Technical Development Scientist 3

Roche • South San Francisco, CA

2d • Onsite

About The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Genentech, a member of the Roche Group! This position is part of Genentech’s Individualized Medicines Team in Pharma Cell and Gene Therapy Group (PTC) responsible for the process development, manufacture and supply of personalized immunotherapies in collaboration with our global partners. The Opportunity We are seeking an exceptional, highly motivated, and technically talented individual to join the Product Attribute Sciences (PAS) team within Analytical Development & Quality Control (ADQC) of the Cell and Gene Therapy unit. PAS is responsible for developing and implementing characterization methods to enable in-depth product understanding and inform the design and refinement of the control system, including QTPP & CQAs, for all cell therapy programs. This is a lab-based role contributing to developing characterization methods (e.g. flow cytometry, ELISA, RT-qPCR/ddPCR, and cell-based potency assays), design and execution of experiments to understand mechanism-of-action (MoA), and generate data to inform decisions to support cell therapy drug development. The ideal candidate will have a background in cell biology, immunology, stem cell biology or related field and will be able to provide scientific and technical judgment as part of a team responsible for delivering high quality cell therapy products to patients. Integrity, accountability, and strong dedication to the patients we serve are critical to this role. Keywords Cell therapy, immunology, cell biology, stem cell biology, chimeric antigen receptors (CAR), RT-qPCR, ddPCR, flow cytometry, cell-based assays/bioassay, potency assays, immunofluorescence, method development

Requirements

• Individuals with excellent experimental skills and proven scientific accomplishments.
• B.S./M.S. degree in the Biological Sciences such as immunology, cell biology, stem cell biology or a related discipline.
• 6+ years of relevant lab-based experience in industry or academia with a focus on CMC/technical development of cell and gene therapy products.
• High level of proficiencies in flow cytometry and cell-based assays/bioassays are required.
• Extensive experience in working with primary cells is required.
• Proficient in statistical analysis and data visualization to support decision-making
• Strong scientific and technical thinking with the desire to learn and troubleshoot challenges.
• Highly collaborative mindset with strong communication skills (both verbal and written), and the ability to effectively present data, write reports and document test procedures.
• High ethical integrity and scientific rigor.

Nice To Haves

• Strong familiarity with ICH Guidelines with related Method Development experience is preferred.

Responsibilities

• Develop, implement, and execute testing for assays with a wide range of readouts, including flow cytometry, ELISA, ddPCR/RT-qPCR, cell-based assays/bioassays, etc.
• Independently or with minimal supervision design and execute experiments focused on identifying drivers of MoA for cell therapy drug products.
• Generate high-quality data to enable data-driven decision making in support of cell therapy drug development.
• Characterize cell therapy drug products by cell surface marker expression, molecular biology techniques & cell-based assays/bioassays.
• Ability to work with primary cell culture.
• Support data analysis/management and maintain accurate records of research using electronic lab notebook (ELN) platform.
• Write development/technical reports, SOPs and test procedures.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees