Rafael Barajas
Los Angeles
Summary
Dedicated scientist specializing in biotechnology, with expertise in quality assurance, microbiology, and process optimization. Successfully facilitated technical transfers, improved manufacturing readiness, and led data-driven initiatives to enhance product performance and compliance. Committed to driving innovation within fast-paced, regulated environments.
Overview
9
9
years of professional experience
Work History
R&D Senior Scientist, Technical Transfer & Process Improvement
Hygiena
Camarillo, CA
01.2024 - Current
- Support technical transfer from R&D to production through process piloting, pilot batch trials, documentation, and tracking critical-to-quality requirements.
- Acted as a technical SME connecting R&D, Quality, and Operations, facilitating technical transfer, improving manufacturing readiness, and driving process improvement initiatives.
- Collaborated with Operations, Quality, Product Management, Customer Support, and R&D to resolve process deviations and enhance product performance and manufacturing processes.
- Lead CAPA and structured root-cause investigations using microbiological, analytical, and statistical data to reduce process variation and support lasting improvements.
- Set up and run lab and floor experiments to assess product and process failures, determine root causes, and confirm corrective actions.
- Apply Lean, Six Sigma, and data-driven problem-solving methods to improve procedures, reduce variation, and increase process efficiency and product robustness.
- Delivered technical training and mentorship to scientists, QC personnel, and cross-functional teams on product procedures, testing methods, and troubleshooting aligned with GMP/GLP practices.
R&D Scientist II
Hygiena
Camarillo, CA
06.2019 - 01.2024
- Developed and rolled out SOPs and QAPs for new product development initiatives, ensuring compliance and efficiency.
- Supported reagent-based manufacturing activities and analytical method development in GMP environments.
- Used HPLC, spectrophotometry, luminometry, and statistical tools to support analytical testing and process improvements.
- Performed advanced microbiological testing, including agar and broth media preparation, ISO/AOAC standard methods, and PCR.
- Conducted root-cause analysis and CAPA investigations to identify quality issues and implement preventive actions.
- Prepared validation protocols, technical reports, and quality investigation summaries for internal and executive review, facilitating informed decision-making.
- Coordinated with quality, regulatory, and operations teams to support development timelines.
- Trained junior scientists and provided support for GMP, GLP, aseptic techniques, and lab best practices.
Quality Scientist
Hygiena
Camarillo, CA
06.2017 - 06.2019
- Qualified raw materials, reagents, and finished products prior to commercial release, ensuring compliance with quality standards.
- Performed microbial assays and bacterial validation testing to verify product performance.
- Prepared reagents under GMP and GLP controls in cleanroom environments.
- Monitored environmental conditions in ISO-classified cleanrooms and laboratory spaces.
- Documented batch production data, deviations, and in-process controls, maintaining adherence to established quality systems.
- Calibrated laboratory equipment to ensure precise measurements., cleaning validation, and preventive maintenance tasks.
- Trained new employees on GMP compliance, SOP adherence, and laboratory best practices to enhance operational readiness.
Education
Bachelor of Science - BIOLOGY
University of La Verne
La Verne, CA05-2016
Skills
- SOP development
- CAPA & Root Cause Analysis
- Microbial Validation & Testing
- ISO standards
- Compliance standards
- Data analysis
- Process optimization
- Process Optimization Management
- Reagent formulation
- Environmental Risk Assessment
- Application of scientific principles
- Research and experiments
- Mentoring skills
- Root cause investigation
Timeline
R&D Senior Scientist, Technical Transfer & Process Improvement
Hygiena
01.2024 - Current
R&D Scientist II
Hygiena
06.2019 - 01.2024
Quality Scientist
Hygiena
06.2017 - 06.2019
Bachelor of Science - BIOLOGY
University of La Verne