Senior Pilot Scientist
4 weeks ago
About the Role
We are seeking a highly skilled Senior Pilot Scientist to join our Process Support team at Novo Nordisk's Aseptic Pilot Plant (APP). As a key member of our team, you will provide process support for washing & sterilization, environment, formulation, filling, and manual inspection.
Your primary responsibilities will include:
- Optimization of workflows and processes
- Complex problem solving
- Collaboration and support for our clinical productions
- Collaboration with our colleagues in formulation development on future products
- Review of batch and environmental documentation, instructions, change cases, and deviation management to ensure release of our products for clinical trials
You will work closely with our team to ensure that APP's processes meet the tightened Annex 1 requirements. This will involve the implementation of SAP/PAS-X and a new isolator filling line in the coming years.
Requirements
To succeed in this role, you will have:
- At least a master's degree in pharmacy, chemical engineering, or a similar scientific education
- Preferably relevant work experience in aseptic production in the pharmaceutical industry, preferably in formulation or filling
- Good knowledge of GMP in aseptic production is considered an advantage
- Excellent communication skills in Danish and English
About the Department
At APP, we are in the exciting interface between development and production, with broad contact with many different functions in Novo Nordisk. We manufacture injectable sterile products for clinical trials, primarily phase 1 and 2. Our products vary, but they are all produced according to applicable GMP requirements in an aseptic environment.
We have an exciting everyday life where tasks are challenging and varied. We approach tasks with curiosity and the desire to make a difference. APP is located in Måløv and is part of CMC Drug Product & Analytical Development. The department consists of approximately 90 employees, all on day shift, and includes process areas such as washing & sterilization, formulation, filling, inspection, supply, environment, cleaning, maintenance, and calibration.
Working at Novo Nordisk
We don't wait for change; we drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop; we seize them. From research and development, through to manufacturing, marketing, and sales – we're all working to move the needle on patient care.
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