Senior Downstream Scientist, Manufacturing Product Support

AGC Biologics; København; Presencial; DKK 600.000 - 800.000; Jornada completa

Descripción de la vacante

AGC Biologics is seeking a Senior Downstream Scientist to join the Manufacturing Product Support team in a Danish site. The role focuses on supporting production with cGMP governance, ensuring timely deviation handling, and maintaining quality documentation while collaborating across Process Transfer, Validation, Engineering, QA and QC.

The ideal candidate will bring strong downstream process knowledge, hands-on GMP experience, and a proactive approach to troubleshooting and continuous

Formación

• Requires experience in writing, reviewing and approving GMP documentation.
• Experience in cGMP manufacturing environment is preferred.
• Strong communication and collaboration skills across multiple departments.

Responsabilidades

• Create and review Master Production Records and batch documentation.
• Facilitate solutions when issues or breakdowns occur during batch execution.
• Close deviations timely with root cause investigations and CAPAs.
• Lead troubleshooting and represent the team in customer meetings and audits.

Conocimientos

GMP experience

Downstream processing

Documentation write/review

Root cause analysis

On-call support

Educación

BSc/MSc life sciences

Herramientas

Single-use technologies

Aseptic processing

Descripción del empleo

Be part of a team supporting commercial manufacturing at AGC Biologics!

As a CDMO, AGC Biologics manufactures drugs for a variety of customers, supporting products from development through clinical and commercial production.

Now, you have the opportunity to join our Manufacturing Product Support department as a Downstream Scientist in one of our commercial teams. If you enjoy working in a team with great energy, strong collaboration, and room for having fun, this could be a great match for you!

In this role, you will bring your technical problem-solving skills, process understanding, and cGMP experience into a team with in-depth knowledge of product-specific requirements and close collaboration across departments. You will contribute to batch documentation, review, and deviation handling, supporting error‑free and timely production execution while continuing to develop your skills.

The Role: Grow your downstream skills in Manufacturing Product Support

As a Senior Downstream Scientist, you will play an important role in supporting production and ensuring that manufacturing activities are executed efficiently and in compliance with quality requirements.

Your Key Responsibilities Will Include

• Creating and reviewing Master Production Records and supporting batch documentation.
• Facilitating solutions when issues or breakdowns occur during batch execution.
• Ensuring timely deviation closure, including systematic problem-solving and root cause investigations, as well as handling other quality documentation.
• Over time, taking on additional responsibilities such as representing the team in customer meetings, supporting audits and inspections, capturing learnings, and implementing continuous process improvements.

Our team works closely together to support production, combining technical expertise with a positive and collaborative working environment.

"What makes our team a fantastic and unique place to be is our teamwork. We are sharing such a good spirit and high energy - and having fun!"

Nezrab Sedighi, Manager of Manufacturing Product Support

As part of the role, you will also participate in our duty phone arrangement, providing on‑call and shopfloor scientist support during critical process steps. You can expect to be on call for approximately 24 hours, three times a month.

What You Bring: Experience with GMP and downstream processes

We are looking for a Senior Downstream Scientist with a strong scientific background and hands‑on experience from a cGMP manufacturing environment.

A BSc or MSc in natural or life sciences is preferred, along with at least four years of experience working in a manufacturing team operating under cGMP, preferably within the pharmaceutical industry.

Experience from commercial GMP manufacturing is an advantage, but not a requirement. We particularly value experience from a similar production support role involving downstream processes.

You bring experience in writing, reviewing, and approving GMP documentation and are familiar with deviations, CR, and CAPAs. Experience with single‑use technologies, aseptic processing, or customer‑facing responsibilities will be considered an advantage.

Beyond your technical experience, strong communication and collaboration skills are important. You will work with both internal and external stakeholders, coordinating tasks and deliverables across departments such as Process Transfer, Process Validation, Engineering, QA, and QC.

We are also looking for someone with demonstrated experience in leading troubleshooting efforts who brings a self‑motivated, organized, and proactive approach to their work.

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.