Job Duties:

  • Identify and implement analytical development methodologies employed for both Plasmid and Microbiome based platforms.
  • Plan and coordinate analytical development and tech transfer activities in cGMP environment.
  • Implement 21CFR part 211 software
  • Direct and assist in the qualification of analytical methods and stability programs including qPCR, sequencing, MALDI-TOF, ELISA, Electrophoresis, etc, in order to characterize a diverse microbial product portfolio
  • Direct and assist in developing novel methodologies or optimizing existing techniques
  • Analyze and interpret data collected by other team members and create reports and presentations
  • Ensure analytical development deliverables are met in a timely manner
  • Perform process monitoring, data analysis and data presentation in team meetings
  • Perform hands-on analytical development activities related to sequencing, stability indicating assays, release assays and characterization.

 

Requirements:

Must have bachelor’s degree in bioscience, bioprocess, or biomedical engineering or a related field

Must have 6 years of experience working with assay development and validation.  The stated experience must include the following:

  • Developing assays for early/late-stage clinical development and commercial supply
  • Designing key experiments and executing analytical assays
  • Supporting tech transfer to internal Quality Control operations

Alternatively, we will accept a Master’s degree and 4 years of required experience or a PhD and research capability in analytical development science involving bioassays as demonstrated by past research experience or at least 1 scientific publication.