Director, External Manufacturing Operations

MSD

1d • Hybrid

About The Position

Our Company's Global Pharmaceutical Operations (GPO) External Manufacturing organization is responsible for management of contract manufacturing organizations (CMO) of our Company’s products across drug substance, drug product and packaging operations. The organization helps launch and supply our critical medicines and vaccines around the world. Within our GPO External Manufacturing organization, the Integrated Launch Excellence Platform is responsible for converting our pipeline to products through commercialization activities at CMOs for Drug Substance and Drug Products. Additionally, the Platform has responsibility for accelerating our regionalization strategies and in ensuring CMOs manufacturing our acquired assets are integrated into our external network. The scope of activity, along with the partner groups, encompasses strategic sourcing and technical transfer phased from pre-PPQ through post launch builds for sustained, reliable compliant supply at a competitive cost. The Director of Operations will interact with key operational and functional leaders and will be a leader for critical products and transfers focused on small molecule drug substance and/or drug products. The leader will be required to communicate, influence, and manage across the business as well as with partners in stakeholder organizations, such as Development & Commercialization Teams (DCT), Value Chain Management (VCM), Science & Technology (S&T), Procurement, Quality, and others to achieve outcomes. The incumbent and their team represent the primary point of contact for all dealings between the Company and the assigned CMO with emphasis on establishing a strong partnership as well as boundaries and ground rules of engagement founded on the spirit of contractual terms. These business relationships are typically highly complex in nature and of strategic importance, both to sustain the business and to grow the business. Primary activities include, but are not limited to: The candidate leads an organization with direct oversight of the relationship with the CMO. The role serves as the air traffic controller of all information / interactions between the Company and the CMO, establishes boundaries and rules of engagement, focusing on building the strength of the internal / external partnership, issue escalation of any type, and develops recommendations. Represents External Manufacturing operations on the cross-functional teams with DCT, VCM, S&T, VCM, and Procurement and others to enable stand-up and delivery transfers of the pipeline programs. The candidate is accountable for all operational related activities: Compliance (Quality Risk management, Deviation Management, Product Release, Change Control). Meeting Demand, Dispute Resolution (with appropriate escalation) Production Planning & Materials Management (system data entries, Logistics) Technology Issues Oversight of shop floor production (assessing when an ExM functional lead should be deployed to the EP’s facility) Operational Excellence and Continuous Improvement activities Linking end-to-end Supply Chain nodes to ensure and optimize flow of materials Responsible for Financial planning through active participation in the annual budget development process Builds a strong interdependent relationship with the EP, facilitates and engages directly with site leadership teams with a capability to "read a site" and anticipate both areas of risk and areas of opportunity, fostering an interdependent relationship based on high degrees of collaboration. Steers issue escalation though a formal “Tier” process Partners with Procurement, Quality, Technology and Supply Chain on commercial aspects of the relationship, including recommendations associated with any part of the relationship lifecycle and strategic considerations associated with the company’s Manufacturing and Supply Network evolution (Identify, Select, Negotiate, Develop, Terminate), as required. Develops an integrated view of capacity across the external partner network, escalates risk, develops recommendations, and guides execution of mitigation actions. Is accountable for maintaining the integrity of the Master Supply Agreements ensuring alignment with the Supply and Quality agreements, appropriate document revision and distribution control. Further ensures that the agreed-upon contractual terms are executed including purchase orders, forecasts, deliveries, and approving invoice payments. Acts as our company's Production System (MPS) leader & coach for our internal Focus Factory Teams and direct reports. Works with EP and our MPS resources, as needed, to identify operational excellence/ continuous improvement opportunities and supports implementation once approved. The ExM Operations Lead may commit resources provided the company and the EP would share in the costs and benefits of such operational improvements. Drives the development of an Integrated Risk Management program across the EP Network inclusive of risk assessments, prioritization, and mitigation planning. Contributes to the development of the External Manufacturing Network Strategy and drives strategic initiatives as an outcome. Plans strategically and understands the broad EP business environment and specific opportunities & potential partners in their operations area. Drives boundaryless collaboration, influence and connectivity by working directly with key internal stakeholders across all levels of management. Leads special projects and assignments as needed

