Associate Director, External Manufacturing
Merck
Job Description The Global Pharmaceutical Organization (GPO) at our company is excited to invite passionate individuals to join our dynamic team! GPO is a diverse global organization committed to bringing a compliant, reliable supply of life‑saving and affordable medicines to patients around the world. Our organization is responsible for the manufacturing and supply of all pharmaceutical products, packaging of the entire Human Health portfolio and commercialization of the small molecule new product pipeline. GPO manages a wide range of products serving communities in more than 175 markets around the globe with more than 7 billion doses of vital medicine distributed each year. Collaborating with other operating units and functions, GPO's commitment to enhancing the patient experience and improving access to life‑saving treatments is achieved through a network of internal and external sites that support the enterprise and division’s strategic priorities. Our company's Small Molecule External Manufacturing organization is responsible for managing third‑party manufacturers of our products across drug substance, drug product and packaging operations. The organization helps launch and supply our critical medicines and vaccines around the world. The role of the Integrated Launch Excellence (ILE) platform within the organization focuses on the introduction, demonstration and validation of new products at external partners. External Manufacturing Operations Associate Director (Ops AD), in partnership with the respective functional representatives, is responsible for ensuring the reliable supply of quality products at competitive costs from external manufacturing partners (EPs) and for integrating these EPs into our company's supply chain appropriately. The Ops AD is the owner and primary point of contact for all interactions between our Manufacturing Division and EPs. Primary Responsibilities Dispute resolution with appropriate escalation Balancing our company's delivery requirements with contract manufacturer’s production plan and materials management (ERP transactions, logistics) Oversight of shop floor production, determining when an ExM functional representative should be deployed to the contract manufacturer’s facility Continuous improvement activities Partner with Procurement in the identification/selection of new contract manufacturers and negotiation/termination of supply agreements as required Facilitate collection of contract manufacturer capacity information (e.g., stated capacity, firm capacity, future capacity plans, lead times, comments/concerns), present to Supply Chain Management and drive recommendations for capacity expansion Ensure alignment of the Supply and Quality agreements Execute ERP transactions associated with receipt and movement of company‑owned inventory, book‑to‑physical reconciliation at contract manufacturers, and document and witness destruction of company‑owned inventory Ensure contract terms agreed upon by our company and the contract manufacturer (purchase orders, forecasts, deliveries, invoice payments) are executed in compliance with the Supply Agreement Collaborate with ExM Company Production System experts and other functions (technical, quality, procurement, etc.) to identify continuous improvement opportunities at contract manufacturers Project‑management support to the DP NA regional team and ensure greater coordination of ongoing projects within the region Travel up to 50% Education Minimum Requirement Bachelor’s degree minimum in Engineering, Medical, Science, Business, or related areas of study Required Experience and Skills No less than eight (8) years combined experience in commercial/business and manufacturing (operations, project management, quality, technology, supply chain, etc.) functions in pharmaceutical, chemical or related industry, or equivalent combination of education and experience Knowledge of drug substance manufacturing, including common unit operations and shop floor activities Excellent interpersonal, communication, project management, collaboration, negotiation, analytical and influencing skills Demonstrated strong leadership in a teamwork environment and strong team coordination abilities Cultural awareness and sensitivities Fluency in English, both verbal and written Preferred Experience and Skills Recent ExM Operations or site operations experience Conversant on domestic and foreign regulations and compendia governing manufacturing operations Lean project implementation experience Strong influencing skills demonstrated at various levels Management of critical sites in the U.S. for the Integrated Launch Excellence team Required Skills Adaptability API Manufacturing Business Management Contract Management Cultural Awareness Decision Making Interpersonal Relationships Inventory Management Invoice Processing Operational Strategies Process Improvements Procurement Production Scheduling Project Coordination Project Management Project Manufacturing Regulatory Compliance Risk Assessments Safety Management Supply Change Management Team Leadership Teamwork Vendor Management Preferred Skills Lean project implementation Leadership at various levels Salary and Benefits Salary range for this role is $129,000.00 – $203,100.00, with annual bonus and long‑term incentive eligibility where applicable. Benefits include medical, dental, vision, and other insurance for employee and family; retirement benefits, including 401(k); paid holidays; vacation; and compassionate and sick days. Equal Employment Opportunity We are an Equal Employment Opportunity Employer and provide equal opportunities to all employees and applicants for employment. We prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. Travel requirement is 25%. #J-18808-Ljbffr Merck
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