Jobs at SAB Biotherapeutics

Leads analytical development for biologics programs from early development through commercialization. Responsibilities include hands-on method development, optimization, qualification, validation, transfer, lifecycle management, troubleshooting, investigations, stability and reference standard programs, and regulatory submission support. Ensures cGMP, data integrity, ICH, USP, and regulatory compliance while supporting CMC milestones, laboratory operations, equipment qualification, LIMS implementation, external partners, and inspection readiness.

Leads analytical development and quality control strategy for biologics from early development through commercialization. Oversees method development, validation, transfer, lifecycle management, troubleshooting, investigations, reference standards, critical reagents, comparability, and regulatory CMC submissions. Provides hands-on laboratory leadership, manages internal teams and external partners, ensures cGMP and regulatory compliance, supports inspection readiness, and scales analytical capabilities, equipment, workflows, and LIMS infrastructure.

Leads SAB’s Program Management function and serves as senior program leader for SAB-142 through late-stage biologics development, BLA submission, regulatory review, approval, and launch readiness. Oversees cross-functional execution across clinical, regulatory, CMC, manufacturing, quality, supply chain, finance, and commercial teams. Establishes governance, integrated plans, budgets, risk mitigation, and executive reporting while managing external partners. Builds and develops the Program Management organization and supports commercial readiness, strategic partnerships, and alliance activities.

Leads analytical development for biologics bioassays and potency assays across development, validation, transfer, commercialization, and regulatory submission. Performs method development, troubleshooting, qualification, validation, investigations, CAPA, change control, lifecycle management, and documentation. Supports reagent qualification, stability studies, specifications, GMP compliance, inspection readiness, laboratory operations, equipment maintenance, and LIMS implementation. Collaborates with Quality, external laboratories, and cross-functional teams while ensuring alignment with cGMP, ICH, USP, global regulations, and QbD principles.

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 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.