Technical Development Scientist II - Analytical Development

Roche•San Diego, CA

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! The Opportunity We are seeking an experienced and motivated Technical Development Scientist to join the Analytical Development team at Genentech San Diego. This position works with the PTCC team to develop and/or improve cell-based assays for cell product characterization and release. The Analytical Development Scientist participates in laboratory activities to support process development, evaluate and develop new assay methods, and perform product characterization for CAR-T cell products. The individual is also involved in assay optimization and standardization and assay transfer to internal or external QC labs. Under the reasonable supervision, the role includes performing assay development experiments, carefully documenting methods and materials, writing SOPs/reports, and communicating findings. The ideal candidate has a proven track record of innovation, demonstrated skill set and knowledge in process and analytical development, and is excited to take on new challenges in a fast-paced and dynamic environment.

Requirements

BS or MS degree in a relevant scientific discipline with five plus years of relevant experience in a biotech environment (an equivalent combination of education and experience may be considered)
Experience in human T cell biology with demonstrated proficiency in a broad range of cellular immunology techniques, including cell-based assays, immunoassays, and flow cytometry.
Experiences with aseptic cell culture (human primary cells and cell lines) and bio-assay development and/or testing
Ability to follow laboratory procedures with attention to detail, and successfully execute experiments at the bench
Demonstrated ability to maintain detailed lab execution records and perform data analysis
Excellent communication skills, data presentation and interpersonal skills
Basic computer skills in Excel, PowerPoint, and word processing
Attention to detail, initiative, and strong organizational skills
Comfortable in a fast-paced small company environment with reasonable direction and able to adjust workload based upon changing priorities.

Nice To Haves

Two plus years of relevant cell therapy industry experience
Foundation in experimental documentation, basic statistical analysis, and data presentation
Exposure in vitro T cell functional assays (potency, cytotoxicity, ELISA, proliferation, Luminex)
Basic skills in molecular techniques including qPCR or ddPCR and electrophoresis.
Experience with drafting SOP and forms
Develops assays for cell product release and characterization by designing and executing studies via design of experiment (DoE)

Responsibilities

Develops analytical test method procedures in accordance with relevant guidelines from ICH, USP, EP for cell therapy product GMP release testing and characterization.
Supports analytical routine testing, qualification, and validation.
Evaluates reagents and supplies to meet QC standards
Co-authors test methods (SOPs), technical reports, and analytical sampling plans
Documents laboratory procedures and experiments with great attention to detail in laboratory notebooks
Performs assays for process assessment and product characterization
Participates in assay transfers to QC and provides lifecycle support
Summarize and present scientific data to project teams.
Evaluates alternative technologies to create robust and reproducible analytical methods
Sets up, monitors, samples, and analyzes cell culture processes
Works with R&D teams to gain deeper understanding of the analytical methods for characterization of product critical quality attributes