Responsibilities:

• Run assays independently
• Prepare worksheets independently
• Analyze & interpret data
• Prepare summary tables
• Peer review raw data
• Prepare buffers
• Troubleshoot assays
• Design assay runs independently
• Responsible for prompt identification and notification of deviations
• Write SOPs
• Write plans/reports for sample analysis
• Order and keep accurate inventories of supplies for laboratory needs and forecast future needs based on projected project needs
• Perform assays according to GLP guidelines
• Follow GLP guidelines for validation of assays
• Set up studies in LIMS system
• Serve as lead scientist on assay dev project
• Serve as lead scientist on validation
• Present data to clients
• Independently write plans and reports for validation
• Serve as BPM on a project
• May prepare and submit deviations
• Manage project timelines/scheduling
• Manage budget and revenue for projects
• Communicate with client
• Train analysts/junior scientists
• Develop assay independently
• Ability to assist with definition of project scope and proposal preparation (SME)
• Prepare and review scientific training materials

Requirements:

• Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with > 12 years’ experience in a scientific laboratory environment; or
• Master’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with > 10 years’ experience in a scientific laboratory environment; or
• PhD in molecular biology, biochemistry, immunology, biotechnology, or related field > 8 years’ experience in a scientific laboratory environment.
• Ability to develop immunoassays in some or all of the following immunoassay platforms: ELISA, MSD-ECL, RIA, DELFIA, HTRF, and AlphaScreen
• Experience working in GxP environments and demonstrated knowledge of GxP regulations
• Proficient in the use of MS Excel and Word
• Knowledge and application of regulatory guidance to experimental planning and design