This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
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