Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.
ABOUT THE ROLE
You will play a key role in a regulatory submission content automation initiative which will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation. The initiative leverages state-of-the-art technologies, including Generative AI, Structured Content Management, and integrated data to create a foundational knowledge repository for Operations Transformation prioritized initiatives.
Role Description:
The Mgr Data Sciences is a mid-level position responsible for developing interconnected business information and data architecture and ontologies that capture real-world meaning of data by studying the business, our data, and the industry. With a focus on pharmaceutical industry-specific data, including Operations domains such as Process Development, Quality, Manufacturing, Engineering and Supply Chain, this role involves creating robust semantic models based on data-centric principles to realize a connected data ecosystem that empowers consumers. The Information and Data Architect drives seamless cross-functional data interoperability, enables efficient decision-making, and supports digital transformation in pharmaceutical operations.
Roles & Responsibilities:
- Ensure successful delivery of connected data initiatives aligned with Operations Data Strategy roadmap.
- Lead conversations with business stakeholders to elucidate semantic models of pharmaceutical business concepts, aligned definitions, and relationships. Negotiate and debate across stakeholders to drive alignment and create system-independent information models, taking a data-centric approach aligned with business data domains.
- Design, develop and deploy a connected data ecosystem across Operations using, Semantic modeling, R2RML, SPARQL, Generative AI, large language models, GraphRAG
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- Provide technical leadership in Python-based development, SQL-based data transformation, SPARQL retrieval, and AI system design.
- Develop comprehensive business information models and ontologies that capture industry-specific concepts, including CMC, Clinical, and Operations data.
- Facilitate whiteboarding sessions with business subject matter experts to elicit knowledge, drive interoperability across pharmaceutical domains, and interface between data producers and consumers.
- Educate and mentor peers on the practical use and differentiating value of Connected Data and FAIR+ data principles. Champion standards for master data & reference data.
- Formalize data models in RDF as OWL and SHACL ontologies that interoperate with each other and with relevant industry standards like FHIR and IDMP for healthcare data exchange.
- Build a broad semantic knowledge graph that threads data together across end-to-end business processes and enables the transformation to data-centricity and new ways of working
- Guide the development of intelligent systems that combine structured and unstructured data, semantic models, and knowledge graphs.
- Apply pragmatic semantic abstraction to simplify diverse pharmaceutical and healthcare data patterns effectively.
- Drive adoption of FAIR data principles, data-centric design, and semantic interoperability across solutions.
Basic Qualifications and Experience:
[GCF Level 5A]
- Master’s OR Bachelor’s degree with 8 - 12 years of experience Product Owner / Platform Owner / Service Owner / Service Owner
Must-Have Skills:
- Strong problem-solving, analytical, and critical thinking skills to address complex data challenges.
- Deep understanding of pharmaceutical industry data, including Process Development, Manufacturing, Engineering Quality, Supply Chain, and Operations.
- Advanced skills in semantic modeling, RDF, OWL, SHACL, and ontology development in TopBraid and/or Protégé.
- Demonstrated experience creating knowledge graphs with semantic RDF technologies (e.g. Stardog) and testing models with real data.
- Highly proficient with RDF, SPARQL, Connected Data concepts, and interacting with triple stores.
- Highly proficient at facilitating, capturing, and organizing collaborative discussions through tools such as Lucidchart, and Confluence.
- Expertise in FAIR data principles and their application in healthcare and pharmaceutical data models.
Good-to-Have Skills:
- Experience in regulatory data modeling and compliance requirements in the pharmaceutical domain.
- Familiarity with pharmaceutical lifecycle data (PLM), including product development and regulatory submissions.
- Knowledge of supply chain and operations data modeling in the pharmaceutical industry.
- Proficiency in integrating data from various sources, such as LIMS, EDC systems, and MES.
- Hands-on data analysis and wrangling experience including SQL-based data transformation and solving integration challenges arising from differences in data structure, meaning, or terminology
- Expertise in FHIR data standards and their application in healthcare and pharmaceutical data models.
Soft Skills:
- Exceptional interpersonal, business analysis, facilitation, and communication skills.
- Ability to interpret complex regulatory and operational requirements into data models.
- Analytical thinking for problem-solving in a highly regulated environment.
- Adaptability to manage and prioritize multiple projects in a dynamic setting.
- Strong appreciation for customer- and user-centric product design thinking.
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with 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 an accommodation.
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