Upstream Process Transfer Specialist

1 month ago

Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time
About the Job

AGC Biologics is seeking a highly skilled and experienced Upstream Process Transfer Scientist to join our dynamic team in Copenhagen. As a key member of our Process Transfer Department, you will play a crucial role in the successful transfer of upstream processes from development to manufacturing, ensuring seamless integration and optimal production.

Key Responsibilities
  • 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
  • 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.
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. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice.

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