Vice President, Manufacturing

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver strategic, operational, and technical direction for the company’s manufacturing initiatives.

• Create scalable, compliant, and cost-efficient manufacturing capabilities.

• Spearhead manufacturing network strategy, manage CDMO relationships, oversee technology transfer, scale-up, process validation, operational readiness, and ensure consistent commercial supply.

• Guarantee that manufacturing operations align with global regulatory standards while fostering a robust culture of safety, quality, compliance, and continuous improvement.

• Formulate and implement the comprehensive manufacturing strategy to support late-stage clinical development and prepare for commercial launch readiness.

• Provide executive leadership and supervision of CDMO partners involved in bulk process intermediates and drug product manufacturing activities.

• Supervise the technology transfer of manufacturing processes to external partners and facilitate scale-up from development to commercial production.

• Ensure the successful execution of cGMP manufacturing campaigns that support clinical supply and future commercial supply.

⛳️ Requirements

• A Ph.D. in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related field is preferred.

• An advanced scientific degree is strongly preferred.

• Over 15 years of progressive experience in biologics manufacturing, technical operations, CMC, or pharmaceutical operations.

• Extensive experience in leading GMP manufacturing operations and managing outsourced biologics manufacturing through CDMOs.

• Proven success in supporting late-stage clinical programs.

• Experience in leading technology transfer, process validation, scale-up, and commercial readiness for immunoglobulin-based or protein-based products.

• Desired expertise in plasma fractionation, plasma-derived therapeutics, high-purity protein purification, or similar large-scale separation and purification processes.

• A proven history of contributing to global regulatory filings and CMC documentation.

• Strong preference for experience in supporting BLA submissions, pre-approval inspections, regulatory inspections, and activities related to commercial launch readiness.

• Significant experience in building and leading high-performing technical teams.

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Professional development