Senior Scientist for API Development
1 week ago
This is an exciting opportunity to join our dynamic Cell Bank team in API Development as a Senior Scientist or Specialist. In this role, you will play a key part in ensuring the production, storage, and characterization of cell banks meet internal and external quality standards.
You will collaborate with scientists and lab technicians to solve tasks, ensuring adherence to LEAN and GMP principles. Your main responsibilities will include:
- Participating in the preparation for production, storing, and shipping of cell banks according to cGMP.
- Handling change requests to implement changes in existing processes and managing deviations using systematic problem solving.
- Being involved in audits and inspections, addressing Health Authorities' questions, presenting work to them, and managing registrations for different markets.
- Identifying opportunities for process and compliance improvements.
As a Specialist in the Cell Bank, you will be the sole subject matter expert (SME) in Novo Nordisk within the cell banking process. You will act as a key resource for colleagues and management, offering guidance and support on regulatory and quality issues.
About Your Experience
To succeed in this role, you should have a master's degree in cell biology or a related scientific discipline, and 7+ years of relevant experience from the pharmaceutical industry with a proven track record within GMP knowledge.
You should have solid knowledge about cellular biology and culturing/fermentation of mammalian and/or microbial cells, and a strong quality mindset.
You should thrive in an environment with many different tasks in a broad range of areas within the cell banking process and have prior experience in writing documents of good quality and feel comfortable in presenting our work for national and international inspectors.
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