Bioanalyst

Role: Bioanalyst responsible for developing and executing bioanalytical assays to support clinical-stage oncology drug development. Objectives include designing, validating, and implementing assays for multiple therapeutic candidates, ensuring regulatory compliance, and managing external CRO relationships. Responsibilities encompass assay development across modalities (small molecules, ADCs), overseeing CRO performance, collaborating with cross-functional teams, and authoring regulatory documentation such as protocols, analysis plans, and submissions. Requirements: minimum 5 years in a regulated bioanalytical setting, with experience in various modalities and managing global CRO vendors; hands-on expertise in method development and validation (ligand-binding, LC-MS/MS); familiarity with GxP, GLP, GCLP, ICH M10 guidelines; strategic understanding of bioanalytical support for clinical and regulatory programs. Preferred qualifications include strong communication skills, ability to lead multiple projects in a fast-paced environment, and experience supporting global regulatory interactions. High-value specifics include support for oncology therapeutics, including ADCs and radioligands, with a focus on clinical development stages and regulatory submissions. The role reports to the Associate Director, Bioanalytical, and is based in Washington State, with no travel specified.