 Cuba
- Biohabana: "Scaling up purification of immunomodulatory peptide 814 for covid-19 treatment." 2022 Cuba
- Biohabana: "Risk management in the purification stage of the production process of ifa of immunomodulatory peptide 814." 2022 Cuba
- Biohabana: "Evaluation of sanitation and disinfection of immunomodulatory peptide 814 (Juzvinza) production areas." 2022 Cuba
- Biohabana: "Assessment of the effectiveness of new disinfectants for hygiene and disinfection of synthetic peptide production areas." 2022 Cuba
- Biohabana: "Scaling up Production of Immunomodulatory Peptide 814 on a large scale in response to the increasing demand for Juzvinza drug in Covid-19 patients." 2022 Cuba
- BioHabana: "Aseptic Processing and Microbiological Control in The Purification of CIGB 814 Immunomodulatory Peptide." 2022 Cuba
- Science And Technology Forum: "Increase in the Productive Scale of Immunomodulatory Peptide 814 Synthesis." 2022 Cuba
- Proceasep: "Validation of The Process for Obtaining the Active Pharmaceutical Ingredient of Immunomodulatory Peptide 814." 2022 Cuba
- Science And Technology Forum: "Validation of The Process for Obtaining the Active Pharmaceutical Ingredient of Immunomodulatory Peptide 814." 2022 Cuba
- Development of a new purification process for the NS3 protein of vppc, with the study of the influence of biomass washing with 2m urea and 1% triton x100 detergent and 0.005 mol/l imidazole, in cami chromatography as a step for impurity removal. Author 2016
- Evaluation of the purification process of the Hepatitis B virus nucleocapside antigen. Author 2017
- Alternative to Increase Contaminant Removal Capacity in The Purification Process of The Hepatitis B Virus nucleocapside antigen. Author 2017
- Removal of HCP Contaminants from the Cigb550-E7 Protein using a Reduction - Ultrafiltration Procedure. Author 2018
- Quality Management and Regulatory Affairs in The Technological Development Stage. Author 2018
- VII SICF, II Convención Científica Internacional UCLV: "Alternative for the Purification and Solubilization of Hepatitis B Virus Nucleocapsid Antigen". Co-Author 2019
- “El Hacer Médico Necesita Del Pensar Filosófico”. Author 2021
- “Implementación De Un Sistema De Control Estadístico En El Proceso Y La Calidad Del Producto. Caso De Estudio: Fabricación Del Péptido Inmunomodulador 814”. Author 2022
Courses/Training Received
- Biotechnology Course 2017 Cuba
- Immunology Course 2017 Cuba
- Analytical Chemistry Course 2017 Cuba
- Basic Process Purification Course 2017 Cuba
- Preparation of solutions for the purification of recombinant proteins course. 2017 Cuba
- Training in the cell washing, disruption and protein solubilization procedure for proteins. 2017 Cuba
- Training for the obtaining of CIGB550-e7 API. 2017 Cuba
- Training on the operation process of laminar flow. 2017 Cuba
- Training on the operation process of a biological safety cabinet. 2017 Cuba
- Training on the operation process of the extraction hood. 2017 Cuba
- Training for production plant and technological development in the purification process of obtaining proteins. 2017 Cuba
- Basic Production Course. 2017 Cuba
- Basic Good Laboratory Practices (GLP) For I+D Course. 2017 Cuba
- Basic Good Manufacturing Practices (GMP) Course. 2017 Cuba
- Basic Industrial Hygiene and Safety Course. 2017 Cuba
- Training on the purification procedure for ion metal affinity columns. 2017 Cuba
- Training on the purification procedure for hydrophobicity columns. 2017 Cuba
- Training on the purification procedure for ion exchange columns. 2017 Cuba
- Training on the purification procedure for G-25 Columns. 2017 Cuba
- Training in the purification process of Cigb-247 Protein." 2017 Cuba
- I Scientific Conference "Quality Management and Regulatory Affairs in The Technological Development Stage". 2018 Cuba
- Basic Protein Fermentation Course. 2018 Cuba
- Basic Protein Immobilization Course. 2018 Cuba
- Basic Safety and Environment Course. 2018 Cuba
- Basic Good Microbiology Practices Course. 2018 Cuba
- Advanced Biochemistry Course 2019 Cuba
- Peptide Course. 2019 Cuba
- Seminar: Sars-Cov-2: Implications for Prevention and Treatment. 2020 Cuba
- Chemical Safety Course. 2020 Cuba
- Advanced Chemical Analysis Course. 2020 Cuba
- Advanced Clinical Analysis Course. 2020 Cuba
- Advanced Chemical Applications Course. 2020 Cuba
- Advanced Organic Chemistry Course. 2020 Cuba
- Advanced Physical Chemistry Course. 2020 Cuba
- Quality Assurance and Control Course 2020 Cuba
- Basic Genetics Course. 2020 Cuba
- Procedure for Campaign Change in a Peptide Plant. 2020 Cuba
- Procedure for Sampling and Coding of Samples. 2020 Cuba
