Remote with required flexibility to travel as needed.
Drug substance process design
Clinical and commercial readiness
External cro/cdmo management
Praxis Precision Medicines is seeking a Director of Process Chemistry to lead drug substance activities for small molecule and ASO programs, focusing on clinical and commercial readiness. The ideal candidate will have extensive experience in CMC for small molecules and a strong understanding of regulatory requirements, with an emphasis on innovation and collaboration in a fast-paced environment
Job Summary
As Director of Process Chemistry, you will take the lead on drug substance activities for one or more projects within Praxis’ portfolio of small molecule and ASO programs to drive forward both clinical and commercial readiness.
You will design products & processes that support clinical phase testing and then mature those processes through development to Commercial supply.
At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.
Matching Summary
Match Score: 85
Praxis Precision Medicines is seeking a Director of Process Chemistry to lead drug substance activities for small molecule and ASO programs, focusing on clinical and commercial readiness. The ideal candidate will have extensive experience in CMC for small molecules and a strong understanding of regulatory requirements, with an emphasis on innovation and collaboration in a fast-paced environment.
Skills & Requirements
Must-have
drug substance process design
clinical and commercial readiness
external CRO/CDMO management
cGMP requirements and best practices
CMC development across all phases
Nice-to-have
continuous processing
biocatalysis
catalysis
high throughput experimentation
entrepreneurial spirit
Key Requirements
Minimum of 12 years industry experience
Advanced degree in Chemistry or related discipline
Experience with salt/crystalline form selection preferred
Experience with oligonucleotide chemistry is a plus