Stability Manager
Core
Manage cGMP stability programs for preclinical and clinical vaccine development projects, ensuring data integrity and regulatory compliance.
Role type
Senior IC stability manager (vaccine/biologics)
Builds
Stability studies, data analysis, and regulatory documentation for vaccine products
Domain
Biopharmaceuticals / Vaccine development
Required skills
cGMP stability program management, stability study design and execution, statistical data analysis (JMP), regulatory guideline knowledge (FDA/ICH/EU), SOP and protocol authoring, shelf-life determination, deviation/CAPA management, technical writing
Preferred skills
IND/NDA/BLA submission experience, CMO collaboration, global regulatory alignment
Technologies
JMP, stability databases, statistical software (via careerplan.io/jobs/4892976008-stability-manager-at-vaxcyte)
Responsibilities
Design and execute stability studies for early and late-stage vaccine products; summarize stability results using statistical analysis; create and manage stability databases and reports; author and approve SOPs, protocols, and regulatory documents; determine expiration dates for clinical materials; manage Quality Systems records including deviations and CAPAs; drive continuous improvement in stability programs.
Seniority
Senior, hands-on IC
