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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Senior Manager IS - Process Development Lab Systems

Live

What you will do

Let’s do this. Let’s change the world. Operations Digital, Technology, and Innovation (OPS DTI) is accountable for the delivery of the information and Operations technology systems that enable the successful development, design, manufacturing, distribution and commercialization of Amgen products. Holistic Lab is a groundbreaking platform that is driving fundamental improvements in how information is collected, managed, and analyzed while structuring process execution for digital transformation. This key role within OPS DTI will serve as Technical Product Owner (TPO) of the Lab Systems Product Team. You will lead in the space of digital platforms, making an impact with strategy and roadmap development, as well as flawless execution. You will be a key member of the Leadership Team, driving the success of the organization as it transforms the technical landscape through digital initiatives.

In this role you will lead the technical delivery for this capability as part of a team of scientists and engineers. The team will rely on your leadership to own and refine the vision, feature prioritization, partner alignment, and experience leading solution delivery while building this ground-breaking new capability for Amgen. The Technical Product Lead understands both the engineering and customer side of the product release. You will collaborate with strategic partners to define and deliver the digital lab roadmap for Operations and support next generation lab processes including simulations, machine learning and knowledge management. You will own the long-term technology strategy and be accountable for management and support of current and new lab information management systems including ELN and Chromatography Data Systems. This position can be based in Thousand Oaks, California, but we are open to Remote candidates anywhere in the United States, as long as they are willing to travel up to 10%.

Specific Responsibilities:

Own, manage, and support Lab Systems Portfolio including:

• Overall product and product features from concept to end of life
• Management of the product team to ensure that business, quality, and functional goals are met with each product release
• Develop and prioritize features and stories ensure work focuses on those with maximum value that are aligned with product strategy
• Plan releases and upgrades
• Inspire and motivate the product team to deliver innovative and exciting solutions with an appropriate sense of urgency
• Develop lab systems roadmap for Amgen Operations; accounting for current and future business needs and make technology decisions. Collaborate with IS Architects, Infrastructure Leads and Business Analysts to develop roadmaps supporting organizational priorities and platform improvements
• Work with multi-functional representatives across Process Development and sites to align business processes with Holistic Lab, PLM and Big Data technology capabilities
• Lead vendors and contractors providing guidance as necessary to ensure the delivery of work
• Lead key strategic supplier relationships from both product and services side, as required.
• Ensure compliance with Amgen and industry practices policies, procedures, legal requirements and goals of project sponsors

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Product Owner professional we seek is a self-started with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Information Systems and Software Engineering experience

Or

Master’s degree and 4 years of Information Systems and Software Engineering experience

Or

Bachelor’s degree and 6 years of Information Systems and Software Engineering experience

Or

Associate’s degree and 10 years of Information Systems and Software Engineering experience

Or

High school diploma / GED and 12 years of Information Systems and Software Engineering experience

And

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

• 8+ years of biopharma experience with 10+ years experience in operations/manufacturing /clinical manufacturing/IS, including cGMP regulated environments
• Good overall understanding of business, manufacturing, and laboratory systems common in the process manufacturing as well as the integration of these systems through applicable standards
• Solid depth or breadth of expertise with offerings within the Lab solution landscape – including ELN, inventory management, MES and scientific analysis tools. Up-to-date knowledge of lab vendor’s software strategy and available competing solutions
• Experience with leading Product Teams to drive features from concept to release while ensuring that business, quality, and functional goals are met with each product release. SAFe or similar experience is a plus
• Demonstrated ability to find opportunities and implement new technologies and services to transform the business into a more agile, efficient and effective organization
• Experience leading a globally distributed enterprise application platform
• Ability to deal with complexity and ambiguity, see the big picture, and drive enable relevant business analyses and facilitate decision-making
• 5 years of supervisory experience leading distributed teams with demonstrated skills in staff motivation, coaching/mentoring and professional development
• Great teammate who is able to collaborate and provide leadership through influence to achieve the required results
• Excellent verbal, written, and communication skills, including the ability to set the context and present on sophisticated subjects to senior management in clear and concise manner
• Understanding of FDA regulations governing computer system validation. Demonstrated working knowledge on automation systems and manufacturing information systems in regulated environments, FDA cGxP and 21 CFR Part 11 regulations, software development lifecycle and system validation
• ERP experience is a plus

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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