QUALIFICATIONS

• Doctorate degree OR
• Master’s degree and 2 years of directly related experience OR
• Bachelor’s degree and 4 years of directly related experience OR
• Diploma and 8 years of directly related experience
• Relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industries
• Experience with regulated environments (i.e. cGMP) required
• In depth cell culture process knowledge, including disposables technologies and harvest technologies
• Experienced in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
• Comprehensive understanding of commissioning, qualification and verification protocol execution requirements
• Comprehensive experience in process characterization and process monitoring programs
• Strong communication skills (technical writing and verbal communication/presentation)
• Problem solving skills requiring the application of strong scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
• Familiarity with documentation in a highly regulated environment
• Interacts effectively with variety of communication and working styles
• Ability to independently determine when additional resources are required to solve problems
• Demonstrated skills in the following areas:
• Basic project management
• Commissioning and Qualification
• Scheduling
• Collaboration
• Completion and follow-up
• Ability to provide solutions to a large variety of technical problems

WHAT YOU WILL DO

Let’s do this. Let’s change the world. In this vital role you, the PD Senior Engineer will provide scientific and technical leadership within the Process Development group at Amgen’s Next Generation Biologics Manufacturing Facility in Singapore. This is one of the most advanced biotech manufacturing facilities in the world: employing the latest technologies for single use processing, connected processing, and real-time process analytical technologies.

Main Responsibilities:

• Assume a Subject Matter Expert role within ASM Process Development for cell culture and commercial process support.
• Experienced in Technology Transfer of new process and technology to commercial site.
• Must have strong knowledge of cell culture and product recovery.
• Must have good understanding of process characterization and process scale up to resolve technical issues observed during transfer / manufacturing at large scale.
• Able to lead small team and lead projects focused on non-routine activities including facility start up, process qualification through to regulatory filing, process performance monitoring, floor support, and troubleshooting of unit operations.
• 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, complex investigation, 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.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.