Senior Expert Science & Technology
Core
Lead scientific leadership and team management for late-phase analytical method validation, optimization, and delivery of drug development programs for pharmaceutical/biological/cell-gene therapies.
Role type
Senior Expert Science & Technology (Management Track)
Builds
Drug substances (DS), drug products (DP), and processes for generic and innovative therapies
Domain
Pharmaceutical/Biotech, Analytical Chemistry, Drug Development
Required skills
Analytical method validation, Chromatography, Dissolution testing, Statistical tools, GMP compliance, Regulatory strategy, Team leadership, Project management, Technical writing, Mass spectrometry
Preferred skills
Data Science, Materials Science, Process Simulation, Technical Writing, Waterfall Model
Technologies
LIMS, Chromeleon, MS Office
Responsibilities
Design, plan, execute, and interpret analytical activities for drug substance and product development; Optimize and validate robust analytical methodologies for oral solid dosage forms; Author analytical documents supporting global project strategies; Mentor and coach scientific associates; Ensure compliance with SOPs, GMP, and quality guidelines.
Seniority
Senior, hands-on IC with management responsibilities
