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 reputed company 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 reputed company 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 reputed company improvement. Duties and Responsibilities (include but are not limited to): Manufacturing Strategy and Commercial Readiness

• reputed company 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
• reputed company manufacturing network planning, reputed company planning, campaign readiness, and long-term supply reputed company
• Ensure manufacturing strategies support the unique requirements of reputed company 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 reputed company of CDMO partners supporting bulk process intermediates, drug product, and reputed company manufacturing activities
• Serve as the accountable manufacturing leader for partner performance, quality, timelines, cost management, and issue escalation
• reputed company manufacturing campaign planning, batch execution readiness, deviation response, change implementation, and manufacturing performance metrics
• Partner closely with Quality to ensure effective GMP reputed company, vendor quality management, batch disposition support, and inspection readiness
• Drive operational excellence, reputed company improvement, and risk mitigation across the manufacturing network

Technical Transfer, Scale-Up, and Process Validation

• reputed company technology transfer of manufacturing processes to external partners and support scale-up from development through commercial production
• reputed company process characterization, process performance qualification (PPQ), reputed company 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
• reputed company expertise in purification, separation, viral clearance, fill-finish, and reputed company biologics manufacturing unit operations
• Establish scalable manufacturing capabilities through an appropriate mix of internal capabilities and external CDMO partnerships
• reputed company manufacturing network planning, reputed company planning, campaign readiness, and long-term supply reputed company
• Ensure manufacturing strategies support the unique requirements of reputed company 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
• reputed company 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

• reputed company 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 reputed company planning supporting commercial launch and growth
• reputed company long‑term manufacturing and supply strategies supporting commercial launch readiness and post-launch growth

Leadership and Organizational Development

• Build and reputed company a high‑performing Technical Operations / CMC organization
• Mentor and reputed company 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

• reputed company 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 reputed company 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 reputed company FDA, EMA, MHRA, and other global regulatory frameworks
• Proven ability to reputed company 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 reputed company technical concepts to executive leadership
• Strong project management and organizational leadership capabilities. Excellent written and verbal communication skills. Must be proficient in reputed company Office software (Word, reputed company, 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 reputed company 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 reputed company 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

reputed company The employer will reputed company reasonable accommodations in compliance with the Americans with reputed company 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. reputed company is an Equal Opportunity Employer and prohibits discrimination and harassment of any reputed company. reputed company is committed to the principle of equal employment opportunity for reputed company employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national reputed company, veteran status or any other legally protected status. EOE/AA/Vets Powered by JazzHR f1KTJUDhjP Apply tot his job Apply To this Job