Luyun (Lauren) Yang Email & Phone Number

Los Angeles, Ca, Us

Tokyo, Jp

- Provide 24/7 support for daily manufacturing including cell culture, purification, and formulation/filling area. Trouble shooting, determining root cause and providing optimal solutions for equipment and process related issues.- Currently system owner for bulk manufacturing purification equipment and lyophilizers. - Support capital project executions for various equipment including filling line, lyophilizers, chromatography skids, columns, TFF skids. Recently led activities for old suite decommission and new suite design review and modifications.

Bethlehem, Pa, Us

• Support Daily Manufacturing and deviation investigations for IV bags. • Optimize manufacturing process, update SOP and batch records.

Thousand Oaks, Ca

Client: Amgen• Qualify new equipment and processes for manufacturing process- Autor and execute protocols for new isolator filling line and lyophilization equipment and processes qualifications- Design experiment for system robustness/capability studies and analysis experiment results with JMP and R Studio- Contact vendors and support PM activities• Scale up new lyophilization processes from lab scale to pilot scale with computer model assistance

• Transfer new parental products from lab to clinical manufacturing - Designed equipment setup and purchased new equipment/components for different new processes for bulk manufacturing and aseptic filling including: crystallization, size reduction, filtration (hollow fiber, UFDF, bioburden, sterile), liposome preparation, single use designs. - Authored and executed protocols for new process validation and equipment validation- Created and updated Batch Records, SOPs, BOMs • Support existing cleanroom manufacturing activities- Conducted root cause analysis, generated deviation reports and CAPAs for manufacturing nonconformance- Coordinated FMEA for bulk manufacturing process, ISO 5 filling process and process equipment- Initiated change controls for existing manufacturing process to improve efficiency and compliance - Developed equipment PM procedures based on manufacturing usages

Irvine, Ca, Us

Processed Ge-based heterostructure nanocrystal thin film with good thermoelectric property.Designed novel metal deposition methods on silicon nanowire in oxygen-free organic bath;Improved wires’ thermoelectric property by controlling micro heterostructure; Utilized material characterization device: SEM, EDS, XRD

Irvine, Ca, Us

Helped students improve scores in general chemistry and inorganic chemistry

YTO Group Corporation is the first tractor factory in China. This internship helped me to get familiar with common manufacturing processes: heat treatment, casting, forging, wielding.

Master'S Degree, Materials Science

Bachelor Of Engineering (Beng), Materials Science