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Job Summary:
The owner of the position is responsible for:

leading a team in the development of in vitro diagnostic assays in Suzhou, China; 

overseeing the design, development, and optimization of new assays, as well as the improvement of existing products;

providing technical guidance and expertise to ensure the successful execution of projects, including managing timelines, resources, and budgets;

plays a crucial role in team management and staffing projects, assigning roles, and fostering the professional development of team members; 

providing leadership, mentorship, and support to ensure the team's success in meeting project deliverables and goals;

Ensuring a strong collaboration with cross-functional teams, including regulatory, quality, and manufacturing, is essential to drive the successful development and launch of IVD assays.

Main Tasks & Responsibilities:

Takes on the responsibility for the development of immunological IVD assays registered out of Suzhou, including reagents, calibrators, and controls, with a focus on developing new products and product updates. 

Represents Suzhou development in project teams, where R&D concepts are developed and solutions are derived accordingly.

Advises these project teams and ensures close coordination with relevant global functions. Supports global regulatory approval processes through collaboration with relevant functions on project content, timelines, budgets, and new approaches to evidence generation. 

Possesses deep and broad expertise in their area of specialization and has a good knowledge of higher-level areas of responsibility.

Optimizes local development processes to improve the efficiency, effectiveness, and time-to-market of future products. 

Ensures strong interfaces with all sub-chapter leads within the R&D Suzhou chapter, as well as other involved R&D units such as global assay development, RRD, and CSI. 

Engages in interaction and communication with all relevant interfaces of local/global functions and teams within the Core Lab framework, including life cycle teams, project management, CDMA, manufacturing, Q&R, and external collaboration partners. 

Plays a fundamental role in interacting with local manufacturing units and other global functions at the Suzhou site, particularly in relation to planning and executing development projects.

Staffs projects according to discussed and agreed-upon priorities and requirements with the project governance structures (global R&D and Life Cycle Teams). 

Plans resources within their sub-chapter, assigns roles, and trains and develops personnel in accordance with valid regulations. Provides leadership and support to direct reports to optimize their capability in successfully contributing to project deliverables. 

Responsible for adhering to the schedule and budget of R&D projects/programs, proactively managing risks in coordination with appropriate functions, and providing updated project status reports to adjacent areas and decision-makers. 

Reviews all R&D documentation/reports and milestone documents within their own sub-chapter for content, quality, and consistency.

Qualification & Experience

PhD or Master degree in natural sciences, preferably in biology, biochemistry, clinical chemistry or related subjects

Business fluency in Chinese and English, oral and written 

7-10 years of experience in the clinical laboratory testing and development of IVD assays, preferably immunology assays

A solid knowledge of IVD manufacturing and/or product care activities is beneficial

Leadership experience in an R&D or clinical laboratory setting

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.