Sr. Scientist, Pharmaceutical Development
Core
Senior technical leader in Pharmaceutical Development driving process development, material characterization, and analytical strategies from early discovery through commercialization.
Role type
Senior IC pharmaceutical development scientist (CMC)
Builds
Robust, phase-appropriate formulations and manufacturing processes for neurological, psychiatric, endocrine, and immunological drug products
Domain
Biopharmaceuticals / Pharmaceutical Development / CMC
Required skills
cGMP compliance, process design and optimization, scale-up and validation, technology transfer, analytical method development and validation, stability program management, regulatory submission authorship (IND/NDA/MAA), CRO/CDMO management, Quality by Design (QbD), statistical analysis (DoE), root cause analysis, cross-functional leadership
Preferred skills
Postdoc experience, emerging technology implementation, advanced characterization instrumentation expertise, strategic thinking, project management
Technologies
DoE, QbD, cGMP, IND, NDA, MAA, ICH guidelines, FDA, EMA