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.

Let’s do this. Let’s change the world. In this vital role you will support the Process Development organization with a focus on Digital Lab Program. This individual will contribute to the success of DTI functions by making fundamental improvements in how information is managed, business processes are operated, physical processes are controlled, and workflow is directed. The Analyst will efficiently achieve the integration and orchestration of all activities required for product development and will participate in strategic multi-functional meetings to facilitate the optimization of processes through implementation of solutions that enable enterprise-wide information knowledge management.

• Actively engages with business users to analyze business needs, gather and document business and solution requirements guided by standard methodologies in Holistic Lab, Instrument Data Acquisition, and Business Reporting requirements against the Enterprise Data Lake
• Works with multi-functional representatives across all Process Development functions and sites to align Product Development processes with Holistic Lab and integrated 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 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 work throughout development to ensure quality and traceability to requirements and consistency to all quality management plans and standards. Participate in quality management reviews.
• Ability to work with and drive Agile project methodology

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

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 teammate who can collaborate with colleagues on complex tasks and can provide leadership through influence to achieve the required results
• 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
• Solid depth or breadth of expertise with BIOVIA's Workbook, ULM (Unified Lab Management), CISPro, Compose and Pipeline Pilot OR similar experiment management solutions
• Understanding of computer system validation & SDLC in biotech manufacturing and laboratory areas
• Ability to translate the business needs into use cases/process flows
• Knowledge of Software Architecture and the structure of software solutions
• Ability to master, with minimal support, new IS technologies and processes (from end user to system admin)
• 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
• Additional requirements include accountability/ownership of tasks/projects, project management skills, excellent analytical and problem-solving skills, ability to implement multiple concurrent work streams, ability to work in multi-functional teams
• Experience with Agile project methodologies (experience as scrum master preferred).