VP, External Manufacturing & Technical Operations

AK America; Cary (NC); On-site; USD 250,000 - 400,000; Full time

Job summary

Asahi Kasei Therapeutics seeks a Vice President of Manufacturing and Technical Operations to lead its outsourced manufacturing network across the product lifecycle, from development to post-approval support. The role provides strategic oversight of CDMOs, ensuring compliant, reliable, timely, and cost-effective product supply while coordinating with cross-functional teams.

The candidate will drive manufacturing strategies, technology transfer, process development, and lifecycle management, with

Responsibilities

• Lead external manufacturing and packaging of clinical and commercial products with CDMOs.
• Establish manufacturing plans, schedules, capacity, and supply-risk mitigation with cross-functional teams.
• Provide on-site technical oversight at CDMOs during critical manufacturing, validation, and inspections.
• Lead phase-appropriate process development, scale-up, technology transfer, qualification, and validation activities.
• Source, evaluate, qualify, and onboard new CDMOs to meet regulatory, quality, timeline, and budget requirements.
• Drive improvements in process robustness, yield, capacity, reliability, and cost-effectiveness.

Education

Bachelor's deg

Job description

Asahi Kasei Therapeutics seeks a Vice President of Manufacturing and Technical Operations to lead its outsourced manufacturing network across the product lifecycle, from development to post-approval support. The role provides strategic oversight of CDMOs, ensuring compliant, reliable, timely, and cost-effective product supply while coordinating with cross-functional teams.

The candidate will drive manufacturing strategies, technology transfer, process development, and lifecycle management, with