Nexelis is an immunology-centric CRO specialized in clinical assay development in single and multiplex formats and sample analysis for low-, mid- and large-scale clinical testing. Our versatile team of scientists and technology platforms have been instrumental in the development, qualification and validation of assays supporting FDA filings of over 100 new molecular entities, including blockbuster biologics such as vaccines and complex large molecules.
- Our Seattle office focuses on Bioanalytical Services (PK, Immunogenicity ADA Assays, & Fit-for-Purpose Biomarkers), in addition to offering an extensive Biomarker Menu.
- We are seeking a highly motivated Senior Scientist with experience in bioanalytical immunoassays. The position requires excellent ability to develop and validate bioanalytical immunoassay methods, design research methods and testing procedures on a variety of different platforms, troubleshoot assay performance problems, and draft validation reports with minimal supervision and guidance.
- If you are interested in working in a dynamic biotechnology environment that is challenging, rewarding and a source of personal pride and growth, we’re interested in hearing from you! Nexelis is located in Seattle, surrounded by mountains, forests and waterways of the Pacific Northwest.
- Develops and validates bioanalytical immunoassay methods, design research methods and testing procedures on a variety of different platforms, troubleshoot assay performance problems;
- Organizes and documents scientific projects and activities. Monitors new assay validation/development progress and client assay validation reports and communications;
- Writes and reviews assay methods, validation plans, validation and qualification reports, assay checklists, and SOPs;
- Reviews validation and clinical testing data and ensures timely reporting of test results;
- Manage and monitor critical reagent/QC inventory and expiration and ensure timely transition of new reagents;
- Coordinates with internal and external customers to integrate services and data into new and ongoing tests;
- Relays information in a timely manner to supervisory personnel regarding problems that may impact the laboratory’s ability to meet expected service and turn-around-time;
- Performs other duties related to laboratory performance and efficiency as assigned to support the overall objective of the position.
Experience and Qualifications
- At least 4 years of bench laboratory experience in a clinical or GLP laboratory.
- Experience with biomarkers, pharmacokinetic and/or anti-drug antibody (immunogenicity) assays is required;
- Understanding Good Laboratory Practice and how it is applied to above services is required;
- The position requires good knowledge of theories and principles of biology/immunology and protein chemistry techniques, such as but not limited to, immunoassays for bioanalytical immunogenicity and pharmacokinetic testing for large molecules;
- Requires well-developed skills using office productivity applications such as spreadsheets, data reduction and statistical applications, and presentation graphics;
- Requires well-developed human relations skills to understand scientific concepts and/or consult with senior colleagues for purposes of problem solving;
- Requires the ability to analyze and solve technical problems under time pressure; Requires the ability to read, interpret and apply complex technical information;
- Must be detail oriented, well organized and committed to mastering rigorous documentation standards related to GLP and GCP standards.
Bachelor's or Master's degree in biology/immunology or related field.