Biotechnology Specialist

5 days ago


Copenhagen, Copenhagen, Denmark AGC Biologics Full time

About AGC Biologics

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way.

We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells.

Job Description

The ideal candidate will be responsible for ensuring the highest standards of quality in our production processes. As a key member of our QA or Manufacturing department, you will work closely with cross-functional teams, including QA, QC, and Development, to support the manufacturing of biopharmaceutical products.

Key Responsibilities:

  • Master Production Record Management: Create, review, and maintain Master Production Records to ensure compliance with cGMP regulations.
  • Production Support: Provide on-call/shopfloor support during critical process steps and facilitate solutions during breakdowns in batch execution.
  • Deviation Management: Timely closure of deviations, systematic problem-solving during root cause investigations, and handling other quality documents.
  • Compliance: Establish and maintain procedures to ensure compliance with cGMP regulations.
  • Customer Interaction: Act as a representative in customer meetings and support audits and inspections.
  • Continuous Improvement: Capture learnings and implement continuous improvements to processes.
  • Training: Responsible for project-specific training of technicians.

Areas of Focus

We are looking for scientists to support the following main areas:

  • Microbial Production
  • Mammalian Production
  • Solution Preparation
  • Manufacturing Support
  • Facility & Equipment
  • Material Management


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