Sr. Scientist - Small Molecule

Role

Lead analytical development supporting small and large molecule drug development from early clinical to commercialization.

Responsibilities

• design, validate, transfer analytical methods
• oversee stability studies and trending analysis
• collaborate with CROs and CMOs
• prepare regulatory documentation
• represent as analytical lead on CMC teams
• troubleshoot technical challenges
• evaluate data for regulatory submissions
• innovate with new assay technologies

Requirements

• Ph.D. (3+ years) or M.S. (8+ years) in pharmaceutical or analytical sciences
• 3+ years industry experience in analytical development
• strong expertise in chromatographic and spectrometric techniques (HPLC, UPLC, GC, LC-MS, UV/Vis)
• experience with GMP, ICH, FDA standards
• proven method development, validation, transfer, and stability oversight skills

High Value

• small and large molecule modalities
• drug development stages from early clinical to commercialization
• CMC regulatory support
• assay technology innovation
• cross-functional collaboration
• interaction with CROs/CMOs

Work Setup

likely office-based with potential industry-standard travel.