Associate Principal Scientist Formulation - Oral Solids
Core
Provide expert technical support for commercial pharmaceutical products across global manufacturing sites and contract facilities, ensuring product performance and quality.
Role type
Associate Principal Scientist (Formulation - Oral Solids)
Builds
Drug product control strategies, manufacturability strategies, and product quality risk management activities.
Domain
Pharmaceutical Sciences / Commercial Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Advanced knowledge in pharmaceutics and drug product development, GMP and regulatory compliance, product lifecycle management, technology transfer, control strategies, impurity and risk assessment, problem-solving for manufacturing issues, regulatory documentation authoring, cross-functional collaboration, project management.
Preferred skills
PhD in Chemistry, experience with extractables and leachable assessments, nitrosamines risk assessments, PPQ programs.
Technologies
GMP, data integrity systems, regulatory file management tools.
Responsibilities
Oversee product performance across global manufacturing sites, define and uphold technical standards, evaluate and implement complex technical changes, conduct impurity and risk assessments, provide technical leadership during issue management, support resource and budget planning, author and review regulatory documentation, assist in developing CAPAs.
Seniority
Senior, hands-on IC
