Director, CMC Stability
Core
Lead end-to-end stability function for biologics, vaccines, and mRNA therapeutics, translating target product profiles into robust shelf-life strategies and regulatory submissions.
Role type
Director, CMC Stability (Strategy & Execution)
Builds
Stability study designs, regulatory submission packages, portfolio-level forecasting dashboards, and expiry assessments.
Domain
Biopharmaceuticals / mRNA therapeutics / Regulatory CMC
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Stability strategy design, regulatory submission authoring, statistical shelf-life assessment, cross-functional team leadership, risk-based decision making, capacity planning, out-of-trend investigation, ICH Q1A–Q1E guidance knowledge, data trending analysis, governance model establishment
Preferred skills
PhD in Life Sciences/Chemistry/Engineering, biologics/vaccine/mRNA stability expertise, global stability regulatory expectations, executive presence, strategic portfolio prioritization
Technologies
ICH Q1A–Q1E, statistical analysis tools, stability forecasting dashboards
Responsibilities
Lead stability strategy across non-clinical, clinical, and commercial programs; define scientifically robust study designs; oversee regulatory submission authoring; drive capacity utilization and forecasting; lead cross-functional teams; manage out-of-trend investigations and deviations.
Seniority
Director, strategic leadership with hands-on technical judgment
