Merck
Associate Director, External Manufacturing Operations - Medical Devices
Merck, Rahway, New Jersey, us, 07065
Overview
Associate Director, External Manufacturing Operations - Medical Devices. The role serves as a Virtual Plant Manager responsible for leading a cross-functional team in oversight of relationships with External Partners that manufacture, assemble, and test complex injection molded Device Components, Device Constituents, and Medical Devices used to deliver Pharmaceutical, Biologic, and Vaccine Products. The position supports a "Safety First, Quality Always" mindset and acts as the primary point of contact between the Company and External Partners to ensure excellence in Compliance, Supply, Continuous Improvement, and Cost Management. The role may assist in commercialization activities for New Product Introductions requiring complex devices and novel technologies, and involves collaboration with Research, Manufacturing, and Commercial Operations teams.
Responsibilities
Lead an Integrated Cross-Functional Team in delivery of reliable and compliant supply. Build a strong interdependent relationship with External Partner site and Plant Leadership Team. Create and maintain an inclusive, high-performing team culture; coach team members as required. Ensure a "Right First Time" mindset; consistently deliver On-Time and In-Full with First Pass Quality. Provide oversight and presence on the production floor at External Partner sites. Maintain adherence to terms in the Supply Agreement and Quality Agreement, ensuring alignment with the Master Supply Agreement (MSA). Lead issue resolution and escalation when required; manage disputes as appropriate. Resolve technical issues including investigations, CAPAs, process improvements, source changes, technical transfers, equipment maintenance, reliability, and lifecycle management. Lead periodic business and operations review meetings with External Partners. Compliance: Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control). Supply Chain Management: Coordinate End-to-End Product Supply Chain activities to ensure timely and optimized material flow (Demand Management, E2E Production Planning, Materials Management, Logistics, SAP entries as needed). Continuous Improvement: Assess current conditions and risks at External Partner site; establish baseline KPIs and trends; formulate actionable improvement plans. Financial Stewardship: Manage budgets, estimates, and accruals; provide input into annual ExM Operations Profit Planning. Commercialization of New Products: Support sourcing and siting activities, evaluate supplier capabilities, participate in on-site due diligence, and input into Supply and Quality Agreements. Launch Supply Risk Mitigation: Ensure External Partner Site Readiness, assist with technology transfer, develop and execute manufacturing process robustness plans, and provide production oversight. Education and Experience
Bachelor’s Degree required; Engineering or Science preferred. Required Experience and Skills
No less than eight (8) years in Biopharmaceutical industry across multiple manufacturing disciplines; at least five (5) years leading teams or projects; at least three (3) years in direct shop floor production management. Project Management: Proficient with Microsoft Project, OneNote, Teams, SharePoint, Action Trackers, Risk Trackers, Decision Logs, etc. Communication: Excellent written and verbal communication; ability to influence senior and executive stakeholders. Integrity: Stewardship of Intellectual Property; maintain confidentiality with multiple internal and external stakeholders. Supplier Relationship Management: Ability to manage and influence supplier relationships. Business & Financial Acumen: Forecast and manage budgets; understand industry and economic data to drive value. Compliance: Deep understanding of GMP and Environment & Safety Regulations. Deep Manufacturing Knowledge: Expertise in manufacturing processes, equipment, labor relations, and production best practices. World Class Supplier Mindset: Deliver compliant supply with high quality, cost efficiency, and lead-time optimization. Strategic Thinking: Identify value-adding opportunities and proactively mitigate risk across the value chain. Working Across Boundaries: Strong interpersonal and networking skills to collaborate with internal and external partners. Drive Results: Leverage manufacturing, technical, and quality operations to achieve business outcomes. End-to-End Mindset: Apply understanding of end-to-end supply chain to optimize results. International Experience: Ability to engage across diverse cultures. Preferred Experience and Skills
Manufacturing: Injection molding, automated assembly of medical device components; final assembly and packaging of combination products; experience with OEB 4/5 is a plus. New Product Introductions: Knowledge of pharmaceutical development and commercialization; MDCP development experience is a plus. Process Improvement: Lean principles, equipment design, preventative maintenance. Regulatory: Global regulatory requirements for MDCP development and manufacturing (e.g., 21 CFR Part 4, MDR, ISO 13485:2016, EU MDR). Strategic Sourcing and Contract Negotiation. Requisition ID
P-100912
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Associate Director, External Manufacturing Operations - Medical Devices. The role serves as a Virtual Plant Manager responsible for leading a cross-functional team in oversight of relationships with External Partners that manufacture, assemble, and test complex injection molded Device Components, Device Constituents, and Medical Devices used to deliver Pharmaceutical, Biologic, and Vaccine Products. The position supports a "Safety First, Quality Always" mindset and acts as the primary point of contact between the Company and External Partners to ensure excellence in Compliance, Supply, Continuous Improvement, and Cost Management. The role may assist in commercialization activities for New Product Introductions requiring complex devices and novel technologies, and involves collaboration with Research, Manufacturing, and Commercial Operations teams.
