Senior Scientist, Analytical Lead
Core
Leading GMP stability operations and coordinating analytical project delivery for medicines in development from small molecule new chemical entities to clinical-stage investigational products.
Role type
Senior Scientist, Analytical Lead (GMP Stability & Project Coordination)
Builds
Stability samples, validated analytical methods, and inspection-ready documentation for drug development programs.
Domain
Pharmaceutical development / Analytical Chemistry / GMP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP stability operations leadership, cGMP compliance, analytical method validation, HPLC, KF, dissolution, project coordination, team coaching, audit readiness, risk management
Preferred skills
Experience with API, drug product intermediates, and oral solid dosage forms, technology transfer coordination, cross-functional stakeholder management
Technologies
HPLC, KF, dissolution equipment, stability testing systems
Responsibilities
Plan and execute stability sample operations ensuring cGMP standards; coordinate analytical activities across multiple deliverables including method validation; coach and guide scientific staff to build consistent ways of working; maintain inspection readiness through risk management and compliance; identify and implement improvements in stability operations and analytical delivery.
Seniority
Senior, hands-on IC with leadership responsibilities
