Director, External Manufacturing Operations

Our Company's Global Pharmaceutical Operations (GPO) External Manufacturing organization manages 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 converts our pipeline to products through commercialization activities at CMOs for Drug Substance and Drug Products. The Platform also accelerates regionalization strategies and ensures CMOs manufacturing our acquired assets are integrated into our external network, covering strategic sourcing and technical transfer from pre‑PPQ through post‑launch builds.

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• The candidate leads an organization with direct oversight of the relationship with the CMO, acting as the air traffic controller of all information and interactions between the Company and the CMO, establishing boundaries and rules of engagement, and issuing escalations.
  
• Represents External Manufacturing operations on cross‑functional teams with Development & Commercialization Teams, Value Chain Management, Science & Technology, Procurement, and others to enable stand‑up and delivery of pipeline transfers.
  
• Accountable for all operational activities: compliance, demand meeting, dispute resolution, production planning, technology issues, shop floor oversight, operational excellence, supply chain optimization, financial planning, and partnership building with EP site leadership.
  
• Steers issue escalation through a formal tier process and partners with Procurement, Quality, Technology, and Supply Chain on commercial aspects throughout the relationship lifecycle.
  
• Develops an integrated view of capacity across the external partner network, escalates risk, and guides execution of mitigation actions.
  
• Maintains integrity of the Master Supply Agreements, ensuring alignment with Supply and Quality agreements and executing contractual terms such as purchase orders, forecasts, deliveries, and invoice payments.
  
• Leads as the company's Production System (MPS) leader and coach for internal Focus Factory Teams, supporting continuous improvement opportunities.
  
• Drives the development of an Integrated Risk Management program across the EP network.
  
• Contributes to the External Manufacturing Network Strategy and other strategic initiatives.
  
• Plans strategically and understands the EP business environment and partner opportunities.
  
• Leads boundaryless collaboration, influencing key stakeholders across all levels of management.
  
• Leads special projects and assignments as needed.
  

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• Bachelor’s degree minimum in Engineering or Science (preferred).
  
• Minimum ten (10) years of experience in small molecule drug substance and/or drug product manufacturing (operations, quality, or technology).
  

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• Compliance: ability to achieve GMP and EHS compliance goals using a risk‑based approach across drug substance and/or drug product.
  
• Operational Excellence: proven Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost, and shortest lead‑time.
  
• Depth of Manufacturing Knowledge: proven expertise at the management level of drug substance and drug product platforms.
  
• New Product Introduction & Technical Transfer: proven record in planning and executing complex, multi‑site technical transfers.
  
• Management/leadership experience and ability to manage a complex portfolio of projects.
  

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• Business & Financial Acumen: ability to apply economic, financial, and industry data to business decisions.
  
• Self‑motivated, accomplishment oriented, with a “business owner” mentality and the ability to influence without authority.
  
• Ability to work in ambiguous situations, prioritize demands, act with urgency, and follow up effectively.
  
• Innovative thinking to experiment, learn, and adapt new ways of working and initiatives supporting the strategy.
  

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• Influence: effective persuasion strategies to gain acceptance of ideas and commitment to actions.
  
• Networking & Partnerships: building partnerships and leveraging relationships internally and externally.
  
• Problem‑solving and analytical skills, navigating matrixed organizations, building consensus, and influencing decisions.
  
• Strong communication skills to engage senior management and across all levels.
  
• Collaborative nature to work with diverse personalities and stakeholders.
  
• Strategic Planning: prioritizing, planning, and establishing action plans with timelines and resources.
  

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• 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
  

Effective September 5, 2023, employees in office‑based positions in the U.S. will work a hybrid model consisting of three total days on‑site per week (Monday – Thursday, with Friday designated as a remote‑working day) unless business‑critical tasks require an on‑site presence. This model does not apply to field‑based, facility‑based manufacturing, research, or remote‑designated positions.

$173,200.00 – $272,600.00

We offer a comprehensive package of benefits including medical, dental, vision, and other insurance for employees and families, retirement benefits with 401(k) plans, paid holidays, vacation, compassionate and sick days. More information about benefits is available at Employment Opportunity

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. xcfaprz

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