The primary focus of the Sr. Scientist role is to lead the Residuals Team by designing the phase-appropriate strategy and implementing the plan on Juno’s early and late stage projects. The role is multi-faceted. As a manager, you will mentor the development of the Senior Research Associates, and as an individual contributor, you will design, develop and qualify analytical methods that measure residual process and product-related impurities in the process and final drug product. The Sr. Scientist will work under the guidance of the Associate Director of Analytical Development. This position will require cross-functional engagement with individuals in the Raw Materials Team, Process Development, Toxicology and Biochemical Assay Team.
The key deliverables for this role are:
Strategy and roadmap for process- and product-related impurities of a cell therapy product.
Interact with process development and toxicology to perform risk-assessment for each clinical product
Development and qualification of analytical methods to measure either a small molecule, protein or cell residual.
Method development and qualification reports.
Analytical data packages for Characterization of Impurities section.
Develop, evaluate robustness and qualify analytical methods to measure key residual components.
Provide weekly updates on progress to supervisor.
Manage and mentor a Senior Research Associate, including career development and goal setting.
Represent the needs of the group to the Process Teams.
Experienced with analytical method development using chromatographic separations and multiple detection formats and/or flow cytometry and/or Immunoassays.
Ability to work in a high paced team environment, meet deadlines, and prioritize work.
4+ year experience with adhering to USP, FDA and EMEA impurity guidance.
Ph.D. or equivalent with a minimum of 6 years of experience inclusive of post doc.
Our headquarters, situated in the bustling South Lake Union district of Seattle, sits among some of the most visible organizations in the world. Seattle offers award-winning restaurants, a vibrant, hip music scene and spectacular views of water and mountains. Within an hour’s drive of Seattle, you can be fishing, skiing, hiking or tasting world-class Washington wines.
THINK BIG. BE BRAVE. DELIVER.
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