Yucheng Guan
Process Development Associate
Irvington,NJ
Summary
Hailing from China at the tender age of 11 by an off chance, I was able to pick up a new language and juggle family obligations while observing and learning the nuisances of American culture. Tackling whatever came my way I was able to persevere through the thick and thins of social stigma while keeping up with academic, office, and lab duties while maintaining a blank attitude of blank.
Overview
6
6
years of professional experience
8
8
years of post-secondary education
1
1
Language
Work History
Process Development Associate
Celularity
Florham Park, NJ
02.2021 - Current
- Supported and execute studies conducted for process optimization to meet regulatory and process transfer requirements
- Developed training modules and conducted training activities in support of manufacturing process optimization
- Generated prototypes and testing samples by using aseptic processing techniques and bioengineering laboratory equipment
- Coordinate with logistics team to ensure the shipping and delivery of testing samples to be analyzed
- Manage the inventory of processing supplies and coordinate with warehouse personnel to ensure the continuity of processing supplies for product development activities; Source materials from outside vendors when needed
- Provided logistical support for team members and simple troubleshooting for delays in the supply chain
- Discussion and collaboration with associates to ensure the efficient use of time, lab space, and lab equipment. Discussion and analysis of operating constraints with associates such as the supply of critical processing raw materials and root-cause analysis for non-conforming testing data
- Review and finalize standard operating procedures and batch records.
- Presented processing data and analytical results to management and team to discuss and address non-conformances as a team
- Provided training and process onboarding support for new associates.
Technical Training Associate, CAR-T Manufacturing
Novartis Corporation
East Hanover, NJ
10.2019 - 02.2021
- Conducting instructor lead courses in cleaning and operation of manufacturing equipment, pipetting and review of GMP data.
- Guided trainees for on-the-job trainings and qualification assessments on processing manifold assembly and solution transfer in closed systems; pipetting and operation of the NC-200 cell counter
- Lead and coordinated activities on training batch record creation, verification, delivery, review, and archiving.
- Optimized process flow for efficiency to ensure batch records are created and delivered on time.
Quality Control Inspector II
LifeCell Corporation, Abbvie, Formerly Allergan
Branchburg Township, NJ
10.2017 - 10.2019
- Inspection of incoming raw materials used for cleanroom processing
- Utilized ANSI/ASQ Z1.4 sampling plan for random sampling of material for inspection
- Tracked and trended weekly process flow and metrics using Microsoft Access and Excel and communicated process hurdles to supply chain management
- Collaborated with procurement for obtaining quality certifications; Used TrackWise and collaborated with operations, packaging, quality, and supplier engineering for clearing holds on inventory due to non-conformances or supplier issues
- Acted as a QC raw materials SME in deviation investigation and raw material specification updates
- Worked with New Product and Technology’s team to align supplier documentation with specification requirements in development
- Supported implementation activities of change controls on material specification updates and ERP system transition
New Product and Technology Introductions Support (Intern)
LifeCell, Abbvie, Formerly Allergan
, NJ
01.2019 - 06.2019
- Shadowed equipment qualifications and trained processing technicians in using new processing components as a part of the process performance qualification.
- CAD modeling of perforated templates and dies using Solidworks.
- Executed investigative engineering studies on failure modes of new packaging component, conducted root cause analysis using a 6M approach.
- Performed ANOVA and T-tests using Minitab on tissue thickness studies over time.
Manufacturing Technician II
LifeCell Corporation, Abbvie, Formerly Allergan
Branchburg Township, NJ
02.2016 - 09.2017
- Aseptic processing of human tissue in class 100 controlled environment under cGMPs.
- Coordinated and executed production schedule and tasks with group lead and technicians with minimal supervision.
- Trained new technicians on aseptic technique and manufacturing processes in tissue splitting and washes.
- Participated in 5s and Kanban projects and aided with its implementation.
- Trained on GMPs, GLPs, GDPs, aseptic technique and FDA compliance regulations.
Education
Masters of Science - Mechanical Engineering
New Jersey Institute of Technology (NJIT)
01.2017 - 01.2021
Bachelor of Science - Biomedical Engineering
Rensselaer Polytechnic Institute (RPI)
Troy, NY 08.2011 - 06.2015
Skills
Dependable and Responsible
Analytical and Critical Thinking
Attention to Detail
Accomplishments
- Certifications: Six Sigma Green Belt.
Timeline
Process Development Associate
Celularity
02.2021 - Current
Technical Training Associate, CAR-T Manufacturing
Novartis Corporation
10.2019 - 02.2021
New Product and Technology Introductions Support (Intern)
LifeCell, Abbvie, Formerly Allergan
01.2019 - 06.2019
Quality Control Inspector II
LifeCell Corporation, Abbvie, Formerly Allergan
10.2017 - 10.2019
Masters of Science - Mechanical Engineering
New Jersey Institute of Technology (NJIT)
01.2017 - 01.2021
Manufacturing Technician II
LifeCell Corporation, Abbvie, Formerly Allergan
02.2016 - 09.2017
Bachelor of Science - Biomedical Engineering
Rensselaer Polytechnic Institute (RPI)
08.2011 - 06.2015