Project Manager, CMC Integration

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. 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, CMC Integration

What you will do

Let’s do this. Let’s change the world. Amgen is searching for a Project Manager in our Global Operations Planning & CMC Integration team. This role will report to a Sr. Project Manager in CMC Life Cycle Management (LCM), in Process Development. The Project Manager (PM) will be responsible for integrating Process Development (PD) activities by developing and maintaining project timeline for Amgen pipeline projects. This Project Manager will have a significant focus on supporting programs in the pivotal (late stage) phase. Working with the Global Operations Leader and other members of the Product Delivery Team, the PM develops and aligns plans and schedules for PD activities with business priorities. The PM captures associated project risks, develops mitigation plans and communicates project status clearly to impacted collaborators. The PM assists with driving decision making for the project and ensures that action items are captured and tracked to completion. The PM partners with PD technical leads to identify key deliverables and activities to be completed, identifies dependencies, and optimizes the sequence of project activities. The PM ensures cross-functional alignment through the integration of interdependent activities and through the communication of plans and timelines, with specific emphasis on critical path activities. The PM assists PD technical leads with tracking the execution of required deliverables and assists with navigating project teams through corporate governance. The PM collects, digests and assembles information to enable relevant business analysis and influence decision-making. The PM will demonstrate soft skills, technical knowledge, and leadership attributes to influence positive project outcomes.

Responsibilities include but are not limited to:

• Work with technical and/or Product Delivery Teams by creating project timeline that align with PD prioritization

• Support projects that apply internal and external personnel, contract firms, and partners

• Assist PD in driving decision making using DAI principles (D- Decision maker, A- Advice Giver, I- Informed) by producing risk analyses and scenario planning

• Ensure participation in functional and cross-functional management reviews

• Establish and manage collaboration and team SharePoint sites

• Provide meeting management support including meeting planning, scheduling, facilitation, documentation (development of meeting agenda and minutes), and outcomes communication

• Ensure product project reporting to Product Lifecycle Management (PLM)

• Manage and prioritize support of multiple project teams at one time

• Facilitate and incorporate lessons learned, standard methodologies, etc.

• Support business process improvements

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• Doctorate Degree OR

• Master's Degree & 2 years of Project Management or Operations experience OR

• Bachelor's Degree & 4 years of Project Management or Operations experience OR

• Associate's degree & 8 years of Project Management or Operations experience OR

• High school diploma/GED & 10 years of Project Management or Operations experience

Preferred Qualifications:

• 10+ years of experience in the Pharmaceutical, Biotechnology or other Healthcare-related field

• Direct CMC experience

• Experience in an environment requiring one to foster collaboration and work effecti