Jobs at SAB Biotherapeutics

Lead manufacturing strategy and execution for late-stage clinical and commercial biologics supply. Oversee CDMO partnerships, technology transfer, scale-up, process validation, GMP operations, CMC documentation, regulatory readiness, supply planning, and build a high-performing Technical Operations organization.

Execute and validate bioanalytical and ligand-binding immunoassays, perform PK analysis of clinical samples, maintain electronic lab notebooks, ensure GCLP compliance, support regulatory documentation, and manage general laboratory operations.

Lead and scale global Quality Assurance to support transition from late‑stage clinical development to commercialization. Own GxP compliance, quality systems, clinical and CMC quality oversight, supplier and manufacturing quality, inspection readiness, and responses to regulatory observations. Partner cross‑functionally to ensure timely release of clinical materials and regulatory submission readiness while building a high‑performing QA team and driving continuous improvement.

Lead and manage global Phase II/III clinical trials from start-up through close-out. Oversee protocol development, site selection, CRO and vendor management, eTMF/EDC oversight, budget and timeline tracking, risk mitigation, and regulatory/GCP compliance. Coordinate cross-functional teams and communicate study status to stakeholders.

Lead quality systems in a cGMP biotech environment: manage batch record review, deviation investigations, change control, CAPA, regulatory inspection support, mentor junior QA staff, and drive continuous improvement and cross-functional quality projects.

Perform routine immunoassays and cell-based/bioassays, assist with antigen and vaccine/adjuvant preparation, support assay development and qualification, document results and maintain lab notebooks, help write SOPs/ROPs, and perform general lab maintenance and reagent preparation.

Lead regulatory strategy and submissions (INDs, BLAs, MAAs, NDAs) for biologics, manage RA team, ensure GMP/ICH compliance, coordinate cross-functionally, handle inspections/audits, and oversee regulatory reporting and labeling throughout product lifecycle.

Manage and continuously improve the Quality Management System (QMS) in a biotech GMP environment. Support implementation, validation, and lifecycle management of GxP computerized systems (eQMS, LIMS, etc.), ensure compliance with 21 CFR Part 11/Annex 11 and ALCOA+ data integrity, drive document control, change control, deviations, CAPA, and promote risk-based quality culture across cross-functional teams.

Develop, implement, and continuously improve GxP training and personnel qualification programs. Manage LMS/eQMS training systems, ensure inspection readiness, create role-based curricula and competency frameworks, link training to quality systems (deviations, CAPA, change control), and drive cross-functional compliance and training effectiveness.