Scientist II Bioanalytical Assay Manager

Description
A Bioanalytical Assay Manager is a highly motivated and collaborative individual who participates in the evaluation of validation/qualification reports as well as oversight of assay transfer, feasibility, lifecycle management of immunoassays and mass spectrometry assays to measure biomarkers at Contract Research Organization (CRO) in support of pre-clinical and clinical studies. This individual will work across the organization to help harmonize CRO, platform and assay selection and use. This job does not involve hands-on work in the laboratory. Responsibilities:

• Review of validation/qualification documents and bioanalytical reports
• Assist with the transfer of reagents and method documentation, assay transfer and sample analysis plans, from feasibility to validation/qualification
• Assist with the experimental design and protocol language, evaluate project team data to ensure integrity from a technical perspective and troubleshoot technical problems at the CROs, review CRO technical reports, and may present at BAS working groups
• Support and provide oversight of assay life cycle management at CROs, which will require critical reagent forecasting, requesting of new reagent preparation [within and external to Bioanalytical Sciences Department (BAS)] and shipment to the CRO, review of reagent incorporation/troubleshooting, reagent re-test date extension.
• May be required to attend and participate in technical teleconference with CROs and internal BAS bioanalytical and safety biomarker working groups
• Register and maintain assays in internal database systems and webpages

Requirements:

• B.S. in Biological Sciences or equivalent with a 3 to 5 years hands-on laboratory experience in developing/qualifying quantitative ligand binding methods.
• Familiarity with biochemistry, cellular and molecular biology methods, new analytical technologies, Project management software would be an important advantage. Practical knowledge and understanding of computerized data handling are essential.
• Expected on-campus average of 3-days a week with some flexibility.
• Excellent communication (email, phone, teleconference), interpersonal, and organizational skills are essential. This individual must be a good team player able to work in a fast-paced and highly collaborative environment and be able to work independently as well as on a team. They should be able to multi-task and prioritize work well, and to consistently demonstrate initiative and creativity.

Pay Rate Range: $65-85/hr depending on experience