- Procedure for Batch Naming at Different Stages of The Peptide Active Pharmaceutical Ingredient Production Process. 2020 Cuba
- Safe Handling of Chemical Waste Generated during the Purification Stage. 2020 Cuba
- Flow and Management of Waste. 2020 Cuba
- Flow of Personnel, Material, Solutions, Raw Materials, and Products in Peptides Production. 2020 Cuba
- Procedure for the Purification using Hipersep HPLC. 2020 Cuba
- Procedure for the Purification using Shimadzu HPLC. 2020 Cuba
- Procedure for Determining the Purity Level of Synthetic Peptides using Reverse Phase Chromatography (RP-HPLC). 2020 Cuba
- Seminar on Synthetic Peptide Purification. 2020 Cuba
- Cleaning and Storage of Chromatographic Columns. 2020 Cuba
- Procedure for Operating the Hipersep HPLC Equipment. 2020 Cuba
- Procedure for Operating the Shimadzu HPLC Equipment. 2020 Cuba
- Acquisition and Processing of Chromatographic Data. 2020 Cuba
- Basic Peptide Synthesis Course. 2020 Cuba
- Procedure For Batch Naming at Different Stages of The Production Process of The Active Pharmaceutical Ingredient (API). 2020 Cuba
- Basic English. 2020 Cuba
- Seminar on Environmental Monitoring Program. 2020 Cuba
- Particle Counter Training. 2020 Cuba
- International Course: Cellular And Molecular Biology 2021 Cuba
- International Course: Microbiology 2021 Cuba
- International Course: Advanced Cell Technology for Clinical and Pharmaceutical Industry. 2021 Cuba
- Computer Exam. 2021 Cuba
- Purification Operations at Peptide Plant and Shaping and Sampling Operations at Lyophilization Plant, for the API of Immunomodulatory Peptide 814. 2021 Cuba
- Economics for Technicians Course. 2021 Cuba
- Procedure for the Lyophilization of Synthetic Peptides. 2021 Cuba
- Procedure for Determining the Purity Level of Synthetic Peptides by Reverse Phase Chromatography (RP-HPLC). 2021 Cuba
- Formation of the Batch of Active Pharmaceutical Ingredient of Synthetic Peptide. 2021 Cuba
- Seminar on Methodological Assurance. 2021 Cuba
- Validation and Characterization Protocol of the Production Process. 2021 Cuba
- Descriptive Statistics Course. 2021 Cuba
- Advanced Process Engineering Course. 2021 Cuba
- Advanced Thermotechnics Course. 2021 Cuba
- Advanced Unit Operations Course. 2021 Cuba
- Advanced Mass and Energy Balance Course. 2021 Cuba
- Preventive Measures for Safe Handling of Acetonitrile Waste in Trifluoroacetic Acid with Water. 2022 Cuba
- Conditioning And Entry of Materials, Reagents, And Equipment into Peptides Plant. 2022 Cuba
- Procedure for Sampling and Encoding. 2022 Cuba
- Program for Monitoring Control Parameters in Critical Systems and Auxiliary Systems. 2022 Cuba
- Validation Seminar for Cleaning and Microbiological Control. 2022 Cuba
- CLSI Updates 2025 US
- Training on Operating the Autoclave 2025 US
- Calibration Of Clinical Laboratory Analytes Course. 2025 US
- Microscopic Analysis of Urine Sediment Course. 2025 US
- Chemical Screening of Urine by Reagent Strip Course. 2025 US
- Estradiol, Women’s Health, and The Clinical Laboratory Course. 2025 US
- Normalized Deviance Course. 2025 US
- Biomedical Management Course. 2025 US
- Tracking Unsafe Trends Course. 2025 US
- Fundamentals Of Hemostasis Course. 2025 US
- Antibody Detection and Identification Course. 2025 US
- Describing a Red Blood Cell Population Using RBC Indices and Red Cell Distribution Width Course. 2025 US
- Common Coagulopathies Course. 2025 US
- Blood Borne Pathogen Course. 2025 US
- Hematology Course. 2025 US
- Blood Processing Course. 2025 US
- Introduction to the ABO Blood Group System 2025 US
- Red Blood Cell (RBC) Morphology 2025 US
- Animal Welfare Act Course. 2025 US
- Zoonosis/B Virus Course. 2025 US
- Working Safety with NHPs Course. 2025 US
- Stool Culture Course. 2025 US
- CDC Quarantine Course. 2025 US
- CYNO Course. 2025 US
- Bacteriology Course. 2025 US
- Chemical Management Course. 2025 US
- Vitamin D Course. 2025 US
- Ova And Parasite Course. 2025 US
- Zika Virus Course. 2025 US
- Mosquito-Borne Viral Diseases 2025 US
- The Basic Vaccines and Immunizacion 2025 US
- Transfusion Reations 2025 US
- Current Good Manufacturing Practices for Transfusion Services 2025 US
Publications
VII SICF, II International Scientific Convention: “Alternative for the Purification and Solubilization of Hepatitis B Virus Nucleocapsid Antigen”.
Co-Author 2019
“El Hacer Médico Necesita Del Pensar Filosófico”. https://alfapublicaciones.com/index.php/alfapublicaciones/article/view/110
Author 2021
“Implementación De Un Sistema De Control Estadístico En El Proceso Y La Calidad Del Producto. Caso De Estudio: Fabricación Del Péptido Inmunomodulador 814”.
Author 2022