Vice President, 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

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Materials, Homes, and Health Care , contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Asahi Kasei Therapeutics is the global specialty pharmaceutical business of Asahi Kasei. We are a commercial-stage company committed to positively impacting health by expanding therapeutic options that improve the lives of patients around the world. Drawing upon our strong heritage of scientific innovation, we aim to help reshape care in transplantation, nephrology, immunology, infectious diseases and other underserved conditions.

Job Description

The Vice President, Manufacturing and Technical Operations is responsible for leading the Company's external manufacturing and technical operations activities across the product lifecycle, from early-stage development through commercialization and post-approval support. Operating within a fully outsourced manufacturing model, this role provides strategic and technical oversight of the Company's CDMO network to ensure compliant, reliable, timely, and cost-effective product supply. The Vice President establishes manufacturing strategies, directs process development and technology transfer, oversees manufacturing execution and lifecycle management, and proactively manages technical and supply risks. The role serves as the primary senior-level interface with CDMOs and license partners and is accountable for partner performance, issue escalation, and delivery against Company objectives. Working cross-functionally with Supply Chain, Quality, Regulatory Affairs, Clinical Development, and other functions, the Vice President leads complex programs through execution and ensures manufacturing plans remain aligned with the Company's portfolio priorities, regulatory commitments, clinical needs, and commercial goals.

Summary of Key Responsibilities

• Lead the manufacture and packaging of the Company's clinical and commercial products through external partners, ensuring compliant, reliable, and timely supply across applicable markets.
• Establish manufacturing plans, production schedules, capacity requirements, and supply-risk mitigation strategies in collaboration with Supply Chain, Quality, Regulatory Affairs, and other relevant functions.
• Provide on-site technical oversight at CDMOs during critical manufacturing, validation, technology-transfer, inspection-readiness, or troubleshooting activities, as required.
• Lead phase-appropriate process development, scale-up, technology transfer, qualification, and validation activities for manufacturing and packaging operations.
• Lead the technical evaluation, selection, qualification, and onboarding of new CDMOs, ensuring activities meet regulatory, quality, timeline, supply, and budget requirements.
• Drive lifecycle improvements that enhance process robustness, yield, capacity, reliability, and cost-effectiveness.
• Establish clear requirements, deliverables, timelines, governance, and escalation pathways with CDMOs and hold partners accountable for performance.
• Ensure manufacturing and packaging operations comply with cGMP, approved processes, regulatory filings, quality agreements, and Company requirements.
• Author and review manufacturing and technical content for regulatory submissions, agency responses, and pre- and post-approval changes in collaboration with Regulatory Affairs.
• Assess the technical and regulatory impact of proposed changes to processes, analytical methods, packaging, equipment, sites, or suppliers.
• Support regulatory inspections and pre-approval inspections by coordinating technical preparation, documentation readiness, and subject-matter-expert participation.
• Author, review, and approve technical documents within delegated authority, including protocols, reports, master batch records, risk assessments, investigations, change controls, and Technical Operations procedures.
• Partner with Quality Assurance to support CDMO qualification, audits, compliance oversight, and inspection readiness while maintaining appropriate independence of Quality decision-making.
• Conduct technical and CMC due diligence for potential acquisitions, licensing opportunities, partnerships, and new product opportunities, identifying key risks, costs, timelines, and resource requirements.
• Develop and manage Technical Operations budgets, forecasts, vendor commitments, and project expenditures, ensuring financial discipline and accurate invoicing.
• Establish performance metrics and communicate program status, risks, decisions, and resource needs to internal stakeholders and leadership.
• Maintain current knowledge of relevant scientific advances, industry practices, and regulatory expectations related to CMC, manufacturing, packaging, and analytical control.

Required Qualifications and Skills

• Bachelor's deg