Senior Downstream Scientist - Biologics MSAT & Process Excellence

AGC Biologics A/S

København

On-site

DKK 800,000 - 1,100,000

Full time

4 days ago

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Job summary

AGC Biologics is seeking a Senior Downstream Scientist to strengthen technical leadership in its MSAT team. You will support commercial biopharma manufacturing, drive process improvements, and own technical documentation across projects.

The role emphasizes chromatography, UF/DF, data analysis, and GMP-compliant change controls, with collaboration across departments to prepare for audits and regulatory submissions.

Qualifications

Advanced degree with pharma industry experience in downstream processing.
Hands-on chromatography and purification method development.
Experience with GMP, regulatory dossiers, and audits.

Responsibilities

Lead technical documentation and change management for commercial programs.
Assess deviations, investigations, and change controls in MSAT.
Develop, scale, and validate chromatography and purification methods.
Collaborate across departments to support regulatory submissions.

Skills

Downstream processing

Chromatography

Data analysis

Documentation control

GMP awareness

Education

MSc in Biochemistry, Chemistry, Biology, Bioprocess or related field

PhD with 4+ years pharma experience

Tools

ÄKTA

UNICORN

JMP

Minitab

UF/DF systems

Job description

The role emphasizes chromatography, UF/DF, data analysis, and GMP-compliant change controls, with collaboration across departments to prepare for audits and regulatory submissions.

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