This senior individual contributor role within the Manufacturing Support organization provides technical leadership and operational support for safe, compliant, and efficient manufacturing training operations across the site. The specialist ensures manufacturing workforce readiness and startup readiness outcomes, serving as a site subject matter expert for manufacturing training processes, training effectiveness, and continuous improvement programs. The position requires significant floor presence and broad partnership with various teams in a 24/7 manufacturing environment.
Responsibilities
Develop and execute the manufacturing training strategy for ANC-1 and ANC-2, ensuring alignment with business objectives, operational readiness requirements, compliance expectations, and workforce capability needs
Create, implement, and continuously mature the Training Assignment Portfolio (TAP) for ANC-1 and ANC-2 to establish role-based qualification pathways, own qualification planning and execution, improve training effectiveness, and support sustainable operational performance
Develop and maintain training and workforce readiness governance tools, metrics, and reporting processes to monitor training compliance, qualification status, staffing readiness, procedural readiness, and overall manufacturing startup readiness
Identify readiness risks and gaps through metric review, stakeholder input, and floor engagement, then drive mitigation actions to protect operational readiness milestones, engineering runs, validation execution, and startup commitments
Escalate and resolve issues when training, qualification, staffing, procedures, or other manufacturing readiness deliverables threaten startup milestones or operational readiness commitments
Strengthen alignment between hiring plans, qualification plans, readiness milestones, engineering runs, and validation execution to ensure the manufacturing workforce is prepared to support ANC-2 startup and routine operations
Lead Manufacturing Fundamentals Training programs to support onboarding and qualification of new hires within the ANC-1 and ANC-2 organizations, ensuring consistent foundational knowledge and accelerated readiness
Serve as the training lead for the 2027 Learning Management System (LMS) migration, partnering with cross-functional stakeholders to support planning, implementation, change management, training impact assessments, and successful adoption of the new platform
Lead training improvement initiatives across manufacturing operations
Own and implement training-related corrective and preventive actions (CAPAs), ensuring timely execution, effectiveness monitoring, and sustained compliance
Assess training effectiveness and identify opportunities to strengthen workforce capability, procedural adherence, and operational performance
Develop and deliver technical training programs, including the Wake Tech Customized Training Program, to improve employee knowledge, capability, and performance
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Coach manufacturing personnel and frontline leaders on GMP compliance, operational excellence practices, and manufacturing best practices
Partner with Manufacturing, Quality, Engineering, and Continuous Improvement teams to establish and maintain training curricula that support process changes, operational excellence initiatives, and inspection readiness
Maintain a strong presence on the manufacturing floor to provide training support, coaching, and technical assistance to frontline teams and leaders
Serve as a subject matter expert for LMS and training-related processes in manufacturing
Partner with operations teams to identify and implement training improvements that enhance safety, quality, delivery, and productivity
Drive right-first-time execution through Human and Organizational Performance (HOP) tools and collection of operator feedback
Partner effectively with Quality, Engineering, Validation, Supply Chain, HR, and Manufacturing teams to achieve site objectives and maintain integrated readiness plans that connect staffing, training, qualification, procedure readiness, engineering runs, and validation activities
Influence stakeholders at multiple organizational levels to drive alignment, resolve issues, and implement sustainable solutions
Serve as a key Manufacturing representative within ANC-2 Operational Readiness governance and planning activities, ensuring manufacturing workforce readiness, qualification execution, and startup risks are visible, aligned, and actively managed
Provide data-driven recommendations, readiness metric insights, and risk-based mitigation options to support business decisions, issue resolution, and operational readiness governance
Requirements
Doctorate degree
Master’s degree in chemistry, biology, or engineering & 3 years of biotechnology operations experience
Bachelor’s degree and 5 years of biotechnology operations experience
Associate’s degree & 10 years of biotechnology operations experience
High school diploma / GED & 12 years of biotechnology operations experience
Nice to have:
Hands on experience facilitating problem solving in a biotechnology environment
Experience with training development and facilitation
Experience owning and editing standard operating procedures
Familiarity with the deviation management systems and corrective/preventative actions
Project management skills with ability to multi-task and function in a dynamic environment
Excellent communication skills and sense of urgency
Demonstrated ability to forge and maintain strong relationships
Strong knowledge of Learning Management Systems (LMS)
About the Company
Amgen is one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Its newest and most advanced drug substance manufacturing plant, the FleX Batch facility, will combine disposable technologies with traditional stainless-steel equipment for maximum flexibility. The facility will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
