Process Development Scientist – Commercial Support

About the role

Join Amgen’s commercial manufacturing team as a Process Development Scientist. You will support the parenteral manufacturing plant by monitoring processes, driving improvements, and ensuring reliable delivery of life‑changing therapies.

Key responsibilities

• Support process monitoring, improvement initiatives, and technology transfers for formulation and aseptic drug product manufacturing.
• Investigate deviations, perform root‑cause analysis, assess product impact, and implement corrective and preventive actions.
• Author and contribute to technical documents, protocols, reports, presentations, and regulatory‑support documentation.
• Stay current with scientific literature and internal best practices, sharing insights with project teams.
• Collaborate cross‑functionally with Manufacturing, Quality, Engineering, Process Development, and other internal partners.
• Perform data analysis, draw technical conclusions, and provide recommendations.
• Ensure compliance with safety, quality, regulatory, and cGMP requirements.
• Participate in department initiatives such as safety programs, continuous improvement, training, and knowledge‑sharing forums.

Required profile

• Collaborative, technically strong individual contributor.
• Doctorate degree, or a Master’s degree with at least 2 years of relevant experience, or a Bachelor’s degree with at least 4 years of scientific, process development, laboratory, or manufacturing support experience.

Required skills

• Process monitoring and improvement
• Technology transfer
• Root‑cause analysis and CAPA implementation
• Data analysis and technical reporting
• cGMP compliance