Specialist IS Business System Analyst

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

Key responsibilities of the Systems Analyst include:

• Actively engages with business users to analyze business needs, gather and document business and solution requirements guided by best practices in Holistic Lab, Instrument Data Acquisition, and Business Reporting requirements against the Enterprise Data Lake
• Works with cross-functional representatives across all Process Development functions and sites to align Product Development processes with Holistic Lab and IS4PD technology capabilities
• Works across business organizations to create and maintain an integrated Holistic Lab approach to process development, manufacturing, and quality
• Collaborates with IS Architects and System Owners to design an integrated solution across HL, Enterprise Data Lake (EDL), Product Lifecycle Management (PLM), and lab instrument solutions
• Provides guidance to project teams on defining business needs, articulating solutions and approaches for addressing business needs, and presenting business cases for proposed solutions
• Oversees a team of contractors and provides guidance as necessary to ensure the delivery of defined work
• Works with the integration solution architects and designers to design integrated solutions across systems within the company environment - e.g. data flows. 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.

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:

• Familiarity with Electronic Lab Notebook and Data Lake in the biotech and pharmaceutical industries is preferable
• Solid depth or breadth of expertise with offerings within the Lab solution landscape - including BIOVIA's Workbook, 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, 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
• Experience with globally distributed applications
• Knowledge of Software Architecture 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 effectively in an environment of ambiguity
• Strong team player who is able to collaborate with colleagues on complex tasks and can provide leadership through influence to achieve the required results
• Additional requirements include solid project management skills, excellent analytical and problem-solving skills, ability to execute multiple concurrent work streams, ability to work in cross-functional teams, and experience with formal project methodologies.