Senior Downstream Scientist, Commercial Biologics

AGC Biologics, Inc.; København; Hybrid; DKK 900.000 - 1.100.000; Vollzeit

Zusammenfassung

AGC Biologics, Søborg site in Denmark, seeks a Senior Downstream Scientist to lead technical support for commercial biologics manufacturing. You will own documentation, drive change control, and lead investigations while collaborating across MSAT and manufacturing teams to ensure compliance and product quality.

You will apply downstream processing expertise across chromatography, UF/DF, and purification, with hands-on experience on ÄKTA/UNICORN, data analysis, and GMP regulatory requirements to

Qualifikationen

• MSc in Biochemistry, Chemistry, Biology, Bioprocess with 6+ years of pharma industry experience, or a PhD in one of these fields with 4+ years.
• Solid understanding of downstream processing and hands-on chromatography experience across affinity, ion exchange, HIC, and mixed-mode systems.
• Familiarity with ÄKTA/UNICORN software; UF/DF; mammalian and microbial expression systems; GMP & regulatory knowledge (ICH Q7A, 21 CFR Part 211).
• Experience writing/reviewing technical docs, coordinating multi-department tasks, and leading change control.

Aufgaben

• Lead technical support for commercial downstream processes and documentation ownership within MSAT.
• Drive change control activities and investigations for deviations.
• Represent MSAT in client meetings, audits, and regulatory discussions.
• Provide technical training and sparring across teams to enable process improvements.

Kenntnisse

Downstream processing

Chromatography

Data analysis

Cross-functional collaboration

Documentation & GMP

Ausbildung

MSc in Biochemistry/ Chemistry/ Biology/ Bioprocess

PhD in related field

Tools

ÄKTA

UNICORN

UF/DF

Jobbeschreibung

AGC Biologics, Søborg site in Denmark, seeks a Senior Downstream Scientist to lead technical support for commercial biologics manufacturing. You will own documentation, drive change control, and lead investigations while collaborating across MSAT and manufacturing teams to ensure compliance and product quality.

You will apply downstream processing expertise across chromatography, UF/DF, and purification, with hands-on experience on ÄKTA/UNICORN, data analysis, and GMP regulatory requirements to