Senior Development Scientist

1 day ago

Shanghai, Shanghai, China Ortho Clinical Diagnostics Full time

About the Opportunity

At Ortho Clinical Diagnostics, we are committed to transforming the power of diagnostics into a healthier future for all. As a world-leading in vitro diagnostics company, we unite the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine.

We are more than 6,000 strong and operate in over 130 countries, providing fast, accurate and consistent testing where and when it is needed most – from home to hospital, lab to clinic.

In this role, you will be responsible for leading the Microwell Assay development team in China, including raw material selection, formula design and optimization, and product registration.

You will work closely with cross-functional teams to prepare product registration dossiers in accordance with design control processes and assist in product registration activities such as type testing, clinical trials, and quality inspection.

This is an exciting opportunity to join our mission-driven organization and contribute to the establishment, implementation and improvement of platform technology and department-related processes of the China R&D Department.

Responsibilities:

  • Lead the Microwell Assay development team in China to deliver high-quality products
  • Develop and implement strategies for raw material selection, formula design and optimization
  • Prepare product registration dossiers and ensure compliance with regulatory requirements
  • Assist in product registration activities, including type testing, clinical trials and quality inspection
  • Collaborate with cross-functional teams to establish and improve platform technology and department-related processes

Requirements:

  • Natural science major background, preferably biological, pharmaceutical or medical related
  • BS with 10-15 years of experience; Masters with 8 to 10 years or 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 written, with understanding of cultural nuances between US and China
  • Demonstrated ability to work in an interdependent, collaborative, cross-cultural environment

Estimated Salary:$120,000 - $180,000 per annum, depending on experience

About Us:

We put our team members first and prioritize actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other, recognizing that employee happiness and business success are linked.

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