Sarahi Perez
Whittier
Summary
Cell therapy specialist with strong foundation in GMP, aseptic processing, and regulated biotechnology manufacturing. Experienced in executing and supporting cleanroom operations, environmental control and documentation workflows in highly compliant settings. Skilled in PAS-X, LIMS, Oracle, deviation support, and SOP authorship/ownership. Detail oriented, focused on consistency, and process improvements.
Overview
6
6
years of professional experience
Work History
Production Team
Kite Pharma - Manufacturing department
06.2022 - Current
- Qualified aseptic operator responsible for cell processing and cell expansion for the manufacture of CART T cell therapy products.
- Performed manufacturing processing using laboratory automated cell separation systems, including SEPAX C-Pro processing instruments and CliniMACS Plus instruments.
- Perform batch record reviews and support leadership in processing floor with troubleshoot equipment and resolving issues.
- Assisted with regulatory agency audits by FDA, European Medicines Agency, and Therapeutic Goods Administration and internal audits for Yescarta.
- Document revisions to address CAPAs from internal audits findings.
- GVault QDMS Owner/Author to perform SOP workflow and edits to provide alignment and instruction to address CAPAs and changes implementation.
Production Support Team
Kite Pharma - Manufacturing department
07.2019 - 01.2022
- Qualified aseptic operator responsible for Cell culture media preparation associated with the manufacturing of commercial product following batch records and SOPs in accordance with GMP and GDP standards.
- Experienced using PAS-X, an electronic manufacturing execution system.
- Experienced using Oracle EBS for enterprise resource planning.
- Organized patient products stored in liquid nitrogen freezers and performed the discard of expired products.
- Perform visual inspection of the final product.
- Experienced using LabVantage Library Information Management System (LIMS).
Education
Bachelor’s of Science - Biology (Microbiology emphasis)
Humboldt State University (HSU)
Arcata, CA05.2019
Skills
- Read, write and speak English
- Read, write and speak Spanish
- Microsoft Office(Word, Excel and Powerpoint)
- Excellent communication and organizational skills
- Collaborative and teamwork skills
- Loyal and dependable–strong work ethic
Accomplishments
- EM plate project identified manufacturing discards over 1200 environmental plates per month, with the cost of process waste leading to $30,000 per month. Implementation of EM plate handling and storage methods led to the use of only necessary number of plates for processing.
- Contributed to data collection to benefit the MFG department through the BCP document preparation in case of outages. Veeva vault BCP project Data retrieval helped create organization of all MFG documents to access virtually within veeva vaults as part of the Business Continuity process (BCP).
- Participate in 2024 Global Tech Ops Operational Excellence Poster sessions on EM plate cost reduction project
- Shift trainer assessment to train CTS in aseptic gowning qualifications for ISO8 and ISO7 environments, use of laboratory automated cell separation systems and Cell count and sampling requalifications training.
Timeline
Production Team
Kite Pharma - Manufacturing department
06.2022 - Current
Production Support Team
Kite Pharma - Manufacturing department
07.2019 - 01.2022
Bachelor’s of Science - Biology (Microbiology emphasis)
Humboldt State University (HSU)