Sr. Manager, CMC Stability
Core
Execute phase-appropriate stability strategies for mRNA programs across development, clinical, and commercial stages to ensure robust product control and uninterrupted patient supply.
Role type
Sr. Manager, CMC Stability (Individual Contributor)
Builds
mRNA medicines and biologics
Domain
Biopharma / mRNA therapeutics
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, shelf-life assessment, OOS/OOT investigation, cross-functional collaboration, data integrity management
Preferred skills
biologics/vaccines stability experience, ICH guidance familiarity, lifecycle management, risk assessment, change evaluation
Technologies
digital tools, advanced analytics, generative AI
Responsibilities
Define and execute stability strategies for assigned programs; Design stability protocols and study plans; Review and interpret stability data and perform trending analyses; Generate recommendations for shelf-life and storage conditions; Support stability input into formulation and control strategy; Author stability sections for regulatory submissions; Partner with cross-functional teams to manage milestones and inventory risk; Lead investigations for stability-related events; Maintain data integrity and inspection readiness; Identify opportunities to improve stability processes.
Seniority
Senior, hands-on IC
