Project Manager, Operational Readiness

Amgen Inc. (IR)

Holly Springs (NC)

On-site

USD 110,000 - 148,000

Full time

3 days ago
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Benefits offered by this job

Retirement and Savings Plan
Annual bonus program
Stock-based long-term incentives
Flexible time-off plans

Job summary

Amgen Inc. (IR) is seeking a Project Manager, Operational Readiness to plan, coordinate, and execute readiness activities across manufacturing, engineering, quality, supply chain and more.

You will develop schedules, risk logs, and milestone tracking, ensuring a smooth turnover to routine operations and successful regulatory readiness. The role requires strong facilitation, communication, and stakeholder management skills, with experience in regulated pharma/biotech settings and familiarity with

Qualifications

  • Experience planning, coordinating, and executing Operational Readiness within regulated environments.
  • Formal education in project management or related fields as listed above.
  • PMP or equivalent certification preferred.

Responsibilities

  • Plan, coordinate, and execute Operational Readiness activities across multiple workstreams.
  • Develop readiness plans, schedules, action trackers, risk logs and milestone tracking.
  • Capture lessons learned and implement improvements to tools and processes.
  • Coordinate inspection readiness activities and startup stabilization.

Education

High school diploma / GED
Associate’s degree
Bachelor’s degree
Master’s degree
Doctorate degree

Tools

Project Planning Tools
Microsoft Project
Smartsheet
Excel
Microsoft Teams

Job description

Career Category Project Management Job Description 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. 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The high-performing professional we seek is an effective facilitator with strong cross-functional project management and communication skills with these qualifications.

Basic Qualifications
  • 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
Preferred Qualifications
  • 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.
What you can expect of us

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

  • 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

Refer to the Work Location Type in the job posting to see if this applies.

Sponsorship

Sponsorship for this role is not guaranteed.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided 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. Please contact us to request accommodation.

Your application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Salary Range 109,640.65USD -148,337.35 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

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