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Scientist II
Updated on 1/25/2023
Locations
Seattle, WA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Requirements
  • PhD in Molecular Biology, Biochemistry, Biomedical engineering or related field with 2+ years' experience in relevant industry setting; or MS degree with 6+ years' experience in relevant industry setting; or BS with 8+ years' experience in relevant industry setting
  • Solid understanding of multiplex PCR and NGS technologies
  • Experience executing formal verification and validation testing
  • Exceptional scientific technical writing, communication, and organizational skills, with a significant attention to detail. Must be able to communicate effectively, both written and verbally with technical and non-technical audiences
  • Ability to manage ambiguity and achieve progress while building consensus
  • Demonstrated ability to think strategically when planning and managing responsibilities
  • Must work independently and be able to prioritize and manage multiple projects
  • Experience working within a Product Development Process (PDP) for regulated diagnostic products (LDT/CLIA, FDA IVD, CE-IVD, GCP Clinical Trial Assays)
  • Experience with JMP, R, or other statistical analysis software
  • Experience with CLIA/CAP laboratory
Responsibilities
  • Responsible for development and validation of regulated products within a matrixed core-team environment for Adaptive's Immune Medicine business. Focus will be on new GCP-compliant Clinical Trial Assays and investigational use products that serve as precursors to future T-Detect diagnostic panels, and drive pharma partnerships utilizing T-cell measurements as endpoints in clinical trials. Occasionally support validation activities related to clonoSEQ single-site IVD and laboratory developed test (LDTs) products for Adaptive's MRD business
  • Independently manage IVD-level verification and validation studies (AV/CV), providing innovative strategies to comply with appropriate regulatory guidance and standards, including FDA, ISO, and CLSI. Must deliver results according to study timelines, product development plans, design trace matrices, and other Design Control related requirements
  • Establish sample processing plans, execute applicable sample manipulation and contriving, and coordinate validation study execution with Adaptive's production lab
  • Author technical documents (protocols/reports), contribute to document review, and compile/reference supplementary documents for data packages/submissions
  • Participate in cross-functional core teams with the R&D, Biostats, CompBio, Clinical Ops., RA/QA, Laboratory Ops., Commercial, and Bus Dev. groups to ensure project/product success. Engage deeply to understand requirements from different functional areas, propose solutions, and facilitate issue resolution
  • Become a subject matter expert on Adaptive's products. Provide scientific guidance and technical expertise
  • Ensure compliance with internal procedures, design control, FDA and CLSI guidelines and other applicable standards and regulations
Desired Qualifications
  • Equity grant
  • eligible
Adaptive Biotechnologies

501-1,000 employees

Immune-driven medicine biotech company