Amgen Project Manager - Process Development in Thousand Oaks, California

Reporting into the Program Management Office within the Process Development Late-Stage and Life Cycle Management (LCM) organization, this role will support cross-functional teams from multiple Amgen sites, functions and external partners, to develop innovative drug products and/or drug/device combination products.

The Project Manager (PM) is responsible for integrated Process Development (PD) activities by developing and maintaining technical project plans and schedules for late-stage and lifecycle projects which may include commercial PD activities, clinical manufacturing, analytical development, commercial process development, process characterization and validation, new formulations, new manufacturing processes, process and technology transfers and new or platform drug delivery devices. 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 stakeholders. 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 is expected to have authoritative command with complexity and ambiguity, and is expected to have the ability to collect, digest and assemble information in order to enable relevant business analysis and influence decision-making. The PM is expected to leverage soft skills, technical knowledge, and leadership attributes in order to influence positive project outcomes.

Responsibilities include but are not limited to:

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

  • Support combination product development programs utilizing structured, systematic methodologies to meet cost and schedule objectives

  • Follow Amgen's governance processes, procedures, specifications, design controls, and applicable compliance standards and guidance documents

  • Integrate PD activities by developing and maintaining detailed project schedules for Amgen pipeline, inline, and biosimilar projects

  • Partner with PD functional leads to identify key deliverables and ensure cross functional alignment and accountability

  • Negotiate and resolve conflicts and drive decisions among team/functional members to accomplish project and business goals

  • Assist the PD Organization in driving decisions by using the Decision Making Framework (D- Decision maker, A- Advice Giver, I- Informed)

  • Ensure participation in functional and cross-functional management reviews

  • Establish and manage collaboration and team sites (e.g. SharePoint)

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

  • Provide meeting facilitation, including development of meeting agenda and minutes

  • Accurately capture and monitoring status of action items through effective tracking tools and communication of progress

  • Track delivery and create repositories for all PD deliverables

  • Facilitate and incorporate lessons learned, best practices, etc.

  • Project reporting including appropriate risk analysis

  • 20% travel domestic and international

Basic Qualifications

Doctorate degree

OR

Master's degree and 2 years of Project Management experience

OR

Bachelor's degree and 4 years of Project Management experience

OR

Associate's degree and 10 years of Project Management experience

OR

High school diploma / GED and 12 years of Project Management experience

Preferred Qualifications

PMP Certification

5 years+ of project management experience in the Pharmaceutical, Biotechnology or other Healthcare-related field, direct CMC or PD PM experience.

Experience successfully developing and launching commercially viable pharmaceutical or combination drug/device products from concept to commercialization.

Deep understanding of and experience with disciplined product development processes (phase/gate product development method).

Experience developing products that are manufactured at high volumes using automated and semi-automated manufacturing processes.

Ability to foster collaboration, work effectively on cross-functional teams, and consistently deliver on-time.

Experienced in creating and maintaining a Design History File.

Strong oral and written communication skills; strong interpersonal skills; demonstrated time management and decision-making skills.

Experience with performing critical path analysis.

Critical thinking and problem-solving skills.

Quick learner, proactive, takes initiative.

Distinguishes proper balance between strategic and tactical thinking.

Strong experience with Project Management tools, methodologies, and practices.

Proven ability to manage in a highly fluid, interactive, matrix environment.

Experience with MS Office, Project, Excel and SharePoint.

Ability to drive prioritization based on business drivers and technical/regulatory risk.

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 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.

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, or disability status.

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, or disability status.