Associate Principal Scientist (Analytical)
Core
Provide expert technical support for analytical sciences to commercial pharmaceutical products manufactured internally and externally, ensuring testing methods and control strategies remain fit for purpose.
Role type
Associate Principal Scientist (Analytical)
Builds
Drug product control strategies, analytical methods, and quality risk management activities for commercial supply.
Domain
Pharmaceutical industry, Analytical Sciences, CMC
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical sciences expertise, Control strategy definition, Specification setting, cGMP principles, Risk management, Regulatory compliance, Technical problem-solving, Project portfolio management
Preferred skills
CMC cross-functional experience, Formulation knowledge, Packaging expertise, Automation validation
Technologies
Analytical technologies, Dashboards, Regulatory file systems
Responsibilities
Lead review of analytical methods performance via dashboards, Support analytical lifecycle activities for commercial products, Manage prioritized portfolio of project activities, Lead complex technical improvements including extractables/leachables and impurity risk assessments, Provide training in subject matter expertise, Author regulatory files and support license renewals, Resolve manufacturing/method/formulation issues impacting supply
Seniority
Senior, hands-on IC