# Trevin Fei > Biotech Professional Location: Concord, California, United States Profile: https://flows.cv/trevin ## Work Experience ### Senior Manufacturing Associate @ Amgen Jan 2025 – Present ### Senior Manufacturing Associate @ Bayer Jan 2025 – Jan 2025 ### Senior Manufacturing Associate @ Amgen Jan 2024 – Jan 2025 ● Initiated, tracked, and managed Corrective and Preventive Action (CAPA) processes from identification to resolution, ensuring timely and effective issue resolution. ● Collaborated with cross-functional teams to investigate root causes, develop corrective and preventive actions, and implement solutions to prevent recurrence of issues. ● Monitored CAPA progress and ensured that actions were completed within established timelines, maintaining compliance with industry regulations and internal standards. ● Designed, developed, and implemented a custom project management tool in Smartsheets to streamline workflow, improve team collaboration, and enhance project tracking of Drug Substance Manufacturing. ● Created a database and reports within smart sheets for projects below $25000 to consolidate best plant metrics of Cost Savings, Cost Avoidance, and Sustainability. ● Assisted in the development standardized risk management plan templates. ● Assisted in the Manufacturing Epogen Product following GDP and SOP Guidelines. ### Manufacturing Associate 3 @ UCLA Health Jan 2024 – Jan 2024 -Writing and Initiating IR, Deviations, CAPAs, Change Controls, OOS, Job Aide Construction -Creating Equipment Specific SOPs involving Troubleshooting, Primary Maintenance, Cleaning -Creation of OJT and Training systems for Manufacturing: CAR-T, Aseptic Technique, Media Fills -Batch Master Record Creation and Implementation -Tech Transfer and Onboarding of new manufacturing instrumentation -Upstream manufacturing of stem cells using Amniotic Membrane from Placenta -lead trainer for centralized manufacturing staff. ### Manufacturing Associate II @ Capricor Therapeutics, Inc. Jan 2022 – Jan 2022 - Aseptic Gowning and Aseptic Technique - Downstream Activities: Fill Finish into glass vials with visual inspection and labeling. - Upstream Activities: Seed Train in Cell Factory, Expansion into Flasks, Adherent Cell Culture - Initiating Deviation, Deviation Investigation, and Deviation Closures - Intiating, Writing, and Closing of OOS, IR, CAPAs - Change Controls - Batch Record Review - Lead trainer ### Manufacturing Associate Upstream and Downstream @ Astellas Gene Therapies Jan 2020 – Jan 2022 | San Francisco Bay Area - Experience in cGMP and cGDP Facility - Downstream Activities: TFF Skid, Ion Exchange Columns, Buffer Preparation - Upstream Activities: Seedtrain, 200L to 500L Bioreactor, Transfection, Aseptic Technique, and Aseptic Gowning - Upstream: Adherent Cell Cultures: Thaw, Media preparation, Innoculation of ULA, Nunc-Triple Flasks - Initiating Deviation, Deviation Investigation, and Deviation Closures: Both IR and Non-Conformance - SOP Revision and Creations - Batch Record Review - Shift Lead and Primary trainer for Upstream Practices ### Research Associate @ Intrexon Corporation Jan 2018 – Jan 2020 | South San Francisco, California - Turned around, calibrated, monitored, and troubleshooted weekly fermentation experiments used for strain screening, performance , and evaluation on a Micro (Single Use), 1L, 5L, and 500L (Steel) scale. -Worked with process engineers to troubleshoot for the 500L Pilot Plant tank: evaluated metrics including Mass Transfer, KLA, MUR, OUR, CER, and strain performance for production of Bio Mass and 1,4 Butanediol. - Increased efficiency of fermentation media production through reorganization of fermentation medium and batch record restructuring. - Ran medium optimization experiments to reduce chemical waste, eliminate component solubility issues, and to help increase strain productivity. - Used aseptic technique to run sample checks on tank sterility, optical density, RNA Sequencing, and Proteomics. - Organized tank construction workflow towards Good Lab Practice standards. ### Fementation Media Technician @ Zymergen, Inc. Jan 2017 – Jan 2018 | Emeryville • Produced custom and stock media to meet end-user specifications. • Washed, decontaminated, and sterilized lab fermentation tanks and glassware using Steris, Yamato, and Tuttnauer Autoclave. • Input chemical compositional data into batch records and uploaded the data into LIMS. • Managed inventory for fermentation, custom, and stock media chemicals using NetSuite database systems. • Produced and onboarded fermentation medium for weekly fermentation runs. • Trained employees on the fermentation media production process. • As lab room owner, built up safety protocol for the fermentation media laboratory. ### QA/QC Chemical Analyst (contract) @ Napa Sanitation District Jan 2016 – Jan 2017 | Napa California - Collected wastewater, stream, soil and industrial waste samples for analysis both in the field and in the treatment plant. - Maintained routine sample documentation and logistics: sample handoff (chain of custody forms); recorded sample collection, quality analysis, and test results in both LIMS and daily data log sheets. - Performed and analyzed quality control and assurance checks on wastewater, ground water, biosolids, and industrial waste samples. (regulatory TSS, Process TSS, Residual Chlorines, BODs, DO, PH, Micro Colilert, Alkalinity, AB Sour, Pond LDOs, Temperature) ### Quality Assurance Technician @ Miller Milling Company Jan 2015 – Jan 2016 - Utilize knowledge of food science to analyze and test wheat & flour samples to ensure compliance with customer specifications. - Performed chemical and physical testing of supplier wheat and flour samples for in-process ingredients, cross check samples, and in-process and finished product. - Regularly updated and maintained COA database and document control for audits. - Assisted QA manager and team lead with customer complaints and requests. - Ran numerous quality control checks on flour samples: using a Boerner Divider, Falling Number, DON test, Farinograph, Foss NIRS monochromator, Mixograph, Moisture Oven, Ash Furnace, PH meter, Temperature probe, ROTAP Sieve Shaker Machine. ### Marketing and Logistics At VMCS (Veterinary Medicine Central Services) @ Vet Med Central Service Jan 2013 – Jan 2014 | UC Davis -Maintained excellent customer service at all times. -Ensured Merchandise presentation was in accordance with company standards. -Stocked shelves and made sure work area was tidy. -Received and verified department deliveries. -Created a Customer First environment through proper sales floor and backroom presentation standards -Cautiously Worked with Various Lab Media (Beakers, Oligosaccharides, Primers, Test tubes...Etc) -Made sure delivery vehicle was clean and safe. ### Davis Community Meals @ Davis Community Meals Jan 2011 – Jan 2011 | Davis, Ca -Served meals to less fortunate individuals weekly -Set up large scale dining environment -Practiced culinary arts in a large scale environment ### Clerk @ Advanced Medical Pharmacy Jan 2010 – Jan 2010 | Walnut Creek, CA -Entrusted with the oversight of all financial transactions during open hours -Resolved many complications between customers and insurance companies -Tasked with accurately labeling prescriptions in accordance with strict, government standards -Organized prescription medications, thus expediting the distribution process ## Education ### Nutrition science in Biochemistry University of California, Davis ### UX/UI Design CareerFoundry ### Project Management Coursera ## Contact & Social - LinkedIn: https://linkedin.com/in/trevin-fei-57679b2a --- Source: https://flows.cv/trevin JSON Resume: https://flows.cv/trevin/resume.json Last updated: 2026-04-13