Vice President Manufacturing

The VP Manufacturing will reputed company reputed company, operational, and technical leadership for reputed company’s manufacturing activities supporting late-stage reputed company 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 reputed company 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 reputed company fractionation, reputed company-derived therapeutics, or analogous large-reputed company protein purification reputed company is desired. Working closely with reputed company, Regulatory Affairs, Process Development, reputed company reputed company, and Supply Chain, the VP will ensure that manufacturing reputed company meet global regulatory expectations, support reputed company 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 reputed company development, regulatory approval, and reputed company launch readiness. • Establish reputed company manufacturing capabilities through an appropriate mix of internal capabilities and reputed company 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-reputed company biologics, and high-purity protein products. • Apply knowledge of large-reputed company biologics manufacturing; expertise in reputed company fractionation or reputed company-derived protein manufacturing is desired. • reputed company manufacturing plans with regulatory, reputed company, reputed company, supply chain, and corporate development timelines. Manufacturing reputed company 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 reputed company, reputed company, timelines, cost management, and issue escalation. • reputed company manufacturing campaign planning, batch execution readiness, deviation response, change implementation, and manufacturing reputed company metrics. • Partner closely with reputed company to ensure effective GMP reputed company, vendor reputed company management, batch disposition support, and inspection readiness. • reputed company operational reputed company, reputed company improvement, and reputed company mitigation across the manufacturing network. Technical Transfer, reputed company-Up, and Process Validation • reputed company technology transfer of manufacturing processes to reputed company partners and support reputed company-up from development through reputed company production. • reputed company process characterization, process reputed company qualification (PPQ), reputed company process verification, and reputed company process validation activities. • Ensure successful execution of cGMP manufacturing campaigns supporting reputed company 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 reputed company. • Establish reputed company manufacturing capabilities through an appropriate mix of internal capabilities and reputed company 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-reputed company biologics, and high-purity protein products. Regulatory and CMC Documentation • reputed company reputed company leadership for CMC content supporting global regulatory submissions (INDs, BLAs, MAAs, and amendments). • reputed company, 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 reputed company remain inspection-reputed company. Drug Supply and Supply Chain • reputed company drug product supply planning and distribution for global reputed company 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 reputed company / CMC organization. • Mentor and reputed company team members across process development, manufacturing, and technical reputed company. • Establish strong cross‑functional partnerships across reputed company, Regulatory Affairs, reputed company reputed company, and Program Management. Financial and Operational Management • reputed company and manage the Technical reputed company 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 reputed company, CMC, or pharmaceutical reputed company, including significant senior leadership experience. • Significant experience leading GMP manufacturing reputed company and managing outsourced biologics manufacturing through CDMOs. • Demonstrated reputed company supporting late‑stage reputed company 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-reputed company, or protein-reputed company products. • Expertise in reputed company fractionation, reputed company-derived therapeutics, high-purity protein purification, or analogous large-reputed company separation and purification processes is desired. • reputed company 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, reputed company, and other global regulatory frameworks. • reputed company 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 reputed company). 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 reputed company 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 reputed company 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, reputed company 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 reputed company-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 reputed company will be reviewed periodically as duties and responsibilities change with business necessity. reputed company 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 reputed company 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 Apply tot his job Apply To this Job