Amgen Manufacturing Specialist in Singapore, Singapore

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. Areas of scope and responsibilities include:

Change control ownership

Nonconformance investigation ownership.

Troubleshooting of Non-Conformances and working with Quality, F&E, EH&S, P&PD, P&PE etc to address CAPAs.

Work very closely with Regulatory and Quality partners to manage change control processes and respond to regulatory questions and/or audit findings.

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.

Technical expert who helps introduce advanced process technologies and approaches - generally described as 'Manufacturing of the Future' - into the plant.

Basic Qualifications

  • Doctorate degree

OR

  • Master's degree & 3 years of directly related experience

OR

  • Bachelor's degree & 5 years of directly related experience

OR

  • Associate's degree & 10 years of directly related experience

OR

  • High school diploma / GED & 12 years of directly related experience

Preferred Qualifications

  • Master's degree in Chemical Engineering or Life Sciences

  • 5+ years experience in GMP Tech Support roles, GMP operations or process

development.

  • 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

commercialization program