Senior Scientist for Bioassay Development in CMC
1 month ago
Do you have what it takes to develop Bioassays for oral & injectable biopharmaceutical products during clinical development? Do you thrive in a flexible environment where you change the way we work, possess an inherent curiosity and creativity towards automation and the use of data to improve the development of your assays and processes?
Then you should be our next Senior Scientist in CMC Drug Product & Analytical Development
The Position
As a Senior Scientist you will be responsible for the performance and optimization of analytical Potency assays for specific clinical projects within the Novo Nordisk project portfolio. This means day to day cooperation with laboratory technicians and colleague scientists.
Your responsibilities will include:
Design and prepare the required paperwork for the development and validation of Potency Assays from early to late-stage projects in phase 1-3 (e.g. cell-based bioassay, enzymatic assays and chromogenic assay)
Maintain and update relevant analytical equipment documentation to ensure sufficient cGMP
Work and collaborate in cross organizational project groups across teams and departments in CMC, Research Units and in manufacturing (Product Supply)
Interacting with Health Authorities related to clinical trial applications and Q&A, and a wide variety of internal and external stakeholders, e.g., Production, Regulatory Affairs, Quality Assurance and Analytical Development
You can look forward to using your skills and talent not only in our department but also across Drug Development which covers analysis, drug product development and stability testing within the entire R&D clinical portfolio.
Together with our colleagues, you will also contribute to the on-going optimization of processes and systems with LEAN as the guiding principle.
Qualifications
To succeed in this role, you have:
A master’s degree or PhD within Pharmacy, Chemistry, Biophysics, Engineering of related field of study
Experience with cell-based bioassays development. Preferable in a cGMP environment from the pharmaceutical or biotech industry
Knowledge with documentation to and interaction with Health Authorities
Good communication skills together with an enthusiastic and can-do appearance
As a person you show a strong personal drive that is reflected in your desire to take initiative see things moving forward in a dynamic environment where projects vary, and thereby demands the need for flexibility and skills to organize and drive tasks.
Thus, the position contains good possibilities for improve and develop your project management skills. You are a proactive team player that naturally builds relations to colleagues and stakeholders in the organization with a flair for management. You are positive with a good sense of humor and have curious mind-set.
About the Department
The Department for Bioanalyses is under Chemistry, Manufacturing and Control (CMC) Drug Product & Analytical Development. We support and develop Potency Bioassays for the analysis of drug substance and drug product samples for Novo Nordisk's entire project portfolio in clinical trials, including among others obesity, diabetes, haemophilia, cardiovascular diseases, growth hormone therapy etc. We are characterized by always delivering on time with high quality. The department is divided into 3 teams, and you will be part of Team Bioactivity which consist of 6 scientists and 9 laboratory technicians. The team has great expertise within Bioassays and the work tasks continuously change in pace with new development projects.
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