Imagine making a difference for millions of people living with a chronic disease while growing your career in a very successful global healthcare company.

In Chemical Development, we are responsible for developing the synthetic processes required to produce the active pharmaceutical ingredients (APIs) for Novo Nordisk's new and innovative product portfolio. These processes encompass chemical modification of recombinantly-produced proteins, as well as chemical synthesis of peptides, oligonucleotides, small molecules and novel excipients. Our work spans various stages of development, from clinical trials to commercial manufacturing. As we expand into more synthetic API production platforms, Chemical Development is becoming an increasingly significant growth area for Novo Nordisk.

We are looking for people with a background in organic synthetic chemistry, chemical engineering, or related subjects. Experience in drug substance process development or API manufacturing under GMP is valued, but not a requirement, as we are looking for talents with a wide range of seniorities and competencies. Being science-driven, pro-active, structured and having good communication skills are key to succeed in our team.

In Chemical Development, we receive the new clinical candidates from our research organisation and develop the first process for scale-up manufacturing, together with our colleagues from upstream (recombinant protein production) and downstream (purification and drying) development. For production of the first GMP batch for phase 1 clinical testing, we work closely with our colleagues in the various pilot plants and ultimately run the process in their facilities.

Since the production of all necessary chemical building blocks cannot be performed internally, we have established a strong network of Contract Development and Manufacturing Organisations (CDMOs) around the globe, which assist us in various stages of the manufacturing process.

If the clinical candidates succeed and reach phase 3 development stage, project responsibility is transferred internally from our early-stage team to our late-stage team which is specialized in maturing processes for commercial manufacturing

Collaboration is key to succeed in our area. Therefore, a large part of our time is spent  working with internal colleagues in research, upstream and downstream development, our pilot Plants, analytical chemistry, our project management organisation, our drug product organisation and QA, as well as with external collaborators like our CDMOs, assisted by our outsourcing organisation.

Here, we have to be at our best to communicate and collaborate efficiently. We are deeply committed to nurturing a collaborative and enthusiastic working-environment, where we can challenge ourselves and each other. The development of our employees with interesting and new tasks and new technologies is one of our focus areas, as well as having a social work environment with a lot of possible activities.

The lifetime of development projects in our area spans over many years, during which we continuously improve and mature the processes that we ultimately deliver to our commercial organization to support our purpose of driving change for people living with serious chronic diseases.

Chemical Development contributes to the delivery of chemical and semi-recombinant APIs, including synthetic peptides, oligonucleotides, small molecules, and novel excipients, as well as the delivery of chemical intermediates for the modification of recombinant peptides and proteins. We are also responsible for radioactive labelling of our APIs with 3H, 14C and 125I for Immunogenicity assessment and DMPK studies. The department is involved in early non-clinical projects up to Phase 3 GMP-manufacturing, process validation and transfer to commercial production. The aim is to develop robust, technically feasible and economical processes, whilst minimising the environmental impact. This is enabled by new technologies being pursued both internally and externally through collaborations with business partners and academia.

Currently the area consists of two departments and three teams:

  • External Chemical Development oversees process development of development projects in the later clinical phases and up to validation for commercial production for synthetic processes when the projects are outsourced. The department will consist of two teams in Denmark and one team in Boston, US.
  • Emerging Technologies API Manufacturing Development oversees our synthetic processes for commercial production of synthetic peptides, small molecules, and oligonucleotides as well as some of the building blocks used in semi-recombinant API processes.
  • Chemical Development 1 & 3, these two teams are lab active and oversee process development of development projects from lead candidate selection and up to validation for commercial production for synthetic processes when run internally.
  • Isotope Chemistry is a lab active team in charge of radioactive labelling of our APIs with 3H, 14C and 125I.

Our team in Chemical Development currently consists of 80+ chemists and laboratory technicians, and we have access to state-of-the-art chemistry laboratory facilities in Bagsværd (DK) and offices in Boston (USA). Our facilities enable us to support various types of work, including isotope chemistry, scale-up productions, and standard process development.

The main objective of CMC Chemical Development is to deliver material to support clinical phase 1-3 trials and scale-up and mature the process for process validation and transfer to product supply. However, in addition to these activities CMC Chemical Development also operate within green chemistry, technology and external collaborations by:

  • Reduce the environmental impact of our processes.
  • Meet requirements from the environmental authorities.
  • Ensure that we are technically capable of meeting demands.
  • Increase capacity/productivity
  • Reduce the cost

We meet these goals by initiating projects in various ways:

  • Developing digital tools that will aid colleagues in reaching goals.
  • In-house chemical development by MSc/PhD students, Postdocs and Scientists
  • Outsourcing projects to contract research organisations.
  • Engaging in scientific collaborations with contract manufacturing organisations and/or universities
  • Collaborating with other pharma companies through organisations such as the American Chemical Society Green Chemistry Institute, the IQ consortium, Innovative Health Initiatives PharmEco etc.

Projects cover the full spectrum of technological readiness levels from basic process research to develop green manufacturing methods for the future (long-term high-risk projects), to short- to mid-term solutions to current manufacturing challenges.