Upstream MSAT Engineer, NPI & Tech Transfer

No deviation Pte Ltd; Singapore; Presencial; SGD 100 000 - 160 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

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Resumo da oferta

No Deviation Pte Ltd is seeking an Upstream MSAT Engineer to lead NPI and technology transfer for biologics at our Singapore site. You will provide senior technical guidance to the PD team on investigations, process performance, and risk-based recommendations.

The role requires strong biologics process knowledge, manufacturing experience, and the ability to work within a regulated cGMP environment, delivering cross-network alignment and continuous improvement.

Qualificações

• Master's degree with 4+ years directly related experience, or Bachelor's with 6+ years of related experience.
• 6+ years of relevant experience in commercial biotech/pharma manufacturing.
• At least 4 years of experience in regulated environments (e.g. cGMP).
• Preferred: in-depth cell culture and/or purification process knowledge, including single-use and harvest technologies.
• Preferred: understanding of process characterization and scale-up to resolve issues during transfer and large-scale manufacturing.
• Preferred: experience in technology transfer of new processes to a commercial site.
• Preferred: strong technical writing, verbal communication and presentation skills.
• Preferred: experience leading small teams and projects in regulated settings

Responsabilidades

• Independently lead assigned NPI and technology transfer workstreams and document risks.
• Translate process characterization and scale-up knowledge into site requirements.
• Identify technical gaps, develop mitigation options, and escalate decisions to leadership.
• Provide scientific and engineering support for cell culture, harvest, and purification processes.
• Evaluate manufacturing performance and complex process issues using data and engineering principles.
• Collaborate with Manufacturing, Quality and other functions to resolve process challenges.
• Lead complex deviation investigations with hypothesis development and data assessment.
• Integrate data to reach scientifically justified conclusions and risk-based recommendations.
• Coach engineers in problem solving and clear technical communication to stakeholders

Conhecimentos

Regulated manufacturing experience

cGMP knowledge

Cell culture knowledge

Process characterization

Technical writing

Strong communication

Formação académica

Master's degree in Engineering/Science

Bachelor's degree in Engineering/Science

Descrição da oferta de emprego

No Deviation Pte Ltd is seeking an Upstream MSAT Engineer to lead NPI and technology transfer for biologics at our Singapore site. You will provide senior technical guidance to the PD team on investigations, process performance, and risk-based recommendations.

The role requires strong biologics process knowledge, manufacturing experience, and the ability to work within a regulated cGMP environment, delivering cross-network alignment and continuous improvement.