Bioprocess Transfer Specialist
3 days ago
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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