Associate Director, Stability Lead Development & Clinical
Core
Define and execute phase-appropriate stability strategies for mRNA products across development, clinical, and commercial stages to ensure regulatory success and uninterrupted patient supply.
Role type
Associate Director, Stability Lead (mRNA/biologics)
Builds
Scalable mRNA medicine supply chains and regulatory submission packages
Domain
Biopharmaceuticals / mRNA therapeutics / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
stability strategy design, statistical analysis, regulatory submission authoring, risk-based shelf-life assignment, cross-functional matrix leadership, degradation trend identification, change-impact assessment, OOS/OOT investigation leadership, lifecycle management
Preferred skills
biologics/vaccines stability leadership, health authority interaction, CMC team structure operation, advanced analytics/generative AI application, process improvement governance
Technologies
digital tools, advanced analytics, generative AI
Responsibilities
Define stability strategies aligned with program objectives; design and oversee stability protocols for IND/CTA and registration submissions; lead stability data review and statistical trending; identify degradation trends and drive mitigation; author stability sections for regulatory submissions; partner with Analytical, Quality, Regulatory, and Supply teams; lead OOS/OOT investigations and risk assessments; contribute to annual product quality reviews and shelf-life reassessments.
Seniority
Senior, hands-on IC with matrix leadership