Principal Business Analyst - Serialization

Overview

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

Role Description:

The role is responsible for leading and charting the course for the Global Supply Chain Serialization Domain. SAP Serialization Solutions Lead will design, implement, and manage serialization solutions that ensure product integrity, regulatory compliance, and supply chain transparency. This role will be key contributor to Serialization Product Team serving as technical consultant as well as liaison between IT and business stakeholders, ensuring technical solutions align with compliance requirements, operational needs, and strategic objectives.

The ideal candidate will have deep expertise in SAP Advanced Track & Trace for Pharmaceuticals (ATTP), Tracelink, SAP ICH (Information Collaboration Hub) or equivalent serialization systems, with strong technical background, business analysis and client-facing skills to translate requirements into scalable, reliable solutions.

Roles & Responsibilities:

• Lead the design, configuration, and support of SAP ATTP (Serialization), SAP ICH, and related systems to meet global regulatory and business requirements.
• Translate business needs into functional and technical specifications for serialization and supply chain traceability.
• Oversee end-to-end implementation of serialization solutions, including integration with ERP, manufacturing, packaging, and partner systems.
• Ensure compliance with DSCSA, EU FMD, and other regional/global serialization regulations.
• Ensure adoption of AI driven tools and collaborating with business to identify AI driven use cases.
• Collaborate with geographically dispersed teams, including those in the US and other international locations.
• Serve as the primary point of contact for business stakeholders, understanding needs, gathering requirements, and providing thought leadership.
• Conduct workshops, stakeholder interviews, and requirements-gathering sessions to capture functional and compliance need to be maintained and prioritized in a Product Backlog.
• Translate complex technical capabilities into business-friendly language, facilitating alignment across IT and business functions.
• Partner with Supply Chain, Quality, Regulatory, and Commercial teams to ensure serialization solutions drive measurable business value.
• Maintain system documentation, business process workflows, and compliance reporting.
• Ensure cross-team alignment and manage risks, escalations, and interdependencies.
• Work with Operation Team to ensure proper Serialization system monitoring, identify improvement opportunities, and drive continuous optimization.
• Lead vendor and partner relationships, ensuring quality delivery and alignment with business objectives.
• Build and maintain relationships across IT, business units, and enterprise leadership to align strategy and execution.
• Provide guidance, mentoring, and knowledge-sharing across IT and business analyst teams.
  
  

• Master’s degree with 8 - 10 years of experience in Business, Engineering, IT or related field OR
• Bachelor’s degree with 10 - 14 years of experience in Business, Engineering, IT or related field OR
• Diploma with 14 - 18 years of experience in Business, Engineering, IT or related field
  
  

• Demonstrated experience with at least 5 years focused on SAP ATTP, ICH and serialization ecosystem.
• Strong knowledge of SAP ERP (ECC/S4), SAP EWM, supply chain processes, and integrations with packaging as well as CMO and Logistics partners.
• Strong understanding of pharmaceutical/life sciences regulatory requirements for serialization and track-and-trace (DSCSA, EU FMD, Brazil ANVISA, etc.).
• Experience working in GxP or other regulated environments (e.g., pharmaceutical, life sciences, or healthcare).
• Proven track record as a business analyst or client-facing IT leader, bridging gaps between technology and business.
• Excellent facilitation, communication, and stakeholder management skills.
  
  

• Experience in a leadership role within a pharmaceutical or technology organization
• Extensive experience in software development lifecycle.
• Strong analytic/critical-thinking and decision-making abilities.
• Ability to work effectively in a fast-paced, dynamic environment.
• Established business partnerships and IS governance practices involving senior business stakeholders
• Broad working knowledge of key IS domains and layers
  
  

• SAFe Agile Practitioner (preferred)
  
  

• Excellent leadership and team management skills.
• Strong transformation and change management experience.
• Exceptional collaboration and communication skills.
• High degree of initiative and self-motivation.
• Ability to manage multiple priorities successfully.
• Team-oriented with a focus on achieving team goals.
• Strong presentation and public speaking skills.
• Excellent analytical and troubleshooting skills
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams
  
  

This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

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 accommodation.