Senior Research Associate - Analytical/QC

Job Summary

The Analytical Methods Development and Quality Control senior research assoicate will perform laboratory-based activities to design, develop and qualify analytical methods for the characterization, and release testing of the Company’s genome editing, and cell therapy products. Ideal candidate will be experienced, hands-on individual and can independently perform analytical methods development especially the cell-based and molecular bioassays.

The successful candidate will participate develop phase appropriate strategies for analytical method development and will be responsible for execution of the method development, optimization, qualification and validation. He/she will participate cross-functional project team and represent AMD function and perform tech/methods transfer to in-house QC department as well as contract manufacturing organization (CMO).

 

Essential Functions

  • Perform cell-based assays using a variety of readout technologies
  • Perform development activities relating to the optimization and validation of immunoassays
  • Perform analytical testing supporting process development product release, including qPCR, ELISA, flow cytometry
  • Present results in cross-functional meetings
  • Execute and troubleshoot standard protocols, develop and adapt new protocols into practice
  • Maintain a detailed and well-organized laboratory notebook and experiment records.

 

Education, Experience And Skills Requirements

  • Master’s degree with biochemistry, molecular biology, cell biology or related field.  Bachelor’s degree with minimum of 2 years of experience in the pharmaceutical or biotechnology industry will be considered
  • Basic understanding of Immunology is required
  • Experience in immune-bioassay/potency assays using appropriate platform technologies, such as cell culture, ELISA, enzymatic assays experience is required
  • Experience with FACS, cell-based assays and immunoassay is desired
  • Experience with quantitative analytical techniques including qPCR, ddPCR, ELISA, fluorescence-based enzymatic assays is a plus
  • Sound understanding of statistical methods/tools for data analysis
  • Excellent organizational skills, attention to detail and the ability to work independently and within a multi-disciplinary environment
  • Excellent written and oral communication skills