Senior Scientist for Late-Stage Downstream Process Development

AGC Biologics; Søborg; On-site; DKK 700,000 - 1,100,000; Full time

Job summary

AGC Biologics in Copenhagen is seeking an experienced scientist to lead downstream development projects, primarily with mammalian systems and some microbial work. You will drive technical depth, decision-making, and project execution across teams to deliver robust processes.

The role emphasizes scientific leadership, planning complex studies, and producing clear reports while collaborating with Global MSAT, Analytical Method Development, and Manufacturing to support regulatory submissions.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Downstream process development

Statistical analysis

Scientific leadership

Communication skills

Education

Master's or PhD in Biochemistry or related field

Tools

Python

MATLAB

Liquid-handling robots (e.g., Tecan)

Job description

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 Qualifications

• 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 but is


• Experience with mechanistic modelling, scientific coding (e.g., Python, MATLAB) and/or liquid-handling robots (e.g., Tecan).

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.

Location

Copenhagen Site