Senior Manager, Quality Control

Role: Sr. Manager, Quality Control overseeing GMP testing and stability programs for Stoke's RNA-based therapeutic products, including analytical method validation, transfer, and regulatory compliance. Responsibilities: manage GMP release testing at CTLs/CMOs, develop and review analytical SOPs, oversee method validation and transfer, evaluate stability data, support regulatory submissions, and facilitate inspections. Qualifications: B.S. in a scientific field with 8+ years in biopharmaceutical Analytical Development, including 3+ years in device analytical methods (e.g., pre-filled syringes), GMP expertise, and experience supporting regulatory filings. Preferred: M.S./Ph.D., advanced GMP laboratory management skills, and hands-on experience with analytical methods for biologics or drug-device combination products. High-Value: Focus on biologics and RNA therapeutics, stability and release testing for clinical-stage products, regulatory interactions (FDA, EMA), and working within a GxP environment. Cross-functional collaboration with CMC, Regulatory, and manufacturing teams. Location: Hybrid in Bedford, MA, with ~15% travel.