Project Manager, Operational Readiness

Amgen•Holly Springs, NC

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. PROJECT MANAGER, OPERATIONAL READINESS What you will do Let’s do this. Let’s change the world. In this vital role you will plan, coordinate, and execute Operational Readiness activities, ensuring the organization is prepared to safely and compliantly deliver our startup, new product introduction, performance qualification, inspection readiness, and the transition to routine operations. You will directly support Manufacturing, Engineering, Quality, Supply Chain, Process Development, and Digital workstreams and work closely with Construction and Commissioning & Qualification teams to align readiness activities with project milestones.

Requirements

  • High school diploma / GED and 10 years of Project Management experience
  • Associate’s degree and 8 years of Project Management experience
  • Bachelor’s degree and 4 years of Project Management experience
  • Master’s degree and 2 years of Project Management experience
  • Doctorate degree

Nice To Haves

  • Experience planning, coordinating, and executing Operational Readiness, startup, inspection readiness, or operational transition activities within a regulated pharmaceutical or biotechnology environment.
  • Working knowledge of facility turnover, commissioning, qualification, validation, startup, and operational handover processes.
  • Experience coordinating cross-functional teams and delivering complex readiness activities without direct authority.
  • Strong project planning, scheduling, organization, risk management, and issue-resolution skills.
  • Demonstrated ability to manage multiple priorities and deliver results in a fast-paced project environment.
  • Strong facilitation, communication, and stakeholder management skills.
  • Proficiency with project planning and collaboration tools such as Microsoft Project, Smartsheet, Excel, and Microsoft Teams.
  • PMP certification or an equivalent project management credential preferred.

Responsibilities

  • Facilitate scope development, planning, coordination, and execution of Operational Readiness and new product introduction activities across multiple workstreams.
  • Develop and maintain readiness plans, schedules, action trackers, risk logs, and milestone tracking across functional workstreams.
  • Define and track readiness requirements across personnel, training, procedures, systems, materials, and operational processes.
  • Coordinate cross-functional readiness activities, monitor progress, identify gaps, and drive timely completion of deliverables.
  • Facilitate readiness workshops, planning sessions, and working meetings to align stakeholders and address execution issues.
  • Partner with Construction and Commissioning & Qualification teams to understand project milestones, turnover plans, and startup timelines, ensuring Operational Readiness activities remain aligned with facility delivery schedules.
  • Track Operational Readiness dependencies, risks, constraints, and mitigation actions associated with project delivery and communicate readiness status to project teams and site leadership.
  • Coordinate inspection readiness activities, including readiness assessments, action tracking, gap remediation, and support for regulatory inspections.
  • Coordinate operational handover and startup stabilization activities to support a successful transition to routine operations.
  • Capture lessons learned and implement improvements to Operational Readiness tools, processes, and execution practices.

Benefits

  • A 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
  • Flexible work models where possible.
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