MICHELLE RODRIGUEZ
Oceanside
Summary
Senior Manufacturing Associate with 5+ years of experience in GMP- regulated biotech manufacturing, specializing in viral vector production, aseptic processing, and process optimization. Proven ability to troubleshoot deviations, improve production efficiency and support high-performing teams in faced-paced environments.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Senior Manufacturing Associate
Kite Pharma
Oceanside
03.2023 - Current
- Demonstrated leadership skills by guiding and directing team members to achieve right-first-time operations for all process steps, maintaining high standards of quality and efficiency.
- Resolved equipment malfunctions and process deviations in cell culture, media formulation, and filling unit operations through effective troubleshooting, ensuring critical parameters remained within established ranges.
- Led Root Cause Analysis (RCA) sessions and utilized analysis tools to identify underlying issues, implementing corrective actions that enhanced process reliability.
- Collaborated effectively with the Manufacturing Science and Technology (MSAT) team, Quality and other teams on process execution, development and document creation for lentiviral vector production.
Manufacturing Technician IV
Kite Pharma
Oceanside
10.2021 - 03.2023
- Conducted manual and automated filling of retroviral vector products, ensuring compliance with cGMP standards and Good Documentation Practices (GDP).
- Adhered to Standard Operating Procedures (SOPs) and maintained thorough documentation to ensure full compliance with commercial manufacturing regulations.
- Completed cross training curricula across manufacturing departments, enhancing process comprehension and increasing flexibility.
- Developed and reviewed process documents, collaborating with departments to implement continuous improvements.
- Achieved Yellow Belt Certification: Stocking Standardization of Chemical Resistant Sleeves to improve operational excellence initiatives and enhance safety-first culture.
Pathologist Laboratory Assistant
Hoag Memorial Hospital Newport Beach
Newport Beach
08.2020 - 10.2021
- Operated cryostat instrument on various organ section types, obtaining precision tissue shavings for accurate microscopic interpretation by pathologist.
- Coordinated with departments and reference laboratories to order diagnostic testing for body fluids and surgical tissues, ensuring timely and accurate results.
- Maintained equipment, organized supply storage, and managed hazardous waste disposal to establish proper laboratory conditions for optimal testing environment.
- Registered patients and accessioned specimens into the EPIC system.
Research and Development Laboratory Technician
Invitrx Therapeutics Inc.
Lake Forest
10.2018 - 02.2020
- Contributed to Investigational New Drug (IND) application for extracellular vesicle product through creation, editing, and review of SOPs, Batch Records, and documentation compliant with FDA regulations.
- Studied regulatory guidelines pertaining to the manufacturing of drugs under cGMP conditions to ensure quality practices.
- Processed birth tissues in cleanroom setting using aseptic technique to isolate mesenchymal cells for further research applications.
- Cultured adherent cell lines by conducting confluency checks, performing media changes, and executing cell passaging.
- Performed cell counts, collected samples and prepared cells for cryopreservation according to company’s protocols.
Education
Bachelor of Science - Microbiology
University of California, Riverside
Riverside, CA01-2018
Skills
- cGMP compliance
- Regulatory Standards
- Cleanroom Operations
- Viral Vector Manufacturing
- Quality assurance
- Process validation
- Process optimization
- Aseptic techniques
- SOP Document Creation
- Instructor-Led Training, Document Creation
- On-the-Job Training Document Creation
- Root cause analysis
- Documentation practices
- Problem solving
Certification
Parenteral Drug Association 800.2: Fundamentals of Aseptic Processing, 06/22, Carlsbad, California
Accomplishments
- End of Year Review - Outstanding Year, 2022, 2024
- MVP01 Q4 2024 Training Star
- Key Contributor Award 2023
- Received over 60 Recognitions from the Gratitude platform
- Kite People Culture Council Representative
Timeline
Senior Manufacturing Associate
Kite Pharma
03.2023 - Current
Manufacturing Technician IV
Kite Pharma
10.2021 - 03.2023
Pathologist Laboratory Assistant
Hoag Memorial Hospital Newport Beach
08.2020 - 10.2021
Research and Development Laboratory Technician
Invitrx Therapeutics Inc.
10.2018 - 02.2020
Bachelor of Science - Microbiology
University of California, Riverside