Downstream Scientist, Manufacturing Product Support

AGC Biologics; Søborg; On-site; DKK 600,000 - 900,000; Full time

Job summary

AGC Biologics in Søborg (Copenhagen area) is seeking a Downstream Scientist to support production by reviewing Master Production Records and guiding on-line batch execution to ensure timely, error-free manufacture.

The role requires a BSc/MSc in life sciences and 2+ years’ cGMP experience in pharmaceutical manufacturing, with GMP documentation, deviations, CAPAs, and single-use/aseptic processing familiarity. Strong cross-functional collaboration is essential.

Qualifications

• BSc or MSc in life sciences is preferred.
• 2+ years in a manufacturing team operating under cGMP in the pharmaceutical industry.
• Experience writing, reviewing and approving GMP documentation, including deviations and CAPAs.

Responsibilities

• Support production by creating and reviewing Master Production Records.
• Facilitate solutions when break-downs occur during batch execution.
• Ensure timely deviation closure and root cause investigations.
• Participate in audits, customer meetings, and implementing process improvements.

Skills

GMP knowledge

cGMP manufacturing

Troubleshooting

Communication

Cross-functional teamwork

Education

BSc/MSc in life sciences

Tools

Single-use systems

Aseptic processing

Job description

As a CDMO, AGC Biologics manufactures drugs for a variety of different customers. Depending on the customer needs, this can be for drugs ranging from development to clinical and commercial production. Right now, you have the opportunity to join the Manufacturing Product Support department as a Downstream Scientist in one of our commercial teams! If you enjoy having fun at work and bring good energy to a team, this job opportunity may be a perfect match for you!

In this position you can utilize your technical problem-solving skills, process understanding, and experience from a cGMP environment! We offer you an opportunity for further growth by joining a team with in depth knowledge of the product specific requirements and a lot of inter-departmental collaboration. You will be part of owning batch documentation, review and deviation handling and we are proud to support the production line with an error-free and timely production execution.

Grow your downstream skills in Manufacturing Product Support!

As a Downstream Scientist, you will be responsible for support to the production. You will be accountable for creating and responsible for reviewing the Master Production Record. Whenever a break-down during batch execution occurs, you will be responsible for facilitating solutions on how to proceed. You will be accountable for timely deviation closure (incl. systematic problem-solving during root cause investigation), as well as other quality documents. Over time, you will also be exposed to additional responsibilities such as being customer meeting representative, supporting our audits and inspections, capturing learnings and implement cont. improvements to process etc.

"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

Our team covers a duty phone, so you will be on call/shopfloor scientist to ensure on the line support during critical process steps. You can expect to be on call approximately 24 hours three times a month.

Your experience with GMP & downstream processes is key!

As a Downstream Scientist, we value your scientific knowledge, so bringing a BSc or MSc from natural or life science related fields is preferred. Your previous experience, 2 years or more, working in a manufacturing team operating under cGMP preferably within the pharmaceutical industry comes well into play in our environment. It is an advantage but not a requirement that you have been working in commercial GMP manufacturing. We are very keen on welcoming a new team member who has been working in a similar production support role with downstream process experience. Preferably, you have experience writing, reviewing and approving GMP documentation, and we appreciate if you are already trained in deviations and have a basic understanding of CRs, CAPAs etc. It is a plus if you have experience with operations of single-use technologies and aseptic processing.

What matters to the team is that you have strong communication skills because it helps in your interaction with internal and external stakeholders. You will be utilizing your skills in coordinating multi-departmental tasks and deliverables (interaction with Process Transfer, Process Validation, Engineering, QA, QC, etc.). Further, we are looking for someone with demonstrated experience in leading troubleshooting efforts. People are self-motivated, organized and proactive, so we expect that you recognize yourself as such.

Your application & our interview process

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.

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