Position Summary
We are seeking an experienced and motivated Associate 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 Associate Scientist participates in laboratory
activities to support process development, evaluate and develop new assay methods, and perform product
characterization for CAR-T cell products. He/she 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, writingSOPs/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.
Responsibilities
These may include but are not limited to:
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
Requirements, Knowledge, Skills and Abilities
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.
Preferred Qualifications
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)
Thanks
Divya
Never miss an opportunity! Create an alert based on the job you applied for.
