Amgen Specialist Manufacturing in Singapore, Singapore

Specialist Manufacturing

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.

Job Responsibilities

  • 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

Basic Qualifications

  • Doctorate degree in Science and 2 years of directly related experience OR

  • Master's degree in Science and 5 years of directly related experience OR

  • Undergraduate degree in Science and 8 years of directly related experience OR

  • Undergraduate diploma in Science and 10 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.