Senior Scientist for Late-Stage Downstream Process Development

AGC Biologics A/S; København; On-site; DKK 700,000 - 900,000; Full time

Job summary

AGC Biologics A/S in Søborg, Denmark, is seeking a Senior Downstream Scientist for its Late-stage Process Development department. You will lead downstream development projects for mammalian and microbial workflows, applying rigorous experimental design, statistical analysis, and scientific leadership to drive projects forward.

Responsibilities include coordinating development activities, designing and executing advanced experiments, authoring protocols and development reports, and contributing

Qualifications

• Master's or PhD in Biochemistry, Biochemical Engineering, Process Technology, or similar.
• 5+ years of industrial downstream experience (Master's) or 2+ years (PhD).
• Proven experience in downstream process development and ability to plan/report complex studies.
• Excellent communication and teamwork, with fluent English.

Responsibilities

• Design and execute downstream experiments; evaluate results.
• Prepare protocols and development reports for projects.
• Lead risk assessments, FMECAs, to support control strategies and filings.
• Collaborate with cross-functional teams and present findings to clients.

Skills

Downstream process development

Statistical analysis

Project coordination

Scientific leadership

Communication skills

Fluent English

Education

Master's degree in Biochemistry or related

PhD in Biochemistry or related

Tools

Python

MATLAB

Statistical software

Job description

Do you want to help customers bring life‑changing biological products to market? Do you thrive in a role where you can learn and grow? Do you value teamwork and love being part of a cross-functional team? If so, this position as a Senior Downstream Scientist in our Late-stage (Phase III) Process Development department is the perfect opportunity for you.

About the Department

The Late-Stage Process Development Department plays a key role in scaling processes from clinical to commercial manufacturing. We consist of three teams of technicians and scientists working across upstream, downstream and analysis. We perform robustness studies, scale-down model qualification, process characterization (PC) studies, and resin lifetime studies. Our PC studies are conducted based on rigorous scientific and statistical principles, and their outcomes feed directly into risk assessments such as FMECAs (Failure Mode, Effects, and Criticality Analysis), which underpin regulatory submissions and control strategies. We collaborate closely with departments such as Early-Stage Process Development, Analytical Method Development, MSAT and Manufacturing.

The Role

You will be responsible for the downstream aspects of development projects working with primarily mammalian, but also microbial, cell lines. Experience with either mammalian or microbial downstream process development is welcomed, provided you have a solid understanding of downstream processes. You will bring scientific leadership through your technical depth, technical decision-making and scientific expertise to drive projects forward. The job includes, among other topics, the following tasks:

• Work with clients and internal project teams to successfully complete projects.
• Coordinate development activities within your own area and participate in development activities across multiple disciplines if needed.
• Design and execute, in collaboration with laboratory technicians, sophisticated, technically challenging experiments, and systematically evaluate results into clear presentations and reports.
• Author technical documentation such as protocols and development reports.
• Contribute to risk assessments, including FMECAs, to support control strategy definition and regulatory filings.
• Provide scientific and technical support to the business.

Experience and Competencies Required

• Master's or PhD in Biochemistry, (Bio)chemical Engineering, Process Technology, or similar, with 5+ years (Master's) or 2+ years (PhD) of relevant industrial experience.
• Proven experience in downstream process development.
• Ability to independently plan and report on complex development studies, including statistical analysis for multiple projects simultaneously.
• Excellent communication and interpersonal skills.
• Fluent in English, written and spoken.

Preferred Qualifications

• Understanding of commercial manufacturing requirements and regulatory aspects (e.g., ICH guidelines and BLA submissions). This is considered an advantage
• This is considered an advantage but is Experience with mechanistic modelling, scientific coding (e.g., Python, MATLAB) and/or liquid-handling robots (e.g., Tecan).

no later than 31 August 2026.

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 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.

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.

If you’re motivated by meaningful impact and ready to join our journey, we invite you to explore our current opportunities!