Bioprocess Transfer Specialist

3 days ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

Our company, 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.

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.

In this role, you will play a key part in the successful transfer of upstream processes from development to manufacturing or form our clients into AGC Biologics manufacturing, ensuring seamless integration and optimal production.

About the job:

  • You will collaborate with cross-functional teams to facilitate the transfer of upstream processes from development to manufacturing.
  • Lead and execute technology transfer activities, ensuring alignment with project timelines and quality standards.
  • Provide technical expertise in upstream bioprocessing, including cell culture and fermentation, to optimize manufacturing processes.
  • Conduct risk assessments and troubleshoot issues related to technology transfer and manufacturing.
  • Work closely with development teams to gather and document critical process parameters and data for successful transfer.
  • Collaborate with Quality Assurance to ensure compliance with cGMP and other regulatory standards.
  • Participate in process validation activities and support the resolution of deviations or discrepancies.
  • Contribute to the continuous improvement of technology transfer processes and documentation.

Requirements:

  • You have a PhD or M.Sc. within biochemistry, protein chemistry, biotechnology, or a related field.
  • Experience within process development and/or manufacturing within upstream processing.
  • A flexible approach and desire to take on and drive new tasks and responsibilities.
  • Proven experience in upstream bioprocessing and technology transfer within a CDMO or biopharmaceutical environment.
  • Strong understanding of cell culture, fermentation, and bioreactor operations.
  • Experience with process optimization and troubleshooting in a manufacturing setting.
  • Knowledge of regulatory requirements for biopharmaceutical manufacturing (cGMP).
  • Excellent English communication and interpersonal skills.
  • Ability to work collaboratively in a fast-paced and dynamic environment.


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