Senior Scientist for late phase Bioassay Development in CMC
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Do you have what it takes to develop Bioassays for oral & injectable biopharmaceutical products during clinical development? Do you thrive in a high paced environment where you change the way we work, possess an inherent curiosity 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 & Analysis 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 for late-stage projects to phase 3 and to some extend for phase 1 and 2 (e.g. cell-based bioassay, enzymatic assays and chromogenic assay)
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
5 years of experience with cell-based bioassays development in a cGMP environment from the pharmaceutical or biotech industry
Experience with documentation to and interaction with Health Authorities
Good communication skills in English
As a person you are 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. 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 & Analysis 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 7 chemists and 9 laboratory technicians. The team has great expertise within Bioassays and the work tasks continuously change in pace with new development projects. Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. Contact For further information, please contact Associate Manager Nikolaj Nielsen at +45 3075 4662 or Senior Scientist Jette Christensen at + 45 3079 8601. Deadline Apply before January, 10 2023. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
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Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 13.12.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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