Amgen is seeking a Senior Associate Information Systems Business Systems Analyst. This role within Operations IS (OIS) group will support the Process Development organization with a focus on Digital Lab Program. Holistic Lab is a groundbreaking platform driving fundamental improvements in how information is collected, run and analyzed while structuring process execution for digital transformation. You will serve as key member of the platform team and collaborate with business partners to deliver the digital lab roadmap for Operations.
+ The role will be part of the Holistic Lab systems team responsible for delivering coordinated digital solutions in support of Process Development
+ Assemble, analyze, and represent business requirements through active partnerships
+ Serve on the Product Team and drive user story definition, features, and functions required to deliver against business outcomes. Acts as Scrum Master and supports Agile development processes
+ Provides mentorship to project teams on defining business needs, articulating solutions and approaches for addressing business needs, and presenting business cases for proposed solutions
+ Drive testing and validation in a GxP environment including validation protocols such as Requirements and Design Specifications, Installation and Operational Qualification documents, as well as testing and UAT
+ Assist run support teams and serve as point of contact for critical issues
+ Maintain and build relationships with key business partners
+ Raise as appropriate problems and issues to management
+ Participate in proactive state of the art research with current technologies and provide recommendations for continuous improvement
Bachelor’s degree plus 2 years of information systems experience
Associate’s degree plus 6 years of information systems experience
High school diploma / GED and 8 years of information systems experience
+ Familiarity with Electronic Lab Notebook and Data Lake in the biotech and pharmaceutical industries is preferred
+ Depth or breadth of expertise with offerings within the Lab solution landscape – including BIOVIA’s Workbook, ULM, CISPro, Compose and Pipeline Pilot
+ 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
+ Knowledge or experience with design and deployment of globally distributed applications
+ Knowledge of Software Architecture principles and the structure of software solutions
+ Ability to master, with minimal support, new IS technologies and processes
+ Effective written and verbal communication skills
+ Able to multi-task and stay focused on priorities in a fast-paced environment to meet deadlines, including the ability to be comfortable and function efficiently in an environment of ambiguity
+ Someone who can be an excellent teammate, able to collaborate with colleagues on complex tasks and can provide leadership through influence to achieve the required results
+ Additional requirements include proven project management skills, excellent analytical and problem-solving skills, ability to execute multiple concurrent work streams, ability to work in multi-functional teams, and experience with formal project methodologies
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 uses 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. The Research organization is the innovation engine discovering and developing next generation of innovative medicines to meet unmet medical needs.
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.