Senior Bioassay Specialist

2 days ago


Copenhagen, Copenhagen, Denmark AGC Biologics Full time

Are you passionate about ensuring the quality and integrity of biopharmaceutical products? Do you have a strong background in analytical method development and validation?

We are looking for a highly skilled Senior Bioassay Specialist to join our QC General Analytics team at AGC Biologics. In this role, you will be responsible for developing and implementing analytical methods, participating in operational planning, and ensuring all activities follow cGMP guidelines.

The QC Department plays a vital role in maintaining the highest standards of quality and compliance in our production processes. As a Senior Bioassay Specialist, you will work closely with our cross-functional teams to develop and implement bioassays, participate in method validations, and ensure all activities follow cGMP regulations.

Key Responsibilities:

  • Develop and implement analytical methods for QC and research purposes
  • Collaborate with colleagues to develop and implement efficient QC processes
  • Participate in method validations and technical transfers
  • Ensure continuous compliance with cGMP regulations

Requirements:

  • Masters degree in Life Sciences or related field
  • Minimum 3 years of experience in a GMP environment, preferably in QC
  • Experience with method validation, SOP development, and regulatory compliance
  • Excellent communication and teamwork skills

About Us:

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service to our clients and partners. 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.



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