Jobs at SAB Biotherapeutics

The Accounting Manager oversees accounting operations, financial close, general ledger, accounts payable, reconciliations, reporting, and internal controls. The role leads ERP implementation and finance systems integration, including configuration, testing, data governance, and post-launch optimization. Responsibilities also include SOX readiness, audit and SEC reporting support, process improvement, policy maintenance under U.S. GAAP, and supervision of accounting staff within a growing biotech organization.

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.

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.

Lead global pharmacovigilance for late‑phase biologics, oversee signal detection and safety reporting, author integrated safety documents for BLA/MAA, manage PV vendors/databases, advise cross‑functional teams, and build PV infrastructure and regulatory filing strategies.

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 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.

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.

Support bench- and clinical-scale protein purification and equipment maintenance in process development and manufacturing. Maintain GLP records and lab notebooks, create and optimize chromatography methods, prepare buffers, track samples, perform cleanroom duties, assist calibrations, environmental monitoring, shipping/receiving, and clinical fill support as needed.