Senior Downstream Scientist, MSAT & Process Excellence

AGC Biologics, Inc.; København; Hybrid; DKK 900,000 - 1,300,000; Full time

Job summary

AGC Biologics is seeking an experienced Senior Downstream Scientist to strengthen our MSAT team in Denmark. You will lead technical documentation, deviations investigations, and change control for commercial manufacturing, while collaborating across departments to drive process improvements and ensure regulatory compliance.

You will build expertise in chromatography methods, execute scalable purification strategies, and participate in client meetings and regulatory submissions.

Qualifications

• MSc in Biochemistry, Chemistry, Biology, Bioprocess or related field with 6+ years of pharma experience, or PhD with 4+ years of pharma experience.
• Strong chromatography knowledge including affinity, ion exchange, hydrophobic interaction, and mixed-mode chromatography.
• Experience with column packing, performance testing, maintenance, scaling, and validating chromatography methods for biomolecule purification.
• Familiarity with ÄKTA and UNICORN, UF/DF processes, and mammalian/microbial expression systems.
• Experience with GMP and regulations such as ICH Q7A and 21 CFR Part 211.
• Proven ability to write, review, and approve technical documentation and coordinate multi-department projects.

Responsibilities

• Provide technical leadership and owner-ship of commercial MSAT support and documentation.
• Lead process change management, post-batch evaluations, and process improvement initiatives to enhance efficiency and quality.
• Contribute to regulatory dossiers and support inspections and audits for full compliance.
• Lead assessments for operations deviations and support deviation investigations and change control with the team.
• Represent MSAT in client meetings and provide cross-team sparring and technical training.

Skills

Downstream processing

Chromatography

Data analysis

GMP knowledge

Education

MSc in Biochemistry/ Chemistry/ Biology/ Bioprocess

PhD in related field

Tools

ÄKTA

UNICORN

UF/DF

Job description

AGC Biologics is seeking an experienced Senior Downstream Scientist to strengthen our MSAT team in Denmark. You will lead technical documentation, deviations investigations, and change control for commercial manufacturing, while collaborating across departments to drive process improvements and ensure regulatory compliance.

You will build expertise in chromatography methods, execute scalable purification strategies, and participate in client meetings and regulatory submissions.