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.
Duties and Responsibilities (include but are not limited to):Manufacturing Strategy and Commercial Readiness
- 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.
Manufacturing Operations and CDMO Management
- 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.
Technical Transfer, Scale-Up, and Process Validation
- 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 products.
Regulatory and CMC Documentation
- Provide strategic leadership for CMC content supporting global regulatory submissions (INDs, BLAs, MAAs, and amendments).
- Author, review, and approve CMC sections of regulatory filings and associated documentation.
- Ensure development of appropriate specifications, control strategies, and stability programs supporting regulatory approval and commercialization.
- Lead manufacturing preparedness activities supporting pre-approval inspections (PAI), regulatory inspections, and commercial licensure.
- Ensure manufacturing systems, documentation, and partner operations remain inspection-ready.
Drug Supply and Supply Chain
- Oversee drug product supply planning and distribution for global clinical programs.
- Partner with Supply Chain leadership to establish integrated supply planning processes, inventory strategies, and long-range capacity planning supporting commercial launch and growth.
- Develop long‑term manufacturing and supply strategies supporting commercial launch readiness and post-launch growth.
Leadership and Organizational Development
- Build and lead a high‑performing Technical Operations / CMC organization.
- Mentor and develop team members across process development, manufacturing, and technical operations.
- Establish strong cross‑functional partnerships across Quality, Regulatory Affairs, Clinical Operations, and Program Management.
Financial and Operational Management
- Develop and manage the Technical Operations budget, including CDMO manufacturing costs.
- Support contract negotiations with manufacturing partners and other key vendors.
- Identify operational risks and implement mitigation strategies to maintain program timelines and regulatory milestones.
Supervisory Responsibilities:This position has supervisory responsibilities.
Education/Experience/Skills:- Ph.D. in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related discipline preferred. Advanced scientific degree strongly preferred.
- 15+ years of progressive experience in biologics manufacturing, technical operations, CMC, or pharmaceutical operations, including significant senior leadership experience.
- Significant experience leading GMP manufacturing operations and managing outsourced biologics manufacturing through CDMOs.
- Demonstrated success supporting late‑stage clinical programs, transitioning biologic products through licensure, and managing commercial manufacturing supply.
- Experience leading technology transfer, process validation (including PPQ), scale-up, and commercial readiness for immunoglobulin-based, or protein-based products.
- Expertise in plasma fractionation, plasma-derived therapeutics, high-purity protein purification, or analogous large-scale separation and purification processes is desired.
- Proven track record contributing to global regulatory filings and CMC documentation.
- Experience supporting BLA submissions, pre-approval inspections, regulatory inspections, and commercial launch readiness activities strongly preferred.
- Experience working within FDA, EMA, MHRA, and other global regulatory frameworks.
- Proven ability to lead cross‑functional initiatives and influence senior stakeholders.
- Strong experience building and leading high‑performing technical teams and collaboratively leading cross-functional initiatives.
- Excellent communication skills with the ability to translate complex technical concepts to executive leadership.
- Strong project management and organizational leadership capabilities. Excellent written and verbal communication skills. Must be proficient in Microsoft Office software (Word, Excel, PowerPoint, and Outlook).
Physical Demands
While performing the duties of this job, the employee is regularly required to walk, stand, and sit. The employee must be able to regularly lift up to 10 pounds. Specific vision abilities required by this individual include close vision, peripheral vision, and the ability to adjust focus. The employee will view a computer monitor for extended periods of time. Job requires good physical mobility. Must be able to periodically enter manufacturing areas and wear appropriate gowning or personal protective equipment as required.
Working Environment and Travel:
- Duties will typically be performed in a home office environment, office environment and manufacturing environment, based on business needs.
- Ability to travel on a regular basis both domestically and internationally to CDMO partners, company locations, and manufacturing sites as required by business needs.
- Experience working in late-stage, pre-commercial, or commercial biotechnology or plasma-derived therapeutics organizations is highly preferred.
ADA
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
This job description will be reviewed periodically as duties and responsibilities change with business necessity. Primary and additional duties and responsibilities are subject to modification.
SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets