Process Development Engineer – Biotech, cGMP & Data-Driven

Amgen Inc. (IR); Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

Amgen is seeking a Process Development Engineer to coordinate complex manufacturing activities, perform data-driven analyses, and support regulatory filings. You will work with cross-functional teams to ensure robust process development and compliant operations.

The role requires strong cell culture knowledge, cGMP experience, and proficient communication. Opportunity to contribute to impactful therapies and grow within a global biotech leader.

Qualifications

• Master's degree OR Bachelor's degree and 2 years of directly related experience OR Associate's degree and/or 4 years of directly related experience OR High school diploma / GED and 6 years of directly related experience.
• 4+ years of relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industries.
• At least 2 years' experience with regulated environments (i.e. cGMP) required.
• In depth cell culture process knowledge, including single-use technologies and harvest technologies.
• Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production.
• Possess basic understanding of regulatory and cGMP requirements.
• Able to apply engineering principles and advanced statistical analysis in-in order to solve processing issues and evaluate opportunities for process improvements.
• Able to escalation relevant issues to project lead and line management.
• Independently motivated but also work well in team environment.
• 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.

Responsibilities

• Coordinate complex non-routine activities including tech transfer qualification.
• Lead investigations and provide concise communications to teams and leadership.
• Analyze process data using Excel, JMP, SIMCA to inform decisions.
• Author technical protocols, assessments, and product impact assessments.
• Verify data in technical reports and regulatory filings.
• Communicate clearly in technical writing and presentations.
• Support cGMP production and assist in regulatory compliance.

Skills

GMP experience

Cell culture

Troubleshooting

Technical writing

Process engineering

Education

Master's degree in related field

Bachelor's degree in related field

Associate's degree

High school diploma

Tools

Excel

JMP

SIMCA

Job description

Amgen is seeking a Process Development Engineer to coordinate complex manufacturing activities, perform data-driven analyses, and support regulatory filings. You will work with cross-functional teams to ensure robust process development and compliant operations.

The role requires strong cell culture knowledge, cGMP experience, and proficient communication. Opportunity to contribute to impactful therapies and grow within a global biotech leader.