BioAgilytix
  • Operations
  • Durham, NC, USA
  • Full Time

Essential Responsibilities

  • 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
  • Responsible for prompt identification and notification of deviations
  • Perform assays according to GLP guidelines
  • Follow GLP guidelines for validation of assays
  • Run assays independently
  • Set up studies in LIMS system
  • Prepare worksheets independently
  • Analyze & interpret data
  • Prepare summary tables
  • Peer review raw data
  • Prepare buffers
  • Troubleshoot assays
  • Design assay runs independently
  • 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
  • May serve as Principal Investigator 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 (e.g. BAL University)
  • Other duties as needed

Minimum Acceptable Qualifications

Education/Experience: The education and experience requirements for a Scientist I, II, and III are as follows:
  • Scientist I: 
    • Bachelor's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with > 6 years' experience in a scientific laboratory environment; or
    • Master's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with > 4 years' experience in a scientific laboratory environment; or
    • PhD in molecular biology, biochemistry, immunology, biotechnology, or related field > 2 years' experience in a scientific laboratory environment.
  • Scientist II:
    • Bachelor's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with > 8 years' experience in a scientific laboratory environment; or
    • Master's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with > 6 years' experience in a scientific laboratory environment; or
    • PhD in molecular biology, biochemistry, immunology, biotechnology, or related field > 4 years' experience in a scientific laboratory environment.
  • Scientist III:
    • 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.


Skills:

  • Ability to develop immunoassays in some or all of the following immunoassay platforms: ELISA, MSD-ECL, RIA, DELFIA, HTRF, and AlphaScreen
  • Must work effectively within team to meet objectives under time constraints
  • Ability to take direction well and multi-task
  • Detail oriented and highly organized
  • Excellent oral and written communication skills
  • Proficient in the use of MS Excel and Word
  • Demonstrated experience serving in a supervisor role and leading teams
  • Knowledge and application of regulatory guidance to experimental planning and design
  • Experience working in GxP environments and demonstrated knowledge of GxP regulations
  • IA role: Experience with execution of PK/biomarker/ADA assays
  • CB role: Experience with execution of potency/NAb assays

 

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