Position performs immunogenicity or clinical chemistry testing in a reference laboratory that provides testing support to clinical trials. Testing methods utilized are complex, problematic and produced in high volume. The procedural steps are performed
by a team in a fast paced environment and documented using GLP practices. Results are reported through an LIS designed for clinical trials. Excellent multi-tasking skills are required to cope with the execution of multiple test methods simultaneously.
Prefer minimum of two years research or clinical laboratory experience with biochemistry techniques; extensive ELISA experience: two years experience with high volume testing with emphasis on autochemistry analyzers. * Experience with troubleshooting and
editing multipoint nonlinear calibration curves. Excellent pipeting technique under high volume conditions is essential. * Experience with assays optimization and validation is desired. * Familiar with Microsoft Office products, Excel and Word. * Possess
good communication and writing skills and able to work effectively in a team when performing assays. * Must be detail oriented, well organized and committed to mastering rigorous documentation standards related to GLP standards and pharmaceutical
clinical trials. * Must have excellent multitasking skills due to the complexity and variety of projects ongoing in each department.
The successful candidate will participate in the transfer of newly developed products from the Life Science Group Reagents R&D team to Manufacturing. Product transfer consists of a variable mix of lab work and computer work. Typical activities include
the development and documentation of production procedures and quality control test procedures, as well as the subsequent training of Manufacturing personnel. Additional responsibilities include material setup in Bio-Rad's ERP system. To a lesser extent,
other activities include supporting the Reagents R&D team in the development of new reagents products and providing post-launch technical support to Manufacturing.
Bachelor’s Degree in Chemistry, Biology, or other related field. The candidate must have a minimum of 3 years of relevant work experience combined with a solid understanding of common molecular biology and biochemistry concepts and techniques.
Additionally, the candidate should have a general understanding of R&D and Manufacturing practices and should be familiar with production procedures and quality control procedures. Experience with PCR / qPCR, cDNA synthesis, bead-based multiplexed
immunoassays, and laboratory automation systems is preferred. Familiarity with product transfer, formulation development, SAP, and DOE / DFSS / LSS is a plus. This position requires the ability to develop and document procedures for diverse laboratory
techniques. Good writing, laboratory, and computer skills are mandatory, as is the ability to quickly learn new skills and apply them in diverse situations. The candidate must be familiar with Microsoft Word and PowerPoint and must have more extensive
experience with Excel (e.g. working with formulas, using lookup tables, etc). The candidate must possess good organizational skills and able to work independently. The candidate must be reliable and attentive to detail. The candidate must have good
communication skills and must be able work effectively within a cross-functional team.