We are seeking a highly motivated Scientist I with experience in bioanalytical immunoassays. The position requires excellent ability to validate and/or develop 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.
- 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
- 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.