SRAII, Analytical Development

Job Description

Responsibilities (include but not limited to):

• 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.

Basic Qualifications:

• Master’s Degree and 2+ years of industry experience OR
• Bachelor’s Degree and 4+ years of industry experience OR
• Associate Degree and 5+ years of industry experience OR
• High School Degree and 6+ years of industry experience

Preferred Qualifications:

• Experience with Mammalian cell culture
• Experience with molecular biology techniques (transduction, titer, DNA/RNA extractions, cDNA synthesis, PCR, ELISA).
• Analytical method development in one or more of the following:
  • Droplet digital PCR (ddPCR)
  • Realtime quantitative PCR (qPCR)
  • ELISA, MSD, Luminex
  • Viral titer, IFU assays
• Experience with software including GraphPad, SoftMax, JMP, Geneious (or similar), MS Office suite
• Proven ability to work in a fast-paced environment, meet deadlines, & prioritize work on multiple projects.
• Strong attention to detail with the ability to handle multiple responsibilities simultaneously
• Ability to work independently and as part of a team.
• Strong interpersonal skills and communication skills including verbal and written communication are essential in this collaborative work environment
• Occasional travel

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