Amgen Project Mgr, CMCi 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:

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

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

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

*Follow Amgen's governance processes, procedures, specifications, and applicable compliance standards and guidance documents

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

*Use project controls to track project progress, keep the team informed and organized (e.g. project schedule, action items log, decision log, risk log, etc.)

*20% travel domestic and international

Basic Qualifications

Doctorate degree

OR

Master's degree and 2 years of Project Management or Operations or Process Development experience

OR

Bachelor's degree and 4 years of Project Management or Operations or Process Development experience

OR

Associate's degree and 10 years of Project Management or Operations or Process Development experience

OR

High school diploma / GED and 12 years of Project Management or Operations or Process Development experience

Preferred Qualifications

-PMP Certification

-5 years+ of project management experience in the Pharmaceutical, Biotechnology or direct CMC or PD PM experience

  • Deep understanding of Biologic and/or Synthetic Drug Substance/Drug Product development processes over the product life cycle, from pivotal to product launch including process characterization, product characterization and commercial tech transfer

  • Must be able to support any type of project, irrespective of phase or complexity

-Experience with a manufacturing developmental partner (e.g. CMO)

-Experience using Project Management Tools, methodologies, practices and infrastructure, as related to the Biopharmaceutical Industry

-Drug Substance/Drug Product development knowledge with basic to strong understanding of other functions relevant to the position which may include: Regulatory, Quality, Human Factors, Manufacturing, Packaging, Supply Chain, and Commercial

-Ability to provide leadership in a highly fluid, interactive, matrix environment resulting in the advancement of complex projects to completion

-Ability to understand projects at the tactical level while maintaining the overall project strategy and priorities aligned

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.