Senior Downstream Scientist, Manufacturing Product Support

AGC Biologics A/S; København; On-site; DKK 650,000 - 850,000; Full time

Job summary

AGC Biologics Søborg site is seeking a Senior Downstream Scientist to join Manufacturing Product Support. You will help ensure efficient, compliant production in a cGMP environment and support batch documentation, deviations, and continuous improvement.

The role involves collaborating with Process Transfer, Validation, QA, and QC, taking on additional responsibilities such as customer meetings and audits over time, and participating in on-call support (~24 h/month).

Qualifications

• GMP and downstream processes experience.
• BSc or MSc in natural or life sciences with at least four years in a cGMP manufacturing environment.
• Experience in commercial GMP manufacturing is advantageous.
• Experience writing, reviewing, and approving GMP documentation and deviations, CRs and CAPAs.
• Experience in downstream production support roles.

Responsibilities

• Create and review Master Production Records and batch documentation.
• Facilitate solutions when issues arise during batch execution.
• Ensure timely deviation closure with root cause investigations and CAPAs.
• Represent the team in customer meetings and support audits/inspections when needed.
• Capture learnings and implement continuous process improvements.

Skills

GMP experience

Downstream processes

Communication skills

Problem solving

Team collaboration

Education

BSc or MSc in natural or life sciences

Tools

Single-use technologies

Aseptic processing

Job description

Senior Downstream Scientist, Manufacturing Product Support

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.

Key Responsibilities

• 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.


• 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.


• Experience from a similar production support role involving downstream processes.


• Experience in writing, reviewing, and approving GMP documentation and familiarity with deviations, CR, and CAPAs.


• Experience with single‑use technologies, aseptic processing, or customer‑facing responsibilities will be considered an advantage.


• Strong communication and collaboration skills; 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.


• Demonstrated experience in leading troubleshooting efforts; you bring a self‑motivated, organized, and proactive approach to your 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. 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!