1 An studious worker and always embrace change positively.
2 Careful and responsible working attitude, able to take the initiative to take on tasks and pay attention to every detail.
Self-assessment
Work Experience
Siemens Healthcare Diagnostics Manufacturing Ltd., Shanghai
Technical Transfer and Operations Specialist
April 2018 - December 2023
- Responsible for the transfer of 11 chemiluminescent immunoassay reagents from the US to China, including technical transfer prior to pilot production, management of pilot production activities, performance evaluation, registration support, and troubleshooting of all technology-related issues during the transfer process. Currently, 3 products have been certified, and 4 products will be submitted for registration in April 2024.
- Technical transfer prior to pilot production: Summarized product design and development, production processes, and release test information based on the DHF and DMR of the products to be transferred. Provided technical training. Assisted MFG and QC in understanding and implementing production processes and release test procedures. Localized risk management docs (dFMEA and pFMEA) based on the actual production situation. Validated the critical process parameters range through DOE design.
- Management pilot production activities: Compiled the pilot production plan. Responsible for troubleshooting and resolving technical issues, including non-conformances, TMD, CAPA. Output the report.
- Performance evaluation:Conducted tests according to PTR and guided QC for registration tests, performed PPE according to CLSI EP for the items in the DIR base on risk analysis (including LOB/D/Q, precision, linearity, specificity, method comparison, OBS, shelf life etc..
- Registration support:generate and explain all technical-related documents during the regulatory review and inspection
- Daily technical operations: assessed technology aspects of non-conformances in daily laboratory, Provided training on testing instruments operations and data analysis software.
- Team management: Led and guided a team of 3 technicians to complete relevant work tasks as a technical expert.
Shanghai Zhicheng Biological Technology Co., Ltd.
Project Leader
September 2016 - April 2018
- Conducted literature search and analysis to prepare biochemical CYC and BMG reagent R & D proposals, developed and implemented individual project development plans.
- Responsible for project data organization and analysis.
- Monitored project progress and cost planning for formulation development.
- Established a platform for raw material testing in laboratory.
Shanghai Sangon Biotech Co., Ltd
Technical Engineer
July 2015 - April 2016
- Provide technical support to molecular cloning and analyzed gene sequences.
- Communicated between customers & laboratory to ensure smooth project progress.
Projects Experience
Chemiluminescence Reagent Production Transfer and Registration
- Management of pilot production activities, prepare the pilot production plan, and participated in troubleshooting production issues and for chemical luminescence reagents: myocardial MYO/CKMB, thyroid function T3/FT3/T4 /FT4/TSH ultra/aTgII, hormone ThCG/FSH/LH/PRGE and tumor markers CEA/CA125.
- Summarized product design and development, and involved in the development and design of PTR and PPE strategies and execute performance evaluation for the above-mentioned reagents.
- Assisted the regulatory department in preparing the above-mentioned reagents registration to meet NMPA requirements and support product come to market.
Research and Development of Biochemical Reagents
- Researched, analyzed data, and formulated plans for the development of biochemical reagents CYC and BMG.
- Screened, evaluated and procured raw materials for biochemical reagents CYC and BMG.
- Developed CYC and BMG reagents using enhanced immune-turbidimetry, including process flow research and performance evaluation of reagents R1/R2, controls, and calibrators.
Skills
Familiar with the whole process of chemiluminescent products from design transfer to complete registration.
Konw well the production process and release test methods of chemiluminescence products.
Familiar with the traceability system and value assignment methods of calibrators and quality controls.
Experienced in handling technical problems occurred in the production process and customer complaints.
Familiar with risk management of products, especially in design and process risk analysis.
Acquainted with the validation of critical process parameters and can utilize DOE tools to complete the related work.
Know well how to design experiments of raw material replacements evaluation for IVD reagents.
Familiar with the Chinese GMP requirements.
Acquainted with the process of non-conformance, temporary deviations, changes, and CAPAs in the quality management system and have the experience to deal with related problems.
Familiar with various guidelines and standards related to in vitro diagnostic reagents.
molecular cloning and protein purification
Proficient in molecular cloning, gene sequencing, protein separation and purification (SDS-PAGE), protein content determination (BCA), and DOE experimental design.
software skills
Proficient in software operation, including Office, MiniTab, DNAMAN, DNASTAR, Primer 6.0, etc.