Translate Product Lifecycle Team (PLT) decisions into executable work plans and coordinate implementation across the Lifecycle Management Execution team.
Ensure integrated project plans are developed, maintained and executed in alignment with agreed timelines and business priorities.
Monitor portfolio progress, proactively manage project risks and remove execution barriers.
Change Control Execution
Execution of Change Controls supporting Lifecycle Management activities in accordance with GMP, regulatory requirements and Amgen procedures.
Ensure Change Controls are planned, coordinated, implemented and closed within agreed timelines.
Coordinate execution across Manufacturing, Quality, Regulatory Affairs, Supply Chain, Planning and other impacted functions.
Monitor Change Control performance, compliance and milestone achievement.
Escalate critical risks, issues and delays, driving timely resolution with key stakeholders.
Ensure accurate project documentation, execution records and audit readiness.
Cross-Functional Collaboration
Partner with Product Lifecycle Teams (PLTs), Regional Operations Leads, Manufacturing Sites, Regulatory Affairs, Quality Assurance, Artwork & Labeling, Planning and Procurement organizations to ensure successful implementation of lifecycle initiatives.
Support implementation planning for complex lifecycle initiatives requiring coordination across multiple functions and geographies.
Build strong collaborative relationships across Regional and Site Operations to ensure successful execution.
Functional Skills
Must-Have Skills
Bachelor’s degree in supply chain management, Engineering, Life Sciences, Business or related discipline.
5+ years of experience in pharmaceutical Supply Chain, Manufacturing, Product Lifecycle Management, Regulatory Affairs or Project Management.
Strong knowledge of post-approval Lifecycle Management processes, CMC variations, labeling changes and Change Control execution.
Experience working in GMP-regulated pharmaceutical manufacturing environments.
Strong project management, stakeholder management and organizational leadership skills.
Excellent analytical, communication and problem-solving capabilities.
Good-to-Have Skills
Experience working within Product Lifecycle Teams (PLTs).
Knowledge of pharmaceutical commercialization processes.
Experience with SAP, project portfolio management tools and Smartsheet/MS Project.
Lean, Six Sigma or Operational Excellence experience.
Project Management certification (PMP, PRINCE2 or equivalent).
Professional Certifications
Preferred
Master’s degree in supply chain management, Engineering, Business, or related field.
PMP, PRINCE2 or equivalent Project Management certification.
Lean Six Sigma Green Belt or equivalent Operational Excellence certification.
Soft Skills
Strong verbal and written communication skills.
Strong planning, prioritization and organizational skills.
Ability to lead multiple priorities in a fast-paced environment.
High degree of initiative, accountability and ownership.
Strong analytical and decision-making capabilities.
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
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