SciPro has recently partnered with a globally renowned pharmaceutical company’s small molecule startup team on a Process Development Principal Scientist (AD level) search. This small molecule team is currently supporting rapid pipeline development with a vision to revolutionize the treatment options for individuals with rare diseases. This team offers all the benefits of a startup's team culture while also providing strong backing as a highly-ranked large pharma company. The company is looking to bring on a OSD Formulator to contribute the continued growth of their small molecule programs.
Advanced degree in Pharmaceutical Sciences/Chemical Engineering, or other relevant life sciences concentration with 6+ years of industry experience
Technical expertise in oral solid dosage product formulation development
Highly experienced in cGMP & pharmaceutical regulatory guidelines
Technical understanding of modeling and simulation related to product development
Experience with amorphous and/or spray dry dispersions
Experience authoring CMC modules of NDA/MAA submissions
Process Development experience for small molecules, oligonucleotides, and/or peptides
Late-stage manufacturing experience (process validation and optimization) is a major plus!
What you’ll be doing:
Contributing to the OSD Drug Product team in executing all development goals and operations
Supporting drug product formulation operations for company programs (small molecules and oligonucleotides)
Working cross-functionally with DS/QC/QA/AD teams to troubleshoot product development criteria and support CMC program development
Ensuring GMP compliance both internally and externally
Contributing to the development of advanced process modeling solutions and control strategies
If this role aligns with your skillset and career goals, please apply below!