Senior Development Scientist, Downstream Purification of Synthetic Peptides & Contract Manufacturing

Are you passionate about scientific and technical excellence in downstream processing? Do you want to play a key role in process transfer and batch execution at CMOs for synthetic peptide projects? Then apply now and join us as a Senior Downstream Scientist and collaborate with cross-functional teams to drive innovation and ensure manufacturing success!

The position
As a Senior Downstream Scientist, you will provide scientific and technical stewardship for the downstream process during process transfer and batch execution at CMOs (Contract Manufacturing Organizations) for synthetic peptide projects. Common tasks include the evaluation of proposed technical designs (e.g. equipment trains, handling and unit operations) and plans for manufacturing processes performed in collaboration with our CMOs.

Your main task will include the following:

• 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
• Comment on process/equipment changes and deviations
• Participate in systematic problem solving

Furthermore, you will collaborate 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. 

Travel activities are to be expected, approximately 20%. The position does not involve practical work in the laboratory.

Qualifications
We are looking for a Senior Development Scientist who has a strong scientific and technical background within downstream purification and drying processes for pharmaceutical manufacturing at scale.

To succeed in the role, we expect that you have some of the below qualification and is eager to learn any remaining required skillset:

• Masters’ degree or Ph.D. within chemical or biochemical sciences, chemical engineering or equivalent
• Extensive experience with downstream purification of peptide-/protein-based therapeutics within 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, paired with understanding of unit operations (at scale) associated with chromatographic separation, filtration techniques and preferably also drying methods

Experience working with CMOs or within a CMO will be seen as an advantage.

On a personal level, you are a solution-oriented with strong practical capability to convert theory into practical solutions for technical challenges. You have the ability to communicate and collaborate effectively with both internal and external stakeholders across disciplines in development and production, showcasing 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 Emerging Technologies API Manufacturing Science and Technology (ET API MSAT). We work at the interface between CMC and full-scale manufacturing with a focus on process understanding, implementation, optimization, and life cycle management. 

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
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 Dan Killander +45 3075 1092

Deadline
20 February 2025

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.