QC Scientist, Global Analytical Science & Technology

United States, California, South San Francisco

Location:  South San Francisco, CA

 

Please note relocation is not available for this position.

 

Who We Are

At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

Position Summary:

The successful candidate will join Global Analytical Science and Technology (gASAT) within Roche global QC network. gASAT department provides scientific/technical support to the Roche QC Network for the entire commercial biologic product portfolio, drives productivity, agility and innovation in QC, contributes to QC testing time reduction and supports fast time of novel medicines to our patients. 

 

The department manages and aligns methods and control systems across the Biologics Operating Unit during launch and post-approval, and is accountable for lifecycle management of analytical methods & specifications for commercial biologic products, as well as commercial reference standard program.

 

gASAT Analytical Chemistry and Bioassay department is seeking a senior QC associate or QC scientist to join the gASAT Analytical Chemistry staff and serve as global QC network analytical method subject matter expert (SME). We are looking for a lab scientist who is hands on and passionate about solving problems and making a difference through scientific lab work and cross-functional, cross-site collaboration.

 

The candidate will provide analytical method expertise in analytics of therapeutic proteins and monoclonal antibodies to Roche commercial QC network, drive network initiatives including standardization, automation and new technology introduction. The candidate will also monitor commercial method performance  and provide method improvement and troubleshooting support to the QC sites.

Job Duties/Responsibilities

• Develop and execute plans for the development, optimization, validation, implementation and maintenance of QC test methods for commercial biologic products following cGMP regulations, regulatory guidelines as well as local and global quality standards

• Lead investigations across the entire Roche/Genentech global QC network (including CMOs and partners)

• Apply technical knowledge, scientific experience and expert judgment to address a broad range of difficult analytical problems

• Troubleshoot and direct the resolution of QC method issues by fostering effective interdepartmental and cross-functional partnerships

• Design and execute studies to assess technical suitability of new technology in QC environment

• Author technical study protocols/reports and method validation protocol and reports with minimal supervision

• Serve as an analytical method SME, response to health authority questions on methods

• Own global methods and serve as change owner for global method release and revision

• Monitor method performance in the QC and implement improvement measures to enhance QC Right First Time rate

• Support Analytical Technical Leaders for product control system life cycle management

• Spend approximately 50% of the time in the lab, and work on site during normal business hours to ensure adequate interaction with other lab staff and management, and execution of lab studies