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.