Senior Downstream Scientist: Manufacturing Support

AGC Biologics A/S; København; On-site; DKK 650,000 - 850,000; Full time

Job summary

AGC Biologics Søborg site is seeking a Senior Downstream Scientist to join Manufacturing Product Support. You will help ensure efficient, compliant production in a cGMP environment and support batch documentation, deviations, and continuous improvement.

The role involves collaborating with Process Transfer, Validation, QA, and QC, taking on additional responsibilities such as customer meetings and audits over time, and participating in on-call support (~24 h/month).

Qualifications

• GMP and downstream processes experience.
• BSc or MSc in natural or life sciences with at least four years in a cGMP manufacturing environment.
• Experience in commercial GMP manufacturing is advantageous.
• Experience writing, reviewing, and approving GMP documentation and deviations, CRs and CAPAs.
• Experience in downstream production support roles.

Responsibilities

• Create and review Master Production Records and batch documentation.
• Facilitate solutions when issues arise during batch execution.
• Ensure timely deviation closure with root cause investigations and CAPAs.
• Represent the team in customer meetings and support audits/inspections when needed.
• Capture learnings and implement continuous process improvements.

Skills

GMP experience

Downstream processes

Communication skills

Problem solving

Team collaboration

Education

BSc or MSc in natural or life sciences

Tools

Single-use technologies

Aseptic processing

Job description

AGC Biologics Søborg site is seeking a Senior Downstream Scientist to join Manufacturing Product Support. You will help ensure efficient, compliant production in a cGMP environment and support batch documentation, deviations, and continuous improvement.

The role involves collaborating with Process Transfer, Validation, QA, and QC, taking on additional responsibilities such as customer meetings and audits over time, and participating in on-call support (~24 h/month).