Senior Downstream Scientist, Manufacturing Product Support

AGC Biologics, Inc.; København; Hybrid; DKK 600,000 - 900,000; Full time

Job summary

AGC Biologics, Inc. is seeking a Senior Downstream Scientist to strengthen our Manufacturing Product Support team in Denmark. You will apply cGMP knowledge to support production, review batch documentation, and lead deviations and corrective actions in a fast-paced setting.

You bring a strong background in downstream processing, write and review GMP documentation, and collaborate across Process Transfer, Validation, QA, and QC to ensure compliant, timely manufacturing.

Qualifications

• Bachelor's or Master's degree in natural or life sciences with at least four years in a cGMP manufacturing setting.
• Experience with GMP documentation and deviation handling in a pharma environment.
• Strong collaboration and communication skills across multiple departments.

Responsibilities

• Create and review Master Production Records and batch documentation.
• Facilitate solutions when issues occur during batch execution.
• Ensure timely deviation closure and root-cause investigations.
• Represent the team in customer meetings and support audits/inspections.

Skills

GMP experience

Downstream processing

cGMP manufacturing

Strong communication

Education

BSc or MSc in natural or life sciences

Tools

Single-use technologies

Aseptic processing

Job description

# Senior Downstream Scientist, Manufacturing Product SupportBe 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 processesWe 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. ## Your Application & Our Interview ProcessSubmit your application no later than Wednesday, October 21.We review applications as they are received and will conduct two rounds of interviews with qualified candidates during weeks 44 to 47, aiming for a start date on January 1. We look forward to hearing from you!