Vice President Manufacturing

Role Overview

This executive role is responsible for directing manufacturing strategy and operations for the company’s biologics portfolio, with emphasis on late-stage clinical supply, preparation for commercial launch, and long-term commercial supply for lead programs including SAB‑142. The organization is developing a novel platform used to produce fully human, multi-targeted immunoglobulins (IgGs).

The position calls for strategic, operational, and technical leadership to build manufacturing capabilities that are scalable, compliant, and cost-effective as programs move toward commercialization. Strong background in biologics manufacturing is essential, and experience with plasma fractionation, plasma-derived therapeutics, or comparable large-scale protein purification operations is preferred.

You will collaborate closely with Quality, Regulatory Affairs, Process Development, Clinical Operations, and Supply Chain to ensure manufacturing activities satisfy global regulatory expectations, support clinical and commercial demand, and reinforce a culture of safety, compliance, quality, and continuous improvement.

Manufacturing Strategy and Commercial Readiness

• Create and implement the end-to-end manufacturing plan for late-stage development, regulatory approval, and readiness for commercial launch.
• Design a scalable production model using the right combination of internal capabilities and external CDMO partnerships.
• Own manufacturing network planning, capacity planning, campaign readiness, and supply continuity over the long term.
• Shape strategies that address the specialized needs of complex immunoglobulin-based biologics and high-purity protein products.
• Use practical knowledge of large-scale biologics manufacturing; experience in plasma fractionation or plasma-derived protein production is desirable.
• Keep manufacturing plans synchronized with clinical, quality, regulatory, supply chain, and business development timelines.

Manufacturing Operations and CDMO Oversight

• Provide senior leadership for CDMO partners involved in bulk intermediates, drug product, and related manufacturing work.
• Act as the key manufacturing owner for partner performance, quality outcomes, timelines, costs, and escalation of issues.
• Guide campaign planning, batch execution readiness, deviation handling, change implementation, and performance tracking.
• Work with Quality to maintain strong GMP oversight, vendor quality controls, batch disposition support, and inspection preparedness.
• Advance operational excellence, risk reduction, and continuous improvement across the manufacturing network.

Technology Transfer, Scale-Up, and Validation

• Direct technology transfer of processes to external partners and support scale-up from development into commercial operations.
• Oversee process characterization, PPQ, continued process verification, and commercial validation efforts.
• Ensure cGMP campaigns are executed successfully for clinical supply, registration batches, and future commercial supply.
• Provide technical guidance for investigation and resolution of deviations, scale-up issues, process variability, and improvement initiatives.
• Apply expertise in purification, separation, viral clearance, fill-finish, and related biologics manufacturing unit operations.

Regulatory and CMC Documentation

• Lead CMC strategy and content for global regulatory submissions, including INDs, BLAs, MAAs, and amendments.
• Prepare, review, and approve CMC sections of filings and supporting documentation.
• Help define specifications, control strategies, and stability programs needed for approval and commercialization.
• Drive manufacturing readiness for pre-approval inspections, regulatory inspections, and commercial licensure.
• Ensure manufacturing systems, records, and partner operations remain ready for inspection at all times.

Drug Supply and Supply Chain

• Oversee drug product supply planning and distribution for global clinical programs.
• Partner with Supply Chain leadership to build integrated planning, inventory strategy, and long-range capacity planning for launch and growth.
• Develop long-term manufacturing and supply approaches that support launch readiness and post-launch expansion.

Leadership and Organizational Development

• Build and guide a high-performing Technical Operations / CMC team.
• Coach and develop team members across process development, manufacturing, and technical operations.
• Strengthen collaboration across Quality, Regulatory Affairs, Clinical Operations, and Program Management.

Financial and Operational Management

• Develop and manage the Technical Operations budget, including external manufacturing expenses.
• Support negotiations with manufacturing partners and other critical vendors.
• Identify program and operational risks and put mitigation plans in place to protect timelines and regulatory milestones.

Additional Details

This role includes supervisory responsibility. Work may take place in a home office, standard office setting, and manufacturing environment depending on business needs. Regular domestic and international travel is required to visit CDMO partners, company sites, and manufacturing locations.

Physical expectations include regular walking, standing, and sitting; lifting up to 10 pounds; sustained computer use; good mobility; and periodic entry into manufacturing areas with required gowning or personal protective equipment. The employer will provide reasonable accommodations in accordance with the Americans with Disabilities Act.

This job description may be updated as business needs change, and duties may be modified accordingly. The company maintains an equal employment opportunity policy and does not discriminate on the basis of protected characteristics.

Excellent written and verbal communication, strong project management, organizational leadership, and proficiency with Microsoft Word, Excel, PowerPoint, and Outlook are expected.

Education and Experience

A Ph.D. in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related field is preferred, and an advanced scientific degree is strongly preferred. The role calls for 15+ years of progressive experience in biologics manufacturing, technical operations, CMC, or pharmaceutical operations, including substantial senior leadership experience.

Applicants should have significant experience leading GMP manufacturing operations and overseeing outsourced biologics manufacturing through CDMOs. A track record of guiding late-stage clinical programs, moving biologic products through licensure, and managing commercial supply is required.

Experience with technology transfer, PPQ, scale-up, and commercial readiness for immunoglobulin-based or protein-based products is important. Prior involvement in plasma fractionation, plasma-derived therapeutics, high-purity protein purification, or similar large-scale separation and purification operations is preferred.

Experience with global filings and CMC documentation, including BLA submissions, pre-approval inspections, regulatory inspections, and commercial launch preparation, is strongly preferred. Familiarity with FDA, EMA, MHRA, and other international regulatory frameworks is also expected.

The ideal candidate can influence senior stakeholders, lead cross-functional initiatives, and build high-performing technical teams.