About
We focus on pre-clinical biotech focusing on diseases to prevent uncontrolled neutrophilic inflammation. We are looking for a CMC consultant with microbial and enzyme replacement related experience for IND-enabling studies. Ideally, the consultant should have worked with Pichia and enzyme/R-proteins.
Responsibilities
- Support day-to-day monitoring of our CDMO: review reports, identify gaps, recommend next steps
- Compiling and lead authoring of Module 3 CMC related documents for IND studies
Ideal Candidate
Skills
Functional Areas
CMC
Product Technologies
Recombinant Product
Microbial
Development Phases
Pre-clinical
I/Exploratory
Regulatory Pathways
IND
Qualifications
Education
- PhD (Doctor of Philosophy)
- MS (Master of Science)