Director, External Manufacturing Operations

Primary Activities (including but not limited to)
- Lead the organization with direct oversight of the External Manufacturing (CMO/EP) relationship; serve as the air traffic controller for 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, etc.) to enable stand-up and delivery transfers.
- Accountable for operational activities including:
- Compliance (Quality Risk Management, Deviation Management, Product Release, Change Control)
- Meeting Demand; dispute resolution (with escalation)
- Production Planning & Materials Management (system data entries, logistics)
- Technology issues
- Oversight of shop floor production and deploying ExM functional leads as needed
- Operational Excellence and Continuous Improvement
- End-to-end supply chain integration to optimize material flow
- Financial planning via participation in annual budget development
- Building and maintaining an interdependent relationship with site leadership (“read a site” to anticipate risks/opportunities)
- Issue escalation through a formal “Tier” process
- Partner with Procurement, Quality, Technology, and Supply Chain on commercial aspects across the relationship lifecycle (Identify, Select, Negotiate, Develop, Terminate)
- Develop an integrated view of external network capacity; escalate risk and guide mitigation
- Maintain Master Supply Agreement integrity and execution (aligned Supply/Quality agreements, document control; purchase orders, forecasts, deliveries, invoice payment approvals)
- Act as MPS leader/coach for Focus Factory Teams; identify and support operational excellence/CI opportunities with EP
- Drive Integrated Risk Management across the EP network (assessment, prioritization, mitigation)
- Contribute to External Manufacturing Network Strategy and drive strategic initiatives
- Plan strategically; understand EP business environment and opportunities/partners
- Drive boundaryless collaboration across internal stakeholders
- Lead special projects as needed

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

Qualifications / Required Experience
- Minimum 10 years’ experience in small molecule drug substance and/or drug product manufacturing (operations, quality, or technology)
- Compliance: experience achieving GMP and EHS compliance goals via risk-based approach (Drug Substance and/or Drug Product)
- Operational Excellence: proven Lean Six Sigma skills for compliant supply, highest quality, lowest cost, shortest lead-time
- Depth of manufacturing knowledge at management level for drug substance and drug product platforms
- New Product Introduction & Technical Transfer: proven record in planning/executing complex, multi-site technical transfers
- Demonstrated management/leadership experience
- Demonstrated experience managing a complex portfolio of projects

Preferred Experience
- Business & Financial acumen; ability to apply economic/financial/industry data to drive business value
- Accomplishment-oriented “business owner” mindset; influence without authority; ability to operate in ambiguous/changing environments
- Ability to prioritize conflicting demands, act with urgency, and follow up effectively
- Innovative thinking to experiment, learn, and adapt new ways of working

Enterprise Leadership Skills
- Influence; networking & partnerships
- Problem-solving/analytical skills in matrixed organizations; consensus building
- Strong communication with senior leadership and across all levels
- Collaborative approach with diverse stakeholders
- Strategic planning and action-oriented execution

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