This role is within the manufacturing organization of Amgen Singapore Manufacturing. The Mfg Specialist is a key role to support the manufacturing shift in successful execution. We offer a broad exposure to all key aspect of GMP manufacturing as well as tactical and strategic teamwork within the extended manufacturing network.
Responsible for investigating and reporting on deviations to the manufacturing process.
Work with relevant subject matter experts from all departments in the course of an investigation. Collaboration between departments is required for the completion of an investigation and the implementation of appropriate CAPAs.
Carry out technical write-up and functional review of investigations for non-conforming events
Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
Work very closely with Regulatory and Quality partners to manage change control processes and respond to regulatory questions and/or audit findings. Manage change control processes and CAPAs in relation to Regulatory Agency’s Pre Approval Inspection – Response to Questions (RTQ)
Operations Excellence plant core team member who champions OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.
Ability to coach, mentor and/or cross train colleagues within core technical areas
Understands the core functional business processes and their role in Amgen's commercialization program
• Doctorate degree
• Master’s degree & 3 years of directly related experience
• Bachelor’s degree & 5 years of directly related experience
• Associate’s degree & 10 years of directly related experience
• High school diploma / GED & 12 years of directly related experience
• Master's degree in Chemical Engineering or Life Sciences
• 5+ years experience in GMP Tech Support roles, GMP operations or process
• Extensive technical knowledge of upstream or downstream processing and
broad understanding of related disciplinary areas
• Ability to design and execute a technical study with minimal guidance
• Ability to organize, analyze, and interpret technical data through trend analysis,
forecasting, modeling, etc.
• Ability to effectively communicate complex technical information with internal and
external colleagues of varying organizational levels in both presentation and
technical writing forms
• Ability to coach, mentor and/or cross train colleagues within core technical areas
• Understands the core functional business processes and their role in Amgen's
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.