Director, External Manufacturing Operations

Primary Activities Include, But Are Not Limited To
- Lead an organization with direct oversight of the relationship with the CMO; serve as the “air traffic controller” for all information/interactions, establish boundaries and rules of engagement, manage issue escalation, and develop recommendations.
- Represent External Manufacturing on cross-functional teams (DCT, VCM, S&T, Procurement, Quality, and others) to enable stand-up and delivery transfers of pipeline programs.
- Accountable for operational activities, including:
- Compliance: Quality Risk management, Deviation Management, Product Release, Change Control.
- Meeting Demand and dispute resolution (with appropriate escalation).
- Production Planning & Materials Management (system data entries, logistics).
- Technology issues.
- Oversight of shop floor production; assess when an ExM functional lead should be deployed to the EP’s facility.
- Operational Excellence and Continuous Improvement.
- Linking end-to-end supply chain nodes to ensure/optimize flow of materials.
- Financial planning through participation in annual budget development.
- Build and maintain an interdependent relationship with the EP; “read a site,” anticipate risks/opportunities, and collaborate with site leadership.
- Steer issue escalation through a formal “Tier” process.
- Partner with Procurement, Quality, Technology, and Supply Chain on commercial aspects of the relationship lifecycle (Identify, Select, Negotiate, Develop, Terminate).
- Develop an integrated view of capacity across the external partner network; escalate risk; guide mitigation actions.
- Maintain Master Supply Agreement integrity and alignment with supply/quality agreements; ensure execution of contractual terms (purchase orders, forecasts, deliveries, approving invoice payments).
- Act as Production System (MPS) leader/coach for internal Focus Factory Teams and direct reports.
- Drive Integrated Risk Management across the EP network (risk assessments, prioritization, mitigation planning).
- Contribute to External Manufacturing Network Strategy and drive strategic initiatives.
- Plan strategically and understand the EP business environment and potential partners.
- Drive boundaryless collaboration and influence across all stakeholder levels.
- Lead special projects and assignments as needed.

Education
- Bachelor’s degree minimum in Engineering or Science (preferred).

Experience
- Minimum 10 years in small molecule drug substance and/or drug product manufacturing (operations, quality, or technology).

Required Experience
- GMP and EHS compliance goals via risk-based approach across Drug Substance and/or Drug Product.
- Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost, shortest lead-time.
- Management-level expertise in drug substance and drug product platforms.
- Proven record in planning and executing complex, multi-site technical transfers (New Product Introduction & Technical Transfer).
- Demonstrated leadership/management experience.
- Demonstrated experience managing a complex portfolio of projects.

Preferred Experience
- Business & financial acumen; apply economic/financial/industry data to drive value.
- Accomplishment-oriented; “business owner” mindset; influence without authority; effective in ambiguous/changing environments.
- Ability to work ambiguously: formulate plans, prioritize conflicting demands, act with urgency, and follow up effectively.
- Innovative thinking to experiment, learn, and adapt.

Enterprise Leadership Skills
- Influence; networking & partnerships; problem-solving/analytical skills in matrixed orgs; consensus building.
- Strong communication with senior management and all business levels.
- Collaborative with diverse stakeholders.
- Strategic planning and prioritization.

Required Skills
- 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

Application Instructions
- Apply through https://jobs.merck.com/us/en (or via Workday Jobs Hub for current employees). Application deadline is stated on the posting.