Responsibilities
Lead an Integrated Cross-Functional Team in delivery of reliable and compliant supply. Build a strong interdependent relationship with External Partner site and Plant Leadership Team. Create and maintain an inclusive, high-performing team culture; coach team members as required. Ensure a "Right First Time" mindset; consistently deliver On-Time and In-Full with First Pass Quality. Provide oversight and presence on the production floor at External Partner sites. Maintain adherence to terms in the Supply Agreement and Quality Agreement, ensuring alignment with the Master Supply Agreement (MSA). Lead issue resolution and escalation when required; manage disputes as appropriate. Resolve technical issues including investigations, CAPAs, process improvements, source changes, technical transfers, equipment maintenance, reliability, and lifecycle management. Lead periodic business and operations review meetings with External Partners. Compliance: Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control). Supply Chain Management: Coordinate End-to-End Product Supply Chain activities to ensure timely and optimized material flow (Demand Management, E2E Production Planning, Materials Management, Logistics, SAP entries as needed). Continuous Improvement: Assess current conditions and risks at External Partner site; establish baseline KPIs and trends; formulate actionable improvement plans. Financial Stewardship: Manage budgets, estimates, and accruals; provide input into annual ExM Operations Profit Planning. Commercialization of New Products: Support sourcing and siting activities, evaluate supplier capabilities, participate in on-site due diligence, and input into Supply and Quality Agreements. Launch Supply Risk Mitigation: Ensure External Partner Site Readiness, assist with technology transfer, develop and execute manufacturing process robustness plans, and provide production oversight. Education and Experience
Bachelor’s Degree required; Engineering or Science preferred. Required Experience and Skills
No less than eight (8) years in Biopharmaceutical industry across multiple manufacturing disciplines; at least five (5) years leading teams or projects; at least three (3) years in direct shop floor production management. Project Management: Proficient with Microsoft Project, OneNote, Teams, SharePoint, Action Trackers, Risk Trackers, Decision Logs, etc. Communication: Excellent written and verbal communication; ability to influence senior and executive stakeholders. Integrity: Stewardship of Intellectual Property; maintain confidentiality with multiple internal and external stakeholders. Supplier Relationship Management: Ability to manage and influence supplier relationships. Business & Financial Acumen: Forecast and manage budgets; understand industry and economic data to drive value. Compliance: Deep understanding of GMP and Environment & Safety Regulations. Deep Manufacturing Knowledge: Expertise in manufacturing processes, equipment, labor relations, and production best practices. World Class Supplier Mindset: Deliver compliant supply with high quality, cost efficiency, and lead-time optimization. Strategic Thinking: Identify value-adding opportunities and proactively mitigate risk across the value chain. Working Across Boundaries: Strong interpersonal and networking skills to collaborate with internal and external partners. Drive Results: Leverage manufacturing, technical, and quality operations to achieve business outcomes. End-to-End Mindset: Apply understanding of end-to-end supply chain to optimize results. International Experience: Ability to engage across diverse cultures. Preferred Experience and Skills
Manufacturing: Injection molding, automated assembly of medical device components; final assembly and packaging of combination products; experience with OEB 4/5 is a plus. New Product Introductions: Knowledge of pharmaceutical development and commercialization; MDCP development experience is a plus. Process Improvement: Lean principles, equipment design, preventative maintenance. Regulatory: Global regulatory requirements for MDCP development and manufacturing (e.g., 21 CFR Part 4, MDR, ISO 13485:2016, EU MDR). Strategic Sourcing and Contract Negotiation. Requisition ID
P-100912
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