Senior Research Associate, Analytical DevelopmentUnited States - California - Santa MonicaProcess/Product Development & OperationsRegular
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.
- 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
- 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