Title: Scientist III, R&D, Biochemistry
Location: West Hills, CA 91304
Duration: 12 Months
Job Description:
Division: Transplant Diagnostics
How will you make an impact?
Working within the Biochemistry group on new product feasibility in antibody detection, development, data analysis, internal and regulatory (i.e., FDA) verification & validation studies, assay technology transfer, training, troubleshooting, and improving the existing antibody detection related products, reagents, and processes.
What will you do?
· Working with other scientists on assay development (solid phase bead platform, Luminex based assays, and point of care/lateral flow assays)
· Identifying and testing the variables of an experiment for troubleshooting and product feasibility
· Using scientific writing techniques to write test plans, executing testing, formatting data, and writing reports – internal and external facing documents.
· Setting up and working with the Luminex, flow cytometer, Biodot dispenser and other related instruments
· Troubleshooting problematic reagents and procedures
· Using process improvement tools to write, modify and improve existing standard operating procedures (SOPs)
· Documenting and collaborating on newly developed protocols and procedures.
· Analyzing data using internal software (Panda, HLA fusion), Microsoft Excel, macros, and other related software
· Communicating data and concepts to a scientific community using Microsoft Excel and PowerPoint
· Maintaining a clean and organized lab area – experience with 5S principles, updating inventory, maintaining equipment, and documenting calibration/maintenance
How will you get here?
Education
At minimum, Bachelor’s degree in the Biology, Biochemistry, Molecular Biology, or Immunology Sciences with 3-5 years industry experience Master’s degree preferred, in Biology, Biochemistry, Molecular Biology, or Immunology Sciences
Experience
3 years of post-graduate or equivalent independent research/industry experience Experience running immunoassays, protein purification, ELISA, Flow Cytometry, Luminex Instruments, multiplex assays, lateral flow assays, and point of care tests.
Experience with submitting products for regulatory clearance (510(k), CE-IVD, etc.) Experience with product and assay development
Knowledge, Skills, Abilities
Knowledge and ability to perform pipetting, molarity calculations, dilution calculations, Microsoft Excel, Word, and PowerPoint.
Must have a positive attitude, good communication skills, reliability, problem-solving skills, integrity and be organized.