| Job Description | Job description:
• Responsible for the development of new or improved IHC diagnostic reagents, including protocol design, assay optimization, assay validation, and assay transfer
• Provide technical support and information for existing IHC CDx assays
• Create technical documentation including protocols, work instructions, SOPs, and technical reports
• Work closely with project manager, perform project management function including project planning, scheduling of tasks, and communicating project status to management
• Collaborate with Seattle Genetics’ Research and Experimental Medicine departments to develop specific CDx assays for pipeline compounds
• Collaborate with Seattle Genetics’ Research department to assess new and emerging technologies that could have future CDx applications
Job Requirements
Education, training, experience:
• Master or PhD degree in a relevant scientific area with at least 3 years (Masters) or 1 year (PhD) of experience in industry
• Technical experience in IHC, PCR, RT-PCR, Mass Spec, and other analytical methods, preferably in a diagnostic product development setting
• Knowledge of and experience in quality and regulatory requirements under which molecular diagnostic products are developed, commercialized and supported (for example 510k or PMA applications, GLP, GCP, and GMP, etc.)
• Knowledge of FDA and CLIA regulations
• Technically proficient, strong scientific creativity, strong problem solving skills and collaboration with other departments
• Experience and understanding of hematology-oncology drug development
• Excellent communication skills; able to evaluate and articulate complex scientific and business issues and implement solutions |
| | Company | | Seattle Genetics | Job Code | | State or Province | | Washington | | |
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