Vice President Manufacturing

The VP Manufacturing will provide strategic, operational, and technical leadership for the company’s manufacturing activities supporting late-stage clinical development, commercial readiness, and future commercial supply of the company’s lead biologic programs, including SAB‑142.

This role is responsible for establishing scalable, compliant, and cost-effective manufacturing capabilities as the company advances SAB‑142 and other pipeline programs toward commercialization. The company is advancing a novel platform for the production of fully human, multi-targeted immunoglobulins (IgGs).

The VP will lead manufacturing strategy and execution from late-stage clinical production through commercial launch readiness, with responsibility for manufacturing network strategy, CDMO management, technology transfer, scale‑up, process validation, operational readiness, and reliable commercial supply. Experience with biologics manufacturing is required, and expertise in plasma fractionation, plasma‑derived therapeutics, or analogous large‑scale protein purification operations is desired.

Working closely with Quality, Regulatory Affairs, Process Development, Clinical Operations, and Supply Chain, the VP will ensure that manufacturing operations meet global regulatory expectations, support clinical and commercial demand, and maintain a strong culture of safety, quality, compliance, and continuous improvement.

• Develop and execute the overall manufacturing strategy supporting late‑stage clinical development, regulatory approval, and commercial launch readiness.
• Establish scalable manufacturing capabilities through an appropriate mix of internal capabilities and external CDMO partnerships.
• Lead manufacturing network planning, capacity planning, campaign readiness, and long‑term supply resilience.
• Ensure manufacturing strategies support the unique requirements of complex immunoglobulin‑based biologics, and high‑purity protein products.
• Apply knowledge of large‑scale biologics manufacturing; expertise in plasma fractionation or plasma‑derived protein manufacturing is desired.
• Align manufacturing plans with regulatory, clinical, quality, supply chain, and corporate development timelines.

• Provide executive leadership and oversight of CDMO partners supporting bulk process intermediates, drug product, and related manufacturing activities.
• Serve as the accountable manufacturing leader for partner performance, quality, timelines, cost management, and issue escalation.
• Oversee manufacturing campaign planning, batch execution readiness, deviation response, change implementation, and manufacturing performance metrics.
• Partner closely with Quality to ensure effective GMP oversight, vendor quality management, batch disposition support, and inspection readiness.
• Drive operational excellence, continuous improvement, and risk mitigation across the manufacturing network.

• Lead technology transfer of manufacturing processes to external partners and support scale‑up from development through commercial production.
• Oversee process characterization, process performance qualification (PPQ), continued process verification, and commercial process validation activities.
• Ensure successful execution of cGMP manufacturing campaigns supporting clinical supply, registration batches, and future commercial supply.
• Provide technical leadership for investigation and resolution of manufacturing deviations, scale‑up challenges, process variability, and process improvements.
• Leverage expertise in purification, separation, viral clearance, fill‑finish, and related biologics manufacturing unit operations.
• Establish scalable manufacturing capabilities through an appropriate mix of internal capabilities and external CDMO partnerships.
• Lead manufacturing network planning, capacity planning, campaign readiness, and long‑term supply resilience.
• Ensure manufacturing strategies support the unique requirements of complex immunoglobulin‑based biologics, and high‑purity protein…