Associate Software Engineer – Chemistry, Manufacturing, and Controls

About Amgen

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 Associate Software Engineer is responsible for designing, developing, deploying, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions, automating operations, monitoring system health, and responding to incidents to minimize downtime. This role will involve designing complex systems, optimizing content storage solutions, and integrating third-party services to deliver robust GenAI content authoring and data mapping platforms for Chemistry, Manufacturing, and Controls (CMC.)

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 automate the creation, review, and approval of regulatory content.

Roles & Responsibilities:

• Write clean, efficient, and maintainable code for GenAI content authoring and management systems.
• Build APIs and services to support GenAI content retrieval, storage, and rendering.
• Work on both front-end and back-end components of the Chemistry, Manufacturing, and Controls (CMC) content solutions, creating and integrating React user interfaces and configurations with back-end services in Python.
• Deploy and manage CMC content solution infrastructure using Infrastructure-as-Code, including but not limited to cloud services like AWS RDS, DynamoDB, S3, Lambda, and ECS.
• Assist with the ongoing maintenance of the system, including bug fixes, system upgrades, and enhancements.
• Participate in technical discussions, code and design reviews to help drive the architecture and implementation of new features.
• Create and maintain documentation on software architecture, design, and deployment.
• Stay updated with the latest trends and technologies in content authoring and management, and related fields.
• Work closely with product team, business team, and other stakeholders.
  
  

Basic Qualifications and Experience:

• Bachelor’s degree and 0 to 3 years of Computer Science, IT or related field experience OR
• Diploma and 4 to 7 years of Computer Science, IT or related field experience
  
  

Functional Skills:

Must-Have Skills:

• Strong technical background, including understanding software development processes, databases, and connected systems that require ontologies and data dictionaries to interoperate.
• Proficiency in one or more programming languages such as Java, Python, or JavaScript and familiarity with API-driven data delivery and mapping to ontologies.
• Experience working with databases (SQL/NoSQL).
• Experience with product backlog management (e.g., Jira) and collaboration tools.
  
  

Good-to-Have Skills:

• Experience building and supporting GenAI solutions.
• Experience configuring and maintaining cloud infrastructure for full-stack software solutions, including Infrastructure-as-Code.
• Experience with CI/CD pipelines, version control tools and working in an Agile environment.
• Understanding of international pharmaceutical regulatory submission guidelines and processes (eCTD, ICH, CDS, USPI etc.)
  
  

Professional Certifications:

• NA
  
  

Soft Skills:

• Excellent analytical and troubleshooting skills
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams
• 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
  
  

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.