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Director, Manufacturing Execution

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Amgen

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Location:
United States , Holly Springs

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Category:

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Contract Type:
Not provided

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Salary:

190965.00 - 225559.00 USD / Year

Job Description:

In this vital role you will be accountable for leading all drug substance manufacturing execution activities within our site’s second FleX Batch manufacturing facility. This role provides end-to-end operational leadership across Upstream Cell Culture, Downstream Purification, and Services (media and buffer preparation), ensuring safe, compliant, reliable, and cost-effective production of biologic drug substance. The leader will build and lead a high-performing organization responsible for 24/7 manufacturing operations, delivering against safety, quality, supply, cost, and people objectives while fostering a culture of execution excellence, accountability, and continuous improvement.

Job Responsibility:

  • Provide strategic and operational leadership for all execution activities across Upstream, Downstream, and Services operations within the FleX Batch facility
  • Ensure safe, compliant, and reliable manufacturing of drug substance in accordance with cGMPs, regulatory commitments, and Amgen Quality standards
  • Own performance across key operational metrics including Safety, Quality (RFT, deviations, CAPA effectiveness), Delivery (schedule adherence, campaign execution), Cost, and People
  • Ensure robust daily management systems are in place to monitor performance, identify gaps, and drive timely escalation and resolution
  • Partner cross-functionally with Process Development, Manufacturing Support, Quality, Supply Chain, Engineering, Maintenance, and Digital to ensure seamless execution of production campaigns
  • Drive a culture of disciplined execution and continuous improvement
  • Champion right-first-time performance and reduction of deviations, human performance errors, and process variability
  • Leverage Industry 4.0 digital tools, automation, and data analytics to enhance process robustness and decision-making
  • Support facility start-up, technology transfers, validation activities, and lifecycle management of products manufactured within the FleX Batch facility
  • Ensure operational readiness for new product introductions, capacity expansions, and process improvements
  • Drive standardization and harmonization of execution practices across manufacturing areas
  • Build and develop a diverse, engaged, and high-performing leadership team, including Senior Managers and frontline leaders across all execution areas
  • Establish a culture of safety, accountability, collaboration, and inclusion
  • Develop organizational capability, succession pipelines, and leadership bench strength
  • Model Amgen Values and leadership behaviors
  • create an environment of trust, transparency, and empowerment
  • Ensure effective labor and resource planning to support current and future manufacturing demands
  • Serve as a key member of the site Manufacturing Leadership Team
  • Collaborate with Global Manufacturing and other Amgen sites to share best practices and align on network standards
  • Represent Manufacturing during regulatory inspections, internal audits, and leadership reviews
  • Engage with senior site and global stakeholders to ensure alignment on priorities, risks, and mitigation plans

Requirements:

  • Doctorate degree and 4 years of manufacturing experience
  • Master’s degree and 8 years of manufacturing experience
  • Bachelor’s degree and 10 years of manufacturing experience
  • 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Nice to have:

  • Currently in a leadership position in a GMP manufacturing plant
  • Experience in biologics drug substance manufacturing, including cell culture and purification operations
  • Demonstrated leadership of large-scale GMP manufacturing organizations in a 24/7 environment
  • 6 years managing a team, leading and managing operations
  • Proven ability to drive operational excellence and continuous improvement initiatives
  • Experience leveraging digital manufacturing systems (MES, automation platforms, data analytics tools)
  • Demonstrated ability to influence across functions and levels of the organization
  • Excellent communication and negotiation skills including executive level communication, and the ability to engage frontline staff through executive leadership
  • Experience in a matrixed, cross-site or global network environments
What we offer:
  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible

Additional Information:

Job Posted:
March 20, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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