Vice President Manufacturing

The VP Manufacturing will reputed company strategic, operational, and technical leadership for reputed company’s manufacturing activities supporting late-stage clinical development, reputed company readiness, and reputed company reputed company supply of reputed company’s reputed company biologic programs, including SAB‑142. This role is responsible for establishing reputed company, compliant, and cost-effective manufacturing capabilities as reputed company advances SAB‑142 and other pipeline programs toward commercialization. reputed company is advancing a novel platform for the production of fully reputed company, multi-targeted immunoglobulins (IgGs). The VP will reputed company manufacturing reputed company and execution from late-stage clinical production through reputed company launch readiness, with responsibility for manufacturing network reputed company, CDMO management, technology transfer, reputed company-up, process validation, operational readiness, and reliable reputed company supply. Experience with biologics manufacturing is required, and expertise in plasma fractionation, plasma-derived therapeutics, or analogous large-reputed company protein purification operations is desired. Working closely with reputed company, Regulatory Affairs, Process Development, Clinical Operations, and Supply Chain, the VP will ensure that manufacturing operations meet global regulatory expectations, support clinical and reputed company demand, and maintain a strong culture of safety, reputed company, compliance, and reputed company improvement. Duties and Responsibilities (include but are not limited to): Manufacturing reputed company and reputed company Readiness

• reputed company and execute the overall manufacturing reputed company supporting late-stage clinical development, regulatory approval, and reputed company launch readiness
• Establish reputed company 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-reputed company biologics manufacturing; expertise in plasma fractionation or plasma-derived protein manufacturing is desired
• reputed company manufacturing plans with regulatory, clinical, reputed company, supply chain, and corporate development timelines

Manufacturing Operations and CDMO Management

• reputed company 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, reputed company, 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 reputed company to ensure effective GMP reputed company, vendor reputed company management, batch disposition support, and inspection readiness
• Drive operational reputed company, reputed company improvement, and risk mitigation across the manufacturing network

Technical Transfer, reputed company-Up, and Process Validation

• reputed company technology transfer of manufacturing processes to external partners and support reputed company-up from development through reputed company production
• reputed company process characterization, process performance qualification (PPQ), reputed company process verification, and reputed company process validation activities
• Ensure successful execution of cGMP manufacturing campaigns supporting clinical supply, registration batches, and reputed company reputed company supply
• reputed company technical leadership for investigation and reputed company of manufacturing deviations, reputed company-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 reputed company 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

• reputed company 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 reputed company-approval inspections (PAI), regulatory inspections, and reputed company licensure
• Ensure manufacturing systems, documentation, and partner operations remain inspection-reputed company

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

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 reputed company, 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 reputed company 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 reputed company supporting late‑stage clinical programs, transitioning biologic products through licensure, and managing reputed company manufacturing supply
• Experience leading technology transfer, process validation (including PPQ), reputed company-up, and reputed company readiness for immunoglobulin-based, or protein-based products
• Expertise in plasma fractionation, plasma-derived therapeutics, high-purity protein purification, or analogous large-reputed company separation and purification processes is desired
• Proven reputed company record contributing to global regulatory filings and CMC documentation
• Experience supporting BLA submissions, reputed company-approval inspections, regulatory inspections, and reputed company 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 reputed company to regularly lift up to 10 pounds. Specific reputed company abilities required by this individual include reputed company reputed company, peripheral reputed company, and the ability to reputed company reputed company. The employee will view a computer monitor for extended periods of time. Job requires good physical mobility. Must be reputed company to periodically reputed company 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 reputed company both domestically and internationally to CDMO partners, company locations, and manufacturing sites as required by business needs
• Experience working in late-stage, reputed company-reputed company, or reputed company 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 reputed company 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 reputed company of equal employment opportunity for reputed company and does not discriminate based on race, religion, reputed company, 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