Jobs at Keros Therapeutics

Directs regulatory operations for a biotech company, overseeing Veeva Vault RIM administration, health authority archives, submission management, training, reporting, SOPs, and system validation. Provides eCTD/CTD publishing and quality control for major submissions such as INDs and BLAs, coordinates internal regulatory functions and external vendors, and maintains submission templates and regulatory information management processes.

Leads biologics process development across upstream and downstream operations, including CHO cell culture, bioreactor scale-up, process optimization, technology transfer, and cGMP manufacturing support. Manages scientists and engineers, oversees multiple development programs, coordinates cross-functional teams and CDMOs, supports regulatory CMC submissions, and ensures scalable processes, data integrity, process characterization, and validation readiness throughout the biopharmaceutical lifecycle.

Keros invites individuals to join their Talent Community for future opportunities. They focus on diversity and building an inclusive culture.

Lead analytical strategy and method development for protein therapeutics across preclinical to commercial stages. Oversee protein characterization, stability, CDMO/CRO oversight, analytical method validation, cross-functional collaboration, regulatory CMC support, and mentor a team of scientists.

Lead PV science and operations for early-stage and clinical programs: oversee PV vendors and databases, drive signal detection and risk management, author aggregate safety reports and SOPs, ensure inspection and launch readiness, perform QC and document control, and collaborate cross-functionally to support regulatory submissions and pediatric risk strategies.