Senior Downstream Scientist: Manufacturing Product Support

AGC Biologics; København; Presencial; DKK 600 000 - 800 000; Tempo integral

Resumo da oferta

AGC Biologics is seeking a Senior Downstream Scientist to join the Manufacturing Product Support team in a Danish site. The role focuses on supporting production with cGMP governance, ensuring timely deviation handling, and maintaining quality documentation while collaborating across Process Transfer, Validation, Engineering, QA and QC.

The ideal candidate will bring strong downstream process knowledge, hands-on GMP experience, and a proactive approach to troubleshooting and continuous

Qualificações

• Requires experience in writing, reviewing and approving GMP documentation.
• Experience in cGMP manufacturing environment is preferred.
• Strong communication and collaboration skills across multiple departments.

Responsabilidades

• Create and review Master Production Records and batch documentation.
• Facilitate solutions when issues or breakdowns occur during batch execution.
• Close deviations timely with root cause investigations and CAPAs.
• Lead troubleshooting and represent the team in customer meetings and audits.

Conhecimentos

GMP experience

Downstream processing

Documentation write/review

Root cause analysis

On-call support

Formação académica

BSc/MSc life sciences

Ferramentas

Single-use technologies

Aseptic processing

Descrição da oferta de emprego

AGC Biologics is seeking a Senior Downstream Scientist to join the Manufacturing Product Support team in a Danish site. The role focuses on supporting production with cGMP governance, ensuring timely deviation handling, and maintaining quality documentation while collaborating across Process Transfer, Validation, Engineering, QA and QC.

The ideal candidate will bring strong downstream process knowledge, hands-on GMP experience, and a proactive approach to troubleshooting and continuous