Role Description
Let’s do this. Let’s change the world. In this vital role you will work as part of a Product Team focusing on Unified Lab Management (ULM) platform accelerating Amgen’s product development and commercial manufacturing working together with a dynamic team of technical product owners, business analysts, test/validation engineers, project managers and scrum masters on the design, development, management, and optimization of Amgen Operation’s Electronic Lab Notebook and Instrument Data Acquisition Platform.
The role requires strong expertise in ELN Applications, Enterprise Application Integration, end-to-end data and process harmonization, as well as handling the seamless integration of Lab Instrument data to various enterprise business applications. This individual will manage key vendors and partner with stakeholders orchestrating the implementation of solutions that enable next generation lab processes including simulations, machine learning and knowledge management.
They should also have experience leading and effectively working with large, diverse and globally dispersed teams within a matrixed organization. Extensive collaboration with global cross functional teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in the end-to-end software development lifecycle, technical product ownership, business analysis, be a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational critical initiatives, develop a collaborative environment, and deliver high-quality results in a matrixed organizational structure.
Roles & Responsibilities
Serves as a technical leader across multiple teams
Coaches mid-level and senior software development engineers
Drive architectural decisions across multiple projects
Maintain technical excellence and scalability in products
Design, develop, and implement IS solutions to enable end to end digitization of lab experimentation, simulations and electronic recipe management across Operations.
Actively engage with business users to analyze business needs, identify technology solutions capture, and document design guided by best practices in Agile development.
Collaborate with IS Architects and System Owners to implement an integrated solution across PLM, ERP, MES, and Enterprise Data Lake
Perform hands-on development of technology solutions including configuration of commercial software as well as extensions and integrations
Represents software development team in cross-functional leadership meetings
Serve as lead Solution Engineer: as well as oversee external contractors and consultants
Review project deliverables throughout development to ensure quality and traceability to requirements and adherence to all quality management plans and standards. Participate in IS quality validation reviews.
Oversee the backlog of requirements/user stories
Collaborate with Platform Owners, Product Owners, Service Owners, and delivery teams to ensure delivery matches commitments, acting as a critical issue point and facilitating communication when service commitments are unmet.
Ensure overall compliance with quality and GxP in technology services, monitor emerging technologies and trends for platform growth, and ensure ongoing alignment with strategy, compliance, and regulatory requirements.
Basic Qualifications
Master’s degree with 8 - 14 years of experience in Engineering, IT or related field OR
Bachelor’s degree with 10 - 16 years of experience in Engineering, IT or related field OR
Functional Skills
Must-Have Skills
Extensive experience designing, configuring and coding software including custom development and commercial software packages using APIs, while working within an Agile Environment and contributing to ceremonies
Experience with integration standards, including Web Services, SOAP, REST
Skilled with object-oriented design/development and semantic web standards
Experience with development languages such as Java, Python, Pipeline Pilot, C# a plus
Ability to learn new software, troubleshoot and display critical thinking techniques within improvements
Strong database management experience with SQL RDBMS and SPARQL; working with Big Data integration and Analytics a plus
Experience integrating solutions with ERP, and MES platforms is a plus
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 computer system validation and SDLC in biotech manufacturing and laboratory areas.
Excellent verbal, written, and interpersonal communication skills, including the ability to set the context and present sophisticated subjects to senior management in a clear and concise manner.
Experience building productive resourceful working relationships with business clients
Strong leadership, project management skills.
Proven leadership skills with the ability to lead large matrixed teams. In addition, demonstrated experience in leading and developing a hard-working team of technology professionals, building a culture of innovation and continuous improvement within the team to deliver powerful solutions and platform improvements.
Experience in implementing a strategic roadmap and driving transformation initiatives using Scaled Agile methodology.
Strong skills in collaborating and communicating with cross-functional teams, business collaborators, and executives to ensure alignment of platform initiatives with business outcomes, handling expectations, and ensuring successful delivery of projects.
Preferred Skills
Solid depth or breadth of expertise with offerings within the Lab solution landscape – including ELN, inventory management, MES and scientific analysis tools
At least 5 – 8 years of domain knowledge in health and/or life sciences combined with Information Technology
Understanding and applied experience in Lab Informatics and cross functional data harmonization
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
Up-to-date knowledge of vendor’s software strategy, information of available competing solutions and the ability to translate these to the changing business environment in PD such that we can continually maximize software investments.
Experience managing a globally distributed enterprise application platform
Leadership experience within a highly regulated pharmaceutical or technology organization, with the ability to ensure compliance with industry regulations and standard methodologies for GxP software validation.
Experience directing solution design, business processes redesign and software implementation in a drug development lab / commercialization environment
Understanding of FDA regulations governing computer system validation and operation in biotech manufacturing and laboratory areas
Strong analytic/critical-thinking and decision-making abilities.
Demonstrated ability to work effectively in a fast-paced, dynamic environment.
Extensive experience in the software development lifecycle.
Experience using and adoption of Scaled Agile Framework (SAFe)
Understanding of ITIL processes and implementation.
Established business partnerships and IS governance practices involving senior business stakeholders
Experience handling vendor relationships and working with external partners or consultants to ensure optimal performance, support, and development of digital products.
Soft Skills
Excellent leadership and team management skills.
Strong transformation and change management experience.
Ability to work effectively with global, virtual teams.
Excellent analytical and troubleshooting skills.
Ability to manage multiple priorities successfully.
Strong presentation and public speaking skills.
Strong verbal and written communication skills.
High degree of initiative and self-motivation.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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