Process Development Senior Engineer

Amgen is hiring a Process Development Senior Engineer in Amgen Singapore Manufacturing to assume a Subject Matter Expert role within ASM Process Development for cell culture commercial process support. The role requires leading complicated investigations, integrating trends and data, and collaborating with cross-functional teams.

Requirements

• Assume a Subject Matter Expert role within ASM Process Development for cell culture commercial process support.
• Act as Drug Substance Team Leader within the global Product Development Team (PDT); providing stewardship of product lifecycle and process improvement.
• Lead complicated investigations independently, providing concise communications to teams and leadership
• Integrate trends, data and information into plans, deliverables and recommendations
• Manage key projects to deliver site goals while meeting quality, schedule, and cost objectives.
• Lead productivity projects, process optimization, and product life cycle management.
• Collaborate with cross-functional teams and network drug substance teams to resolve process challenges by applying advanced technical principles and concepts for troubleshooting.
• Apply best practices to leverage data for more proactive and predictive approaches.
• Support regulatory filings, audits and inspection, and other CMC activities (e.g author and review regulatory submissions and responses to questions as required).
• Provide floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
• Technology Transfer of new process and technology to commercial site.
• Lead small team and lead projects

Benefits

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits