Jade Biosciences, Inc.

United States
55 Total Employees

Jobs at Jade Biosciences, Inc.

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20 Days AgoSaved
In-Office
4 Locations
Healthtech • Biotech • Pharmaceutical
Lead GMP Quality Assurance activities for outsourced manufacturing and supply operations across clinical and commercial stages. Oversee CDMOs, review and approve quality records, manage quality agreements, drive risk management, support regulatory submissions and inspections, and coordinate cross-functional QA documentation, batch release, and issue resolution to ensure compliance with cGMP and regulatory requirements.
Healthtech • Biotech • Pharmaceutical
Lead global CMC regulatory strategy and operations for biologics and combination products. Prepare/manage IND/CTA/BLA/MAA and post-approval submissions, support health authority interactions, advise on manufacturing, analytics, specifications, stability, comparability, and lifecycle changes while collaborating with cross-functional and external partners.