Novo Nordisk
Mammalian Cell Bank Scientist
Are you passionate about working with GMP? Are you energized by having many different responsibilities within a broad spectrum of tasks? And do you want to join a dynamic, highly competent Cell Bank team in API Development?
Then you may be our new Scientist within Mammalian Cell Bank production. Apply today!
The position
The position, Mammalian Cell Bank Scientist, is anchored in CMC API Development in Hillerød. You will be part of the team with 6 great colleagues. The department is responsible for manufacturing and controls new drug substance candidates for the development portfolio in Novo Nordisk. The Cell Bank team is furthermore responsible for producing and maintaining cell banks for clinical trials and marketed products under GMP requirements. We do so in close collaboration with the research unit as well as our quality assurance organisation, regulatory affairs and QC laboratories.
As Cell Bank Scientist your job will be to include many different tasks within a broad area of the cell banking process, which you will solve together with other scientists and laboratory technicians. The LEAN and GMP principles will be a corner stone in your workday.
Your tasks will include:
Responsibility for documentation to ensure that the production, storage, and characterisation of our cell banks are following internal and external quality requirements.
Be an active player in the work regarding preparation for production, storing and shipping of cell bank and maintaining cell banks according to cGMP.
Handling change requests to implement changes in existing processes and handle deviations where systematic problem solving is used.
Because we produce and maintain the inoculation material for all Novo Nordisk products produced by mammalian cells, you will be involved in audits and inspections as well as questions from the Health Authorities and registrations for different markets. We expect you to be motivated by planning, executing, and reporting assignments independently, timely and in cooperation with your team colleagues. We work with many stakeholders and present our work for inspectors, therefore, it is important that you are a strong communicator. In addition, you will be responsible for identifying opportunities for improving processes and compliance.
Qualifications
To thrive in this role you have:
Master’s degree with 5+ years relevant experience from pharmaceutical industry with a proven track record within GMP knowledge.
Solid knowledge about cellular biology and culturing of mammalian cells.
Strong quality mindset and thrives in an environment with many different tasks in a broad range of areas within the cell banking process.
Analytical mindset and find the best solutions.
Ability to drive projects with many stakeholders.
Experience writing documents of good quality and feel comfortable in presenting our work for national and international inspectors.
You enjoy a working day with very diverse tasks and frequent ad hoc assignments.
PhD degree within the area of cell biology will be preferred but not a requirement.
On a personal level, you are enthusiastic, committed, and self-motivated. You possess excellent cooperation and communication skills, as your ability to interact with colleagues at various organisational levels is the key in achieving success in this position. You bring a can-do attitude and have the motivation for taking on new challenges and you are a strong team player.
Husk at skrive i din ansøgning, at du så jobbet hos Ofir