Senior Downstream Scientist
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Bagsværd
Are you a skilled downstream purification scientist and want to be part of process transfer, implementation and validation activities at our contract manufacturing organizations (CMOs)? Then you could be our new colleague in Bagsværd. Apply now for a life-changing career as a Senior Downstream Scientist!
The position
This role offers a unique opportunity to provide scientific and technical stewardship for downstream processes in synthetic peptide projects, collaborating with Contract Manufacturing Organizations (CMOs) for process transfer and batch execution. Your responsibilities will include evaluating technical designs (e.g. equipment trains, handling, and unit operations) and plans for manufacturing processes performed in collaboration with our CMOs. You will also:
• Participate in cross-organizational groups and take responsibility for assigned deliverables in the technical transfer, batch execution/evaluation, and process validation.
• Act as process, product, and equipment subject matter expert in cross-functional projects to support the timely finalization of scientific and technical documentation, conducted with the right scientific level.
• Provide critical scientific and technical support and troubleshooting for process execution at CMOs, as well as participate in systematic problem solving
• Comment on process/equipment changes and deviations
• Act as an author/co-author, reviewer, and input provider to regulatory registration documents
This job gives you a unique opportunity to work with multiple stakeholders, including Downstream Development, analytical teams, Global Contract Manufacturing (GCM), QA, RA, Sourcing, pilot facilities, production facilities, and external partners.
Some travel activities can be expected. The position does not involve practical work in the laboratory. Qualifications
We would love to hear from you, if you have: • Ph.D. or Master degree within chemical or biochemical sciences, chemical engineering or equivalent.
• Extensive experience with downstream purification of peptide-/protein-based therapeutics within the commercial phase and/or late development phase drug substance manufacturing
• High level of relevant GMP experience and understanding of GMP requirements for drug substance manufacturing
• Experience with scale-up and process transfer to large scale manufacturing is required
• Good technical and practical knowledge of equipment and automation. Good practical understanding of unit operations (at scale) associated with chromatographic separation, filtration techniques and preferably also drying methods
It will be an advantage if you have experience working with CMOs or within a CMO.
On the personal level, you are solution-oriented with strong practical capability to convert theory into practical solutions for technical challenges. You can communicate and collaborate effectively with both internal and external stakeholders across disciplines in development and production. You have a positive attitude with the ability to work efficiently both as a team player and independently on complicated tasks, ensuring timely progress.
About the department
As part of Novo Nordisk’s Product Supply organization. You will be assigned to Manufacturing Development (MDev), a cross-functional area that works at the interface between R&D and full-scale manufacturing with a focus on process understanding, implementation and optimization.
We offer a very interesting and varying job with the opportunity to work with other highly qualified and motivated colleagues in a multidisciplinary project environment.
Working at 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 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 to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Hao Jiang at +45 3448 4222.
Deadline
12th July 2023.
Applications are reviewed on an ongoing basis, so please submit your application as soon as possible. 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 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.
The position
This role offers a unique opportunity to provide scientific and technical stewardship for downstream processes in synthetic peptide projects, collaborating with Contract Manufacturing Organizations (CMOs) for process transfer and batch execution. Your responsibilities will include evaluating technical designs (e.g. equipment trains, handling, and unit operations) and plans for manufacturing processes performed in collaboration with our CMOs. You will also:
• Participate in cross-organizational groups and take responsibility for assigned deliverables in the technical transfer, batch execution/evaluation, and process validation.
• Act as process, product, and equipment subject matter expert in cross-functional projects to support the timely finalization of scientific and technical documentation, conducted with the right scientific level.
• Provide critical scientific and technical support and troubleshooting for process execution at CMOs, as well as participate in systematic problem solving
• Comment on process/equipment changes and deviations
• Act as an author/co-author, reviewer, and input provider to regulatory registration documents
This job gives you a unique opportunity to work with multiple stakeholders, including Downstream Development, analytical teams, Global Contract Manufacturing (GCM), QA, RA, Sourcing, pilot facilities, production facilities, and external partners.
Some travel activities can be expected. The position does not involve practical work in the laboratory. Qualifications
We would love to hear from you, if you have: • Ph.D. or Master degree within chemical or biochemical sciences, chemical engineering or equivalent.
• Extensive experience with downstream purification of peptide-/protein-based therapeutics within the commercial phase and/or late development phase drug substance manufacturing
• High level of relevant GMP experience and understanding of GMP requirements for drug substance manufacturing
• Experience with scale-up and process transfer to large scale manufacturing is required
• Good technical and practical knowledge of equipment and automation. Good practical understanding of unit operations (at scale) associated with chromatographic separation, filtration techniques and preferably also drying methods
It will be an advantage if you have experience working with CMOs or within a CMO.
On the personal level, you are solution-oriented with strong practical capability to convert theory into practical solutions for technical challenges. You can communicate and collaborate effectively with both internal and external stakeholders across disciplines in development and production. You have a positive attitude with the ability to work efficiently both as a team player and independently on complicated tasks, ensuring timely progress.
About the department
As part of Novo Nordisk’s Product Supply organization. You will be assigned to Manufacturing Development (MDev), a cross-functional area that works at the interface between R&D and full-scale manufacturing with a focus on process understanding, implementation and optimization.
We offer a very interesting and varying job with the opportunity to work with other highly qualified and motivated colleagues in a multidisciplinary project environment.
Working at 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 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 to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Hao Jiang at +45 3448 4222.
Deadline
12th July 2023.
Applications are reviewed on an ongoing basis, so please submit your application as soon as possible. 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 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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 7.6.2023, 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.
- Øvrige
- Bagsværd
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