Cell Therapy Scientist - Raw Materials
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Do you want to play a significant role in developing protocols for stem cell derived cell therapy for clinical use? Do you want to be part of a team that ensures suitable and compliant raw materials for cutting edge cell therapies? If your answer is positive, then this job will be just right for you. Apply Today and come join us! The Position As a Scientist in Cell Therapy Raw Materials, you will be responsible to ensure the appropriate quality of raw materials and other GMP materials for Advanced Therapeutic Medicinal Products (Cell therapy) manufacture. Examples of cell therapy raw materials are culture media, enzymes and single use plastic materials. Examples of GMP materials are excipients and primary packing systems, needed for formulation and device delivery, as well as storage and transportation of the final products. You will support the CT projects on getting the Raw material strategy right, coordinate the exchange of not suitable raw materials by higher quality alternatives in the cell production process in our development lab. Furthermore, you will provide scientific support and coordinate the GMP raw materials qualification, following internal procedures and regulatory guidelines, and work closely with the Novo Nordisk CMC raw materials team, analytical departments, virologists, microbiologists and QA. Few key tasks will include but are not limited to: Understanding and communicating about the use and criticality of the raw materials in the specific processes, risk assessment and document review Ensuring the appropriate use of raw materials in the GMP production of cell therapy products and closely interacting with the manufacturing unit and our partners all around the world Supporting the regulatory writing of the clinical trial application for the cell therapy projects to reach to the patients worldwide Identifying and documenting raw materials and project-related challenges and working on finding solutions with project members and other stakeholders within and outside of Cell therapy Qualifications Preferably, you must hold a master degree in life sciences, e.g., biology, biochemistry, pharmaceutical sciences or other relevant discipline combined with 3-5 years relevant experience. Alternatively, you hold a PhD within a relevant area and ideally some years of relevant experience. The ideal candidate has experience within the following: Stem cell culturing and differentiation Screening and testing raw materials for GMP production Experience with container closure systems for cell therapy products Knowledge of the regulatory framework of Advanced therapeutic medicinal products (ATMPs) Previous experience or relevant courses within project management will be an asset Proficiency in English, both written and spoken As a person, you are open-minded and a good communicator by nature. You have a high level of energy that drives you and inspires your colleagues. You thrive in a changing and dynamic work environment and in a job that requires you to take initiatives and think out of the box when challenges occur. You are a true team-player who enjoys working in close collaboration with colleagues in and out of the laboratory. About the department The department Cell Therapy Raw Materials is part of Novo Nordisk’s Cell Therapy R&D unit, where we develop novel cell replacement therapies for the treatment of serious chronic diseases, together with the rest of Novo Nordisk and with external collaborators. Our department focuses on the development of manufacturing processes, formulating the cell therapy product and developing related analysis and setting up clinical supplies for our upcoming clinical trials. Diabetes mellitus type 1, Parkinson’s disease and chronic heart failure are only some of the indications we are currently working on. You will join an international and dedicated group of around 90 employees, including scientists, technical coordinators, laboratory technicians and student workers who are part of the CMC and Manufacturing business area in Cell Therapy R&D. We truly believe that cell therapies will make a difference in the lives of patients suffering from chronic diseases. If this awakens your interest, please apply and support us in progressing our cell therapy projects into the clinic. Working in Novo Nordisk 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. Contact For further information, please contact Ida Kjær, Department Manager at +45 3077 7010. Deadline 28 December 2023. Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified. 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.
Information og data
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 1.12.2023, 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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