QC Scientist, Global Analytical and Science Technology
Join a Team that Lives to Improve Lives
People come to Genentech from across disciplines and across the world to solve our most challenging medical conditions. You’ll find inspiration in our passion for biotechnology, our purpose to positively impact the lives of millions of patients and our dedication to our people. Joining Genentech means being part of a tradition of inquiry that will change the world. It means embracing our failures as much as our successes. It requires a willingness to look beyond the edge of what's possible. And a focus on doing the day-to-day work that makes great science happen.
The following opportunity exists in our South San Francisco, CA headquarters:
QC Scientist, Global Analytical and Science Technology
Please note relocation is not available for this position.
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.
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.
• 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
Who You Are
• Has in-depth knowledge, hand on experience and expertise on biologics drug substance and drug product analytical methods including scientific theories, principles and techniques
• Able to work with QC labs across QC network to trouble shoot iOOS and other technical issues of the methods
• Able to address HA questions in the methods with limited direction and supervision
• Able to performing method development, improvement, validation and GMP testing
• Knowledgeable of and experienced in cGMP, compliance, and regulatory requirements for biopharmaceuticals
• Experience with Labware LIMS, Trackwise, Change Control and other quality systems, can be CAPA and CR owner with minimal direction
• Strong written and verbal communication skills with proven record in protocol, report and deviation/CAPA writing
• Highly motivated and self-driven i with the ability to work with minimal supervision to schedule, track, review, and report progress
• Excellent resource and task planning and prioritization skills with the ability to deliver high quality results per planned timelines
• Knowledge of and experience with cGMP, compliance, and regulatory requirements for biopharmaceuticals are required
• Able to work in the lab approximately 50% of the time, and able to work on site at normal business hours
• B.S. or M.S (preferred) in Analytical Chemistry, Physical Chemistry, Biochemistry or other relevant fields with minimal of 5 years experience in pharmaceutical, diagnostic or other GMP regulated industries.
A Job with Benefits Beyond the Benefits
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
Apply Link: https://www.gene.com/careers/detail/3410942919/QC-Scientist-Global-Analytical-Science-Technology