MSAT Process Development Engineer - Tech Transfer & NPI

Amgen Inc. (IR); Singapore; Presencial; SGD 85 000 - 120 000; Tempo integral

Resumo da oferta

Amgen Inc. (IR) in Singapore is seeking a Process Development Engineer (MSAT) to coordinate tech transfer, qualification, and performance monitoring across unit operations.

The role supports NPI and lifecycle changes by aligning process design with site procedures and capabilities. The ideal candidate will have a Master’s or Bachelor’s with relevant experience, 4+ years in biotech/pharma manufacturing, and strong problem-solving and communication skills.

Qualificações

• Master’s degree OR Bachelor’s degree and 2 years of directly related experience OR Associate’s degree and/or 6 years of directly related experience OR High school diploma / GED and 8 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
• Good cell culture and/or purification process knowledge, including single-use technologies
• Experience in troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
• Problem solving skills requiring the application of strong scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
• Demonstrated working knowledge of applicable regulatory and cGMP requirements
• Ability to learn and act on dynamic information at a rapid pace and elevate relevant issues to management when required
• Self-motivation, adaptability and a positive attitude
• Excellent communication skills, both oral and written

Responsabilidades

• Coordinate assigned non-routine activities including technology transfer, process qualification, performance monitoring and troubleshooting
• Support NPI and lifecycle changes by integrating process design with site procedures
• Support make-a-batch exercises to assess facility fit and identify gaps
• Support process feasibility and control strategy development for new equipment/technology
• Lead investigations within defined scope and communicate findings to teams and leadership
• Build and maintain tech transfer efficiency tools and templated documents
• Collaborate with drug substance tech teams, NPI, QA, Supply Chain and manufacturing to align program needs with site capabilities
• Utilize strong technical and verbal communication in deviation assessment and presentations

Conhecimentos

Process engineering

cGMP

Investigations & deviation handling

Cell culture knowledge

Troubleshooting

Communication skills

Formação académica

Bachelor’s or Master’s degree

Ferramentas

Single-use systems

QA systems

Descrição da oferta de emprego

Amgen Inc. (IR) in Singapore is seeking a Process Development Engineer (MSAT) to coordinate tech transfer, qualification, and performance monitoring across unit operations.

The role supports NPI and lifecycle changes by aligning process design with site procedures and capabilities. The ideal candidate will have a Master’s or Bachelor’s with relevant experience, 4+ years in biotech/pharma manufacturing, and strong problem-solving and communication skills.