Career CategoryInformation SystemsJob Description
The "Senior Manager - Lab Systems" within Operations IS (OIS) will be responsible for the successful management and execution of all the IS activities supporting the Process Development (PD) and Quality Control (QC) organizations. 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 OIS will serve as owner of the Holistic Lab Platform and lead the IS team that supports the Amgen Lab Systems globally. 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 will report to Head of Global IS Process Development, primary location is Thousand Oaks but can be other locations of Amgen will be considered. Travel is anticipated to be approximately 20% to support globally distributed staff and portfolio execution.
Specific Responsibilities are:
Own, manage, and support Lab Systems Portfolio
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
Provide vision and lead implementation of digital lab initiatives providing experiment design, authoring, and execution solutions
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
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
Demonstrated ability to find opportunities and implement new technologies and services to transform the business into a more agile, efficient and effective organization
Knowledge of enterprise software and cloud architecture and structure of software solutions
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
4+ 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 complex 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
Doctorate degree and 2 years of Information Systems experience
OR Master's degree and 6 years of Information Systems experience
OR Bachelor's degree and 8 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
4 +years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
We understand that to successfully sustain and grow as a global enterprise and deliver for patients we must ensure a diverse and inclusive work environment. 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.
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.