Herly Salazar
Reads Landing
Summary
Experienced Biomanufacturing Engineer and Medical Laboratory Scientist with 17 years in cell therapy manufacturing and GMP operations. Skilled in aseptic processing, cell culture, and environmental monitoring for clinical trials. Specializes in process development, equipment troubleshooting, SOP development, and quality control testing in regulated environments.
Overview
20
20
years of professional experience
Work History
Medical Laboratory Scientist
Quest Diagnostics
06.2025 - Current
- Conducted moderate and high complexity diagnostic tests, ensuring accuracy and timely reporting.
- Executed phlebotomy and point-of-care testing, ensuring adherence to laboratory policies and safety standards for optimal patient care.
- Monitored and troubleshot laboratory instrumentation and test systems, enhancing operational efficiency and reliability.
- Performed instrument calibration maintenance and quality assurance checks, supporting regulatory compliance and accuracy in test results.
- Documented laboratory data and quality control results following established documentation practices.
Advanced Biomanufacturing Engineer
Mayo Clinic
05.2020 - 06.2024
- Produced mesenchymal stromal cells and dendritic cells for Phase I and II clinical trials under CGMP conditions.
- Executed aseptic processing in sterile cleanroom environments for clinical-grade cellular therapeutics production.
- Monitored cell culture expansion and analyzed microscopy results to assess cell growth and viability.
- Conducted laboratory testing using automated DNA extraction, real-time PCR, flow cytometry, and spectrophotometry.
- Performed sterility testing and environmental monitoring to ensure GMP facility compliance.
- Optimized media storage, reagent usage, and inventory management to enhance operational efficiency in biomanufacturing processes.
- Maintained and troubleshot biomanufacturing equipment along with laboratory instrumentation.
- Collaborated with quality control and technical teams to resolve assay and equipment challenges, ensuring compliance with GMP standards.
Clinical Laboratory Scientist
Mayo Clinic
06.2007 - 05.2020
- Conducted diagnostic testing on blood and urine specimens in Chemistry, Hematology, Immunology, and Coagulation laboratories, contributing to accurate patient diagnoses.
- Maintained quality control procedures and conducted instrument maintenance to ensure accurate and reliable test results.
- Trained and mentored new laboratory staff and students on laboratory instrumentation and protocols, fostering a knowledgeable and efficient team.
Clinical Laboratory Assistant
Mayo Clinic
09.2006 - 05.2007
- Accessioned and tracked specimens for hematology and molecular testing to ensure accurate analysis.
- Prepared microscopic slides and performed staining and processing to support timely diagnostic results.
- Delivered laboratory test results to physicians, facilitating informed patient care decisions.
Education
Bachelor of Science - Clinical Laboratory Science
University of Wisconsin – Stevens Point
05-2007
Skills
- CGMP and GMP manufacturing
- Aseptic processing and cleanroom operations
- Cell culture and bioproduction
- Process development and scale-up
- Environmental monitoring
- Quality control testing
- Flow cytometry and real-time PCR
- Automated DNA extraction
- Sterility testing
- Equipment maintenance and troubleshooting
- SOP and batch record documentation
- Inventory and reagent management
- Laboratory validation and compliance
- Cross-functional collaboration
Community Service
- Volunteer – Salvation Army Good Samaritan Health Clinic
- CareFest Volunteer
- United Way Advocate
- Blood Drive Coordinator
References
Available upon request.
Timeline
Medical Laboratory Scientist
Quest Diagnostics
06.2025 - Current
Advanced Biomanufacturing Engineer
Mayo Clinic
05.2020 - 06.2024
Clinical Laboratory Scientist
Mayo Clinic
06.2007 - 05.2020
Clinical Laboratory Assistant
Mayo Clinic
09.2006 - 05.2007
Bachelor of Science - Clinical Laboratory Science
University of Wisconsin – Stevens Point