Amgen Specialist IS Business Systems Analyst in Thousand Oaks, California

Amgen (NASDAQ:AMGN), 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. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients.

The Specialist IS Business Systems Analyst works within the Operations IS (OIS) group to support the Process Development business organization with a focus on Product Lifecycle Management. The successful candidate will contribute to the success of Operations IS functions by making fundamental improvements in how information is managed, business processes are operated, physical processes are controlled, and work flow is directed to efficiently achieve the integration and orchestration of all activities required for product development. He or she will attend strategic cross-functional meetings to facilitate the optimization of processes through implementation of solutions that enable enterprise-wide information knowledge management.

Responsibilities

Primary:

  • Actively engage with business users to analyze business needs, gather and document business and solution requirements guided by best practices in PLM.

  • Work with cross-functional representatives from Device Engineering, Process Development, Quality Compliance, and Clinical Operations to define and align Product Development processes with PLM technology capabilities

  • Work across business organizations to create and maintain an integrated PLM approach to process development, manufacturing, and quality

  • Collaborate with IS Architects and System Owners to design an integrated solution across PLM, ERP, document management, and lab execution systems

  • Provide guidance to project teams on defining business needs, articulating solutions and approaches for addressing business needs, and presenting business cases for proposed solutions.

  • Work with the integration solution architects and designers to design integrated solutions across systems within the company environment - e.g. data flows. Work with project teams to ensure all data requirements, migrations and standards are clearly understood and implemented.

  • Review project deliverables throughout development to ensure quality and traceability to requirements and adherence to all quality management plans and standards. Participate in quality management reviews.

  • Manage the backlog of requirements/user stories and oversee PLM configuration specifications

Secondary

  • Assist technical and solution architects in ensuring system designs fulfill requirements, perform to defined standards, and scale appropriately to meet business growth

  • Identify and develop solutions that meet business needs

  • Perform system configurations and light customizations via Process Extensions (PX)

  • Develop project plans, identify resource needs, and understand how to execute IS projects according to time and budget commitments

  • Work with architects and other business analysts to ensure that all components work together to meet objectives and performance goals as defined in the requirements.

  • Identify and communicate any cross-area or cross-release issues that may affect other areas of the project.

  • Support application development and test teams

Basic Qualifications:

Doctorate Degree

OR

Master's Degree AND 3 years of Information Systems experience

OR

Bachelor's Degree AND 5 years of Information Systems experience

OR

Associate's degree AND 10 years of Information Systems experience

OR

High school diploma/GED AND 12 years of Information Systems experience

Preferred Qualifications:

  • Solid understanding of PLM architecture and configuration, including: interfaces, item libraries, engineering change orders (ECOs), Bills of Materials (BOM) management, and lifecycle states.

  • Familiarity with Product Lifecycle Management practices in the biotech and pharmaceutical industries is preferable; experience with the composition and assembly of filing submissions within the Bio-Pharma lifecycle a plus

  • Solid depth or breadth of expertise with offerings within the PLM solution landscape - including Oracle Agile

  • Experience working with Big Data integration and Analytics a plus

  • Good overall understanding of business, manufacturing, and laboratory systems common in the pharmaceutical industry, as well as the integration of these systems through applicable standards.

  • Understanding of FDA regulations governing computer system validation and operation in biotech manufacturing and laboratory areas.

  • Ability to translate the enterprise's aspirations for information sharing into the reality of detailed actions in the laboratory, quality, engineering, manufacturing, and IS organizations, including an understanding of data modeling, data quality, data management strategy to support business needs, data access methods, and approaches and experience in data access systems for use in the pharmaceutical industry.

  • Excellent verbal, written, and interpersonal communication skills, including the ability to set the context and present on complex subjects to senior management in a clear and concise manner.

  • Experience building productive working relationships with business clients

  • Strong leadership, project management skills.

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.