Amgen Project Manager - Process Development in Thousand Oaks, California
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 will collect, digest and assemble information in order to enable relevant business analysis and influence decision-making. The PM will leverage soft skills, technical knowledge, and leadership attributes in order to influence positive project outcomes.
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.
Responsibilities of the Project Manager include:
Support projects that utilize internal and external personnel, contract firms, and partners
Support Drug Substance, drug product, and combination product development programs utilizing structured, systematic methodologies to meet cost and schedule objectives
Develop and manage PD activities in an integrative fashion via detailed project schedules for Amgen pipeline, inline, and biosimilar projects encompassing cross-functional scope of work
Partner with PD functional leads to identify key deliverables and ensure cross functional alignment and accountability
Drive negotiation, decision making, and conflict resolution 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)
Establish and manage collaboration and team sites (e.g. SharePoint)
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
Project reporting including appropriate risk analysis
Up to 20% travel domestically and internationally
Basic Qualifications :
Master’s degree and 3 years of Project Management, Process Development or Operations experience
Bachelor’s degree and 5 years of Project Management, Process Development or Operations experience
Associate’s degree and 10 years of Project Management, Process Development or Operations experience
High school diploma / GED and 12 years of Project Management, Process Development or Operations experience
5+ years of project management experience in the Pharmaceutical, Biotechnology or other Healthcare-related field, direct CMC or PD PM experience
Understanding of and experience with product development processes
Ability to foster collaboration, work effectively on cross-functional teams, and consistently deliver on-time
Strong oral and written communication skills; strong interpersonal skills; demonstrated time management and decision-making skills
Proven ability to manage in a highly fluid, interactive, matrix environment
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.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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.