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Sanford, Florida, United States
Onsite
Kyowa Kirin is a global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation, dedicated to discovering and advancing treatments for diseases in which unmet need is greatest. Based in Japan with worldwide operations, we work across the continuum from drug discovery to commercialization, guided by our commitment to patients and their families.
Our research teams, located in California and around the world, are focused on developing the next generation of antibody, cell, and gene therapies, with particular emphasis on bone and mineral disorders, hemato-oncology, and rare diseases. We accelerate development through collaborations with industry, academia, patients, and healthcare providers, and since 2018 we have introduced four new therapies serving patients with progressive illnesses often in need of new therapeutic alternatives.
Our culture is grounded in our values: Commitment to Life, Integrity, Innovation, and Teamwork/Wa, and brought to life through the Kabegoe Principles, which define the behaviors and actions that guide how we work together to deliver meaningful impact for patients.
We’re proud of the progress we’ve made and mindful of the countless individuals still waiting for their own breakthroughs. A commitment to making people smile unites our efforts. Learn more at www.kkna.kyowakirin.com.
Summary:
The Senior Manager, Supply Chain is responsible, initially, for driving Supply Chain operational readiness activities enabling Sanford, NC facility start up in 2027; then thereafter will be primarily responsible for owning the strategic and operational leadership across warehouse operations, materials management, internal logistics, production material flow, supply planning, and GMP compliance. Acting as the key contributor representing the site in our regional / global S&OP, S&OE governance bodies ensuring reliable and compliant supply to support commercial and clinical manufacturing. In addition to supply planning and warehouse elements, this role is responsible for the enablement and adoption of digital capabilities and the business processes they support – primarily ERP & digital planning tools, in support of the site’s “digital first” philosophy.
Essential Functions:
• Responsible for establishing, qualifying, and leading Sanford's GMP-compliant warehouse and materials management organization while providing governance and leadership for site planning processes, inventory strategy, ERP business processes, and operational readiness activities supporting drug substance manufacturing.
• Support all greenfield activities for the development and onboarding of Supply Chain and Warehouse operations for the Sanford Manufacturing site, ensuring efficiency and compliance with company / regulatory standards.
• Lead the development and oversight of all warehouse operations (receiving, put‑away, picking, shipping, internal material movements).
• Oversee warehouse safety programs, equipment certifications and licenses, and warehouse regulatory compliance.
• Develop and maintain warehouse SOPs, work instructions, and training programs.
• Lead Warehouse Qualification and ensure full compliance with GMP, GDP, GxP, and Kyowa Kirin quality standards across all material handling activities.
• Maintain inspection readiness for internal, external, and regulatory audits.
• Support Operational Readiness from a Supply Chain and Warehouse Operations perspective inclusive of logistics route risk assessment, lane ship studies, ensuring systems and processes are fully prepared for go-live and ongoing operations.
• Develop and govern the process through which production schedules are developed and managed within the value streams, including prioritization logic, constraint management, process controls and flex/buffer strategies while achieving company revenue goals, customer service goals, inventory and lean productivity goals.
• Understand and highlight capacity constraints and work collaboratively with Manufacturing, Process Engineering, MSAT and Quality on resolution across resources and to resolve bottlenecks.
• Develop and implement inventory management strategies that support revenue growth, minimize risk of Excess and Obsolescence for both finished goods and raw materials, while balancing inventory turns and availability goals.
• Responsible for planning governance, inventory strategy, and escalation management for monthly demand/supply planning activities for products manufactured at the site, aligned with global S&OP/S&OE processes.
• Drive proactive communication with suppliers and internal stakeholders to mitigate supply risks and maintain continuity of operations.
• Development of Cycle Counting process & Physical inventory reconciliation governance with Finance
• Lead and manage the business ERP system updates and enhancement with configuration development, impact assessment, & optimization of business process flowsbetween impacted integrated digital systems
• Establishes change management plans for ERP update deployments, identify required SOP/WI updates, execute UAT’s and user adoption and training activities.
• Establishes, monitors and improves business performance metrics and improvement targets to ensure best in class operations are realized.
Requirements:
Education
Bachelor’s Degree Required, with focus in Supply Chain Management, Industrial Engineering, or other business management subject area or related field.
Experience
5+-8 years direct Supply Chain Management / Operations experience ideally within Life Sciences manufacturing, or highly regulated industry, preferably within a manufacturing site environment. Experience with starting up and operating a biopharma manufacturing facility is a strongly preferred.
Technical Skills
• Deep knowledge in planning processes: S&OP, New Product Introduction, Supply, Material & Inventory Planning, Warehouse Operations and Compliance
• High Level of Proficiency using and driving effectivity of ERP, proficiency with Microsoft D365 a plus.
• Data Analysis, Digital Automation experience
• Knowledge of continuous improvement / process improvement methodologies and tools (such as LEAN Six Sigma, Kaizen, and Value Stream Mapping)
• Ability to translate technical and business languages to different stakeholders effectively.
• Familiarity with implementing systems and business processes aligned with requirements for highly regulated industries (GMP, GDP, CSV, etc)
Non-Technical Skills
• Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives.
• Respond promptly, take accountability, and manage tasks efficiently.
• Solutions minded with strong critical thinking & analytical skills
• Strong Interpersonal & communication skills are required.
• Risk/Resiliency Modeling & Contingency Planning
• Ability to thrive in a matrixed, diverse-culture environment
• Desires to be part of a High-Performing Team and to promote the development of High-Performing team members.
Physical Demands:
Initially working in an office setting and construction site and ultimately in a biotech manufacturing site in Sanford, NC.
Working Conditions:
Work is 100% on-site. Requires up to 10% domestic and international travel
The anticipated salary for this position will be $____ to $____. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
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#LI-TT1 #On-Site #Sanford #North Carolina