Senior Downstream Scientist, MSAT (Temporary Cover)

AGC Biologics A/S; København; On-site; DKK 800,000 - 1,100,000; Full time

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

Help strengthen commercial downstream processes for complex biologics At AGC Biologics, you will help support the manufacturing of commercial biotechnological products where operational efficiency, regulatory compliance, and product quality are critical.

As Senior Downstream Scientist in our MSAT Department, you will join a dedicated team of scientists supporting commercial manufacturing processes and driving continuous improvement initiatives for complex biotechnological products.

This is a role for an experienced scientist who combines advanced technical problem‑solving skills with a passion for delivering life‑saving products to patients.

Drive technical excellence across commercial manufacturing

You will take a central role in the technical support of our commercial projects and act as the primary owner and driver of technical documentation within the MSAT organization, ensuring accuracy, completeness, and consistency.

You will take responsibility for process change management and post‑batch evaluations, while driving process improvement initiatives that strengthen efficiency and quality.

You will also author and review relevant technical sections of regulatory dossiers and provide leadership during inspections and audits to support full compliance.

A key part of the role will be leading assessments supporting technical operations deviations and supporting deviation investigations and change control processes together with the team.

As a subject matter expert, you will contribute to technical discussions and represent the team in client project meetings.

You will provide technical leadership and sparring across teams and departments and contribute to critical decisions and the creation of milestones for MSAT.

Bring your downstream expertise into a highly technical role

Your experience within downstream processing will enable you to interpret purification performance, analyze process trends, and contribute to the continued development and improvement of commercial manufacturing processes.

We are looking for someone who brings:

• An MSc in Biochemistry, Chemistry, Biology, Bioprocess, or a related field with 6+ years of relevant pharmaceutical industry experience, or a PhD within one of these fields with 4+ years of relevant pharmaceutical industry experience.
• Solid understanding of downstream process principles combined with hands‑on experience across chromatography techniques such as affinity, ion exchange, hydrophobic interaction, and mixed‑mode chromatography.
• This includes chromatography column packing, performance testing, maintenance, and experience developing, scaling, and validating chromatography methods for biomolecule purification.
• Familiarity with industry‑standard chromatography systems such as ÄKTA and related software such as UNICORN, as well as experience with ultrafiltration and diafiltration (UF/DF) processes and both mammalian and microbial expression systems and their associated purification challenges.
• Strong data analysis capabilities and experience using statistical software such as JMP or Minitab for process monitoring, validation, and improvement, combined with extensive experience and a solid understanding of Good Manufacturing Practices (GMP) and applicable regulations such as ICH Q7A and 21CFR Part211.
• Proven experience writing, reviewing, and approving technical documentation, communicating extensively with internal and external clients, coordinating multi‑departmental tasks and deliverables, and managing multiple projects simultaneously.
• The ability to build effective working relationships across departments to support new processes and products, together with experience providing technical training and sparring.

Bring your expertise to AGC Biologics

AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in Denmark. From our Søborg site, we develop and manufacture life‑changing advanced biologics for some of the world’s most innovative pharmaceutical companies.

Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial‑based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cell therapies.

Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Who We Are

AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in Denmark. From our Søborg site, we develop and manufacture life‑changing advanced biologics for some of the world’s most innovative pharmaceutical companies.

Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial‑based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies.

Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

AGC Biologics is Your Friendly CDMO Expert – dedicated partners with the expertise and commitment to support our customers and teams.

We work with some of the world’s most innovative pharmaceutical companies to develop and manufacture their life‑changing drug products.