Technical Development Scientist, Cell Banking

Genentech's Cell Banking organization is seeking a highly motivated cell culture Technical Development Senior Scientist to support various aspects of R&D and GMP Cell Bank development and production. The Cell Banking group is responsible for generating cell banks in support of both clinical and commercial drug substance manufacturing. In addition, the Cell Banking group is monitors, troubleshoots, and improves the Cell Banking processes in both the R&D and GMP environment. The work also includes providing scientific and technical judgment as part of a team responsible for delivering high quality biopharmaceutical products to patients. Integrity, accountability, and strong dedication to the patients we serve are critical to this role.

What You'll Do

Data Analysis & Process Optimization:

• Analyze key performance indicators (KPIs) such as specific growth rate, cell viability, and other relevant metrics from CHO cell culture experiments.

• Utilize advanced statistical techniques (e.g., regression analysis, hypothesis testing, trend analysis) to identify performance trends, root causes, and potential improvements.

• Execute experiments focused on improving process robustness and productivity to meet the evolving needs of the Cell Banking organization.

Report Authoring & Collaboration with Quality Assurance:

• Prepare comprehensive reports summarizing the results of data analysis, trends, and actionable insights.

• Collaborate with the Quality Assurance team to ensure reports meet regulatory standards and are reviewed and approved in a timely manner.

• Support the documentation and creation of discrepant events, investigations, and change records as needed.

Compliance & Documentation:

• Adhere to all applicable safety and compliance standards, including cGMP (current Good Manufacturing Practices), SOPs, and other relevant manufacturing documents.

• Ensure that all work complies with regulatory requirements and internal procedures for process validation, investigations, and documentation.

• Provide ongoing support for regulatory inspections and filings, ensuring that data and processes are compliant with industry standards.

GMP Operations Support:

• Support GMP operations and contribute to maintaining a compliant, efficient, and safe manufacturing environment.

Who You Are

• Bachelor's degree in Cell Biology, Biotechnology, Bioengineering, or a related field. A Master's degree or higher is preferred.

• At least 2-3 years of experience in cell culture or bioprocessing, particularly with CHO cells.

• Strong experience with data analysis in a biotech or pharmaceutical environment, including the use of statistical tools (e.g., Excel, R, Python, Minitab).

• Familiarity with cGMP practices and regulatory requirements in a biomanufacturing environment. Prior experience supporting GMP operations is highly desirable.

• Experience in process optimization and the implementation of engineering or operational improvements in a biotech manufacturing setting is a plus.

Skills:

• Proficient in statistical analysis and data visualization to support decision-making and process improvements.

• Strong understanding of cell culture processes, particularly CHO cell lines, and how they relate to productivity, yield, and viability.

• Excellent communication skills, both written and verbal, with the ability to present data and insights clearly and effectively to cross-functional teams.

• Ability to work independently and as part of a collaborative team, hand

Additional Qualifications:

• Knowledge of process control systems and data management tools used in the biotechnology and pharmaceutical industries.

• Familiarity with Change Control, Risk Management, and Corrective Action/Preventive Action (CAPA) systems is a plus.

Relocation funding is not available for this role.

The expected salary range for this position based on the primary location of South San Francisco, CA is $84,600 - $157,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.