Career Category

Job Description

Amgen Singapore Manufacturing is responsible for drug substance manufacturing and release of Amgen’s commercial product using innovative manufacturing platforms and technologies. This role resides within the ASM2 Manufacturing support function and is primarily responsible for providing process and New Product Introduction (NPI) support for all synthetic products and process equipment. In addition to the main support responsibilities including management of changes, driving deviation investigations and resolving process interruptions, he/she is also responsible for production finite scheduling, Operation Excellence, management of overall training program and managing of site-wide projects. This role requires highly cross functional interactions with key site functions to ensure success in production and release performance. It offers a broad exposure to all key aspects of GMP manufacturing as well as tactical and strategic teamwork within the extended worldwide manufacturing network.

Responsibilities
 

• Own and manage deviations including major or complex deviations; lead cross functional team in investigations and implementation of corrective/preventive actions.
• Own and manage change controls (including level 2 change) and ensure timely implementation and closure of records using sound project management and technical knowledge to drive changes to meet business needs and compliances.  
• Production planning and finite scheduling; coordinate with cross functional team to execute production plan and resolve issues if needed to ensure schedule adherence.   
• Lead or support technology transfer for NPI and improvement projects as per business needs and assignment.
• Ensure on time in full disposition performance by delivering deviation, change control components of release
• Escalate and address risks and opportunities found in manufacturing facilities, equipment, processes, and procedures
• Build and maintain a robust support function to perform assigned quality management activities such as deviation, change control, CAPA management
• Present key investigations and quality management system records in all site regulatory inspections
• Drive/ support site wide Operational Excellence and lean transformation programs; drive technical and non-technical continual improvement initiatives to increase production and disposition agility

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.

Qualifications

Bachelor or Master’s Degree in a technical field, including Chemical/Mechanical Engineering, Chemistry or Pharmaceutical Sciences.

• Minimum 5 years of work experience in pharmaceutical manufacturing industry; preferably in Active Pharmaceutical Ingredient.
• Possess good analytical/problem solving and written / verbal communication skills.
• 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