Position Summary:

Establish analytical methods to evaluate lentiviral and retroviral vector transduced samples for impurities, GC, IFU and VCN assays.

Perform qualification studies for Analytical methods per established guidance.

Author, review and approve technical documents including standard operating procedures, test methods, and technical reports.

Work with a cross-functional team to develop, adapt, execute, and document analytical methods to characterize the processes for manufacturing lots of drug substance and drug products.

Requirements:

B.S in Molecular biology or related discipline with 2+ years of industry experience.

Background in Gene & Cell Therapy; experience with analytical techniques (transduction, titer, DNA/RNA extractions, cDNA synthesis, PCR, ELISA).

Analytical method development in one or more of the following techniques:

o Droplet digital PCR (ddPCR)/quantitative PCR (qPCR)

o ELISA, MSD, Luminex

o Viral titer assays

o Mammalian cell culture

Experience with software including GraphPad, SoftMax, JMP and/or Geneious, MS Office suite