Technical Operations Manager CMC

Role: Technical Operations Manager supporting CMC activities for both commercial and development-stage biopharmaceutical and combination products. Responsibilities: drive process development, validation, tech transfer, analytical and manufacturing support, and lifecycle management; oversee investigations, change controls, deviations, CAPAs, and risk assessments; manage stability programs; author and review technical documentation for regulatory submissions; coordinate with internal teams, CMOs, CTLs, and regulatory bodies; oversee inventory, shipping, and site operations. Requirements: B.S./M.S. in Pharmaceutical Sciences, Chemistry, Biomedical Engineering, or related; 10+ years in pharma/biotech/medical device industries with at least 5 years in CMC development, process validation, analytical sciences, and regulatory submissions; proven experience managing CMOs and cross-functional teams; strong technical writing and project management skills. Preferred: experience with AI-enabled process optimization. High-Value: expertise in combination products, regulatory compliance (FDA, EMA, ICH, ISO), and global lifecycle management; domestic and international travel up to 15%. Work setup: hybrid out of Concord, CA, working twice a week onsite.