Research Scientist for CMC Analytical Support
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Måløv
We are seeking a highly qualified, motivated and energetic Research Scientist for a position in CMC Analytical Support to drive and support our work to identify and quantify chemical components that could potentially leach from contact materials into the drug product during production and storage.
About the department
CMC Analytical Support consists of four highly skilled teams, and we are 65 colleagues supporting the development organisation with expertise in specialised analytical tasks from late discovery to product launch. Our product pipeline is expanding, and you will have ample opportunities to be part of an innovative and interesting future. The department is part of Chemistry Manufacturing Control Development (CMC Development), located in Måløv. The department is responsible for developing analytical methods, validation, documentation and delivering analytical results for new drug substance, drug product and side chains as well as for raw materials, excipients, and various process related residues and leachables. Furthermore, we are responsible for solid state peptide and protein characterisation including particle characterisation and stability studies. As part of Novo Nordisk’s R&D family, CMC Development makes a real difference for patients with chronic diseases across the world. We develop, manufacture, and distribute drug candidates for non-clinical and clinical trials and represent a strong culture with a “can do” mind-set.
The job
In the “Leachables & Elemental Impurities” team, you will work closely with 13 dedicated colleagues with expertise within a number of analytical techniques including GC-MS, LC-MS and ICP-MS. The tasks in the team vary, but primarily we are responsible for the identification and quantification of compounds that can leach (leachables) or be extracted (extractables) from drug product packaging, medical devices as well as production utensils used during the manufacturing processes. Ad hoc analytical support to the entire organisation is also a major task. As part of the job, you will be responsible for performing extraction studies by preparing test items and executing extractions. We therefore expect you are interested in practical work and will have an active presence in the laboratory. You will further be involved in the analyses of organic compounds and elemental impurities by GC-MS, LC-UV-MS and ICP-MS. Development of methods, troubleshooting as well as daily interaction with our experienced laboratory technicians will be among your tasks. In addition, you will have focus on optimisation and automation of the various procedures and techniques in the laboratory. It is important that you can promote collaboration with other parts of the organisation as the position also requires close interaction with a variety of internal and external stakeholders. Qualifications
You hold a Master of Science degree in chemistry, chemical engineering, pharmaceutical science, or an equivalent discipline. You are in possession of a solid understanding of analytical chemistry and have extensive practical experience with trace analysis by GC-MS, LC-UV-MS and/or ICP-MS. Preferably, you have experience with development and optimization of analytical methods, instrument trouble shooting as well as understanding of organic chemistry. Good knowledge and understanding of documentation required in connection with development of analytical methods for products in clinical development is furthermore important. Knowledge of GMP requirements is an advantage. You have strong communication skills both in spoken and written Danish and English and you find it natural to establish new relationships across teams and departments. We expect you to be open-minded, have a high level of drive and have the ability and willingness to adjust quickly to new situations in a continuously developing environment and to be capable of solving professional as well as business related problems. Furthermore, it is important that you are interested in technical dialogues with the laboratory technicians in the team by active and curious presence in the laboratory.
At Novo Nordisk we use our skills, dedication, and ambition to help people with chronic diseases and change their lives. By working with us you will have the opportunity to do the same in a global business environment.
Contact
For further information, please contact Associate Manager Pia Skov Rath at +45 3079 2856 or Specialist Asger Wisti Nørgaard at + 45 3077 6489 Deadline
Please apply for the position no later than March 1st, 2023. We will review the applications on an ongoing basis, so we encourage you to apply as soon as possible.
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.
About the department
CMC Analytical Support consists of four highly skilled teams, and we are 65 colleagues supporting the development organisation with expertise in specialised analytical tasks from late discovery to product launch. Our product pipeline is expanding, and you will have ample opportunities to be part of an innovative and interesting future. The department is part of Chemistry Manufacturing Control Development (CMC Development), located in Måløv. The department is responsible for developing analytical methods, validation, documentation and delivering analytical results for new drug substance, drug product and side chains as well as for raw materials, excipients, and various process related residues and leachables. Furthermore, we are responsible for solid state peptide and protein characterisation including particle characterisation and stability studies. As part of Novo Nordisk’s R&D family, CMC Development makes a real difference for patients with chronic diseases across the world. We develop, manufacture, and distribute drug candidates for non-clinical and clinical trials and represent a strong culture with a “can do” mind-set.
The job
In the “Leachables & Elemental Impurities” team, you will work closely with 13 dedicated colleagues with expertise within a number of analytical techniques including GC-MS, LC-MS and ICP-MS. The tasks in the team vary, but primarily we are responsible for the identification and quantification of compounds that can leach (leachables) or be extracted (extractables) from drug product packaging, medical devices as well as production utensils used during the manufacturing processes. Ad hoc analytical support to the entire organisation is also a major task. As part of the job, you will be responsible for performing extraction studies by preparing test items and executing extractions. We therefore expect you are interested in practical work and will have an active presence in the laboratory. You will further be involved in the analyses of organic compounds and elemental impurities by GC-MS, LC-UV-MS and ICP-MS. Development of methods, troubleshooting as well as daily interaction with our experienced laboratory technicians will be among your tasks. In addition, you will have focus on optimisation and automation of the various procedures and techniques in the laboratory. It is important that you can promote collaboration with other parts of the organisation as the position also requires close interaction with a variety of internal and external stakeholders. Qualifications
You hold a Master of Science degree in chemistry, chemical engineering, pharmaceutical science, or an equivalent discipline. You are in possession of a solid understanding of analytical chemistry and have extensive practical experience with trace analysis by GC-MS, LC-UV-MS and/or ICP-MS. Preferably, you have experience with development and optimization of analytical methods, instrument trouble shooting as well as understanding of organic chemistry. Good knowledge and understanding of documentation required in connection with development of analytical methods for products in clinical development is furthermore important. Knowledge of GMP requirements is an advantage. You have strong communication skills both in spoken and written Danish and English and you find it natural to establish new relationships across teams and departments. We expect you to be open-minded, have a high level of drive and have the ability and willingness to adjust quickly to new situations in a continuously developing environment and to be capable of solving professional as well as business related problems. Furthermore, it is important that you are interested in technical dialogues with the laboratory technicians in the team by active and curious presence in the laboratory.
At Novo Nordisk we use our skills, dedication, and ambition to help people with chronic diseases and change their lives. By working with us you will have the opportunity to do the same in a global business environment.
Contact
For further information, please contact Associate Manager Pia Skov Rath at +45 3079 2856 or Specialist Asger Wisti Nørgaard at + 45 3077 6489 Deadline
Please apply for the position no later than March 1st, 2023. We will review the applications on an ongoing basis, so we encourage you to apply as soon as possible.
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 23.1.2023, 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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