Requirements

• Bachelor’s degree minimum in the Engineering or Science preferred
• Minimum ten (10) years' experience in small molecule drug substance and/or drug product manufacturing (operations, quality, or technology).
• Compliance – Has experience and ability to achieve GMP and EHS compliance goals, through a risk-based approach across Drug Substance and/or Drug Product
• Operational Excellence– Has proven Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.
• Depth of Manufacturing Knowledge – Has proven skills and expertise at management level drug substance and drug product platforms.
• New Product Introduction & Technical Transfer – Has proven record, skills and expertise in planning and executing complex, multi-site technical transfers
• Demonstrated experience in management/leadership positions.
• Demonstrated experience in managing a complex portfolio of projects.
• Cross-Cultural Awareness
• Data-Driven Decision Making
• Drug Product Manufacturing
• External Manufacturing
• GMP Compliance
• Innovation
• Operational Excellence
• Process Improvements
• Procurement
• Production Management
• Production Planning
• Small Molecules
• Strategic Thinking

Nice To Haves

• Business & Financial Acumen – Has skills to understands and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
• Candidate must be accomplishment oriented (self-motivated and persistent), possess a "business owner" mentality, possess the ability to influence without authority, and demonstrate the ability to effectively operate in an ambiguous/changing environment.
• Ability to work in ambiguous situations, formulate a plan, focus on what matters, drive outcomes, and speak up and be open-minded.
• Ability to prioritize conflicting demands, act with urgency, when necessary, effective follow-ups on tasks and activities.
• Innovative thinking to experiment, learn and adapt new ways of working and initiatives supporting the strategy.
• Enterprise Leadership Skills: Influence - Using effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.
• Networking & Partnerships - Building partnerships; developing and leveraging relationships within and across internal and external teams
• Effective problem-solving and analytical skills, successfully navigating matrixed organizations, building consensus and influencing decision-making.
• Strong communication skills to effectively engage with senior management and across all levels of the business.
• Collaborative nature, with the ability to work with diverse personalities and collaborate effectively with various functions and stakeholders.
• Strategic Planning - Prioritizing and planning; establishing an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines and leveraging resources.

Responsibilities

• Leads an organization with direct oversight of the relationship with the CMO.
• Represents External Manufacturing operations on the cross-functional teams with DCT, VCM, S&T, VCM, and Procurement and others to enable stand-up and delivery transfers of the pipeline programs.
• Accountable for all operational related activities: Compliance (Quality Risk management, Deviation Management, Product Release, Change Control).
• Meeting Demand, Dispute Resolution (with appropriate escalation)
• Production Planning & Materials Management (system data entries, Logistics)
• Technology Issues Oversight of shop floor production (assessing when an ExM functional lead should be deployed to the EP’s facility)
• Operational Excellence and Continuous Improvement activities
• Linking end-to-end Supply Chain nodes to ensure and optimize flow of materials
• Responsible for Financial planning through active participation in the annual budget development process
• Builds a strong interdependent relationship with the EP, facilitates and engages directly with site leadership teams with a capability to "read a site" and anticipate both areas of risk and areas of opportunity, fostering an interdependent relationship based on high degrees of collaboration.
• Steers issue escalation though a formal “Tier” process
• Partners with Procurement, Quality, Technology and Supply Chain on commercial aspects of the relationship, including recommendations associated with any part of the relationship lifecycle and strategic considerations associated with the company’s Manufacturing and Supply Network evolution (Identify, Select, Negotiate, Develop, Terminate), as required.
• Develops an integrated view of capacity across the external partner network, escalates risk, develops recommendations, and guides execution of mitigation actions.
• Accountable for maintaining the integrity of the Master Supply Agreements ensuring alignment with the Supply and Quality agreements, appropriate document revision and distribution control.
• Further ensures that the agreed-upon contractual terms are executed including purchase orders, forecasts, deliveries, and approving invoice payments.
• Acts as our company's Production System (MPS) leader & coach for our internal Focus Factory Teams and direct reports.
• Works with EP and our MPS resources, as needed, to identify operational excellence/ continuous improvement opportunities and supports implementation once approved.
• Drives the development of an Integrated Risk Management program across the EP Network inclusive of risk assessments, prioritization, and mitigation planning.
• Contributes to the development of the External Manufacturing Network Strategy and drives strategic initiatives as an outcome.
• Plans strategically and understands the broad EP business environment and specific opportunities & potential partners in their operations area.
• Drives boundaryless collaboration, influence and connectivity by working directly with key internal stakeholders across all levels of management.
• Leads special projects and assignments as needed

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees