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Staff Scientist
7 months ago
The Opportunity
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
Responsible for Microwell Assay development team in China, including raw material selection, formula design and optimization, and product registration
Responsible for preparation of product registration dossier in accordance with the requirements of the design control processes.
Assist in product registration activities, such as type testing, clinical trials, and quality inspection
Assist in the establishment, implementation and improvement of platform technology and department-related process of China R&D Department
Request：
Natural science major background, preferred biological, pharmaceutical, or medical related major
Requires BS with 10-15 years of experience; Masters with 8 to 10 years or preferable PhD with more than 5 years of immunoassay development experience
Hands-on development expertise in immunoassay development demonstrated through multiple years experience and positive track record of development of marketed immunoassays .
Proficient in English and Mandarin spoken and in writing. Understanding nuances of US and China cultural differences.
Individual have made strong technical contributions that are substantiated by a track record of commercialized products.
• research experience in immunoassay concepts and technologies. Track record of product development in Immunochemistry and clinical background in any indication like Cardiac, Metabolic, Oncologic and/or Infectious Disease.
• Previous experience in experimental design and analytical analysis, including data evaluation and interpretation is required.
• Basic computer skills (MS Word, MS Excel) along with experience in MiniTab or other statistical software is desired.
• Experience with evaluation and statistical analysis using methods such as the CLSI documents is preferred.
• Individual must be bilingual and have good written and oral communication skills in English and Mandarin and a demonstrated ability to work in an interdependent, collaborative, cross-cultural environment.
• experience in Antibody/antigen selection, modification, purification is desired
