Vice President, Manufacturing – Technical Operations

Asahi Kasei

. Lead external manufacturing and technical operations across the product lifecycle from early-stage development through commercialization and post-approval support .

Posted 10/23/2026full-timeCary • North Carolina • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in CMC, pharmaceutical development, and manufacturing, with a strong focus on regulatory compliance, process validation, and lifecycle management. Proven ability to lead external manufacturing operations and manage CDMO relationships effectively while ensuring product quality and timely delivery.

Highest-signal resume keywords

CMC ExpertiseRegulatory SubmissionsCGMP ComplianceProcess ValidationCDMO Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process DevelopmentTechnology TransferScale-UpManufacturing StrategiesRisk AssessmentAnalytical ControlQuality SystemsProduction SchedulingValidation ActivitiesLifecycle Management

Soft Skills

LeadershipCollaborationNegotiationCommunicationDecision-Making

Industry Keywords

Pharmaceutical DevelopmentManufacturing PlatformsDrug SubstanceDrug ProductQuality AgreementsCAPAsInvestigationsChange ControlsTechnical OperationsVendor Management

About the role

Key responsibilities & impact

Lead external manufacturing and technical operations across the product lifecycle from early-stage development through commercialization and post-approval support
Provide strategic and technical oversight of the CDMO network to ensure compliant, reliable, timely, and cost-effective product supply
Establish manufacturing strategies, plans, production schedules, capacity requirements, and supply-risk mitigation strategies
Lead manufacture and packaging of clinical and commercial products through external partners
Provide on-site technical oversight at CDMOs during critical manufacturing, validation, technology-transfer, inspection-readiness, and troubleshooting activities
Lead process development, scale-up, technology transfer, qualification, and validation activities
Evaluate, select, qualify, and onboard new CDMOs
Drive lifecycle improvements in process robustness, yield, capacity, reliability, and cost-effectiveness
Establish CDMO requirements, deliverables, timelines, governance, escalation pathways, and performance accountability
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 approval changes
Assess technical and regulatory impacts of proposed changes to processes, analytical methods, packaging, equipment, sites, or suppliers
Support regulatory and pre-approval inspections through technical preparation, documentation readiness, and subject-matter-expert participation
Author, review, and approve technical documents including protocols, reports, master batch records, risk assessments, investigations, change controls, and Technical Operations procedures
Partner with Quality Assurance on CDMO qualification, audits, compliance oversight, and inspection readiness
Conduct technical and CMC due diligence for acquisitions, licensing opportunities, partnerships, and new product opportunities
Develop and manage Technical Operations budgets, forecasts, vendor commitments, and project expenditures
Establish performance metrics and communicate program status, risks, decisions, and resource needs to stakeholders and leadership
Maintain current knowledge of scientific advances, industry practices, and regulatory expectations related to CMC, manufacturing, packaging, and analytical control

Requirements

What you’ll need

Bachelor’s degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, or a related scientific or engineering discipline
At least 15 years of progressively responsible experience in CMC, pharmaceutical development, manufacturing, or Technical Operations, including experience leading programs in an outsourced manufacturing environment
Broad experience across multiple product modalities and manufacturing platforms
Strong understanding of drug substance and drug product development, process scale-up, technology transfer, process validation, commercial manufacturing, packaging, and lifecycle management
Demonstrated ability to apply technical knowledge across different modalities and quickly assess unfamiliar manufacturing processes, technologies, and product platforms
Strong knowledge of global CMC requirements and experience supporting regulatory submissions, agency interactions, inspections, and pre- and post-approval changes
Thorough understanding of cGMP requirements, pharmaceutical quality systems, deviations, investigations, change controls, CAPAs, and manufacturing risks
Demonstrated success managing CDMOs and holding external partners accountable for performance
Strong scientific judgment, root-cause analysis, risk evaluation, and timely decision-making skills
Ability to lead multiple complex programs, establish priorities, manage competing demands, and deliver results in a dynamic, cross-functional environment
Excellent leadership, collaboration, negotiation, and communication skills
Strong written and verbal communication skills, including presenting complex technical matters clearly to executive leadership, regulatory authorities, partners, and nontechnical audiences
Ability to travel 30% domestically and internationally

Benefits

Comp & perks

Hybrid work arrangement
Travel requirements: 30% domestic and international
Equal opportunity employer
Diverse workforce commitment