Are you a skilled process engineer with experience in organic synthesis and/or GMP chemical manufacturing? Do you want to be involved in technology transfers, process validations, and life cycle management activities at our contract manufacturing organizations? If so, you could be our new colleague in Bagsværd. Apply now and start your new journey!
The Position
As a Development Engineer with a strong scientific and/or technical background in organic synthesis and/or GMP manufacturing of chemical entities at scale, your responsibilities will include:
· Participating in projects by lending your expertise on chemical engineering challenges, equipment use, and process improvements.
· Contributing to cross-organizational teams and taking responsibility for deliverables related to technical transfers, batch execution/evaluation, process validation, and life cycle management.
· Acting as a process owner, serving as a subject matter expert in chemical engineering for cross-functional projects. You will ensure the completion of technical and GMP documentation at the appropriate level for validation, registration, and life cycle management activities.
· Providing critical scientific and technical support for process execution at CMOs, including troubleshooting and evaluating process and equipment changes and deviations.
· Offering technical and scientific stewardship during process transfer, optimization, and implementation at CMOs for chemical manufacturing projects. This includes assessing proposed technical designs, plans, and process setups.
· Supporting the maintenance of validated product states, including regulatory writing, change and deviation management, stability assessments, and inspection support.
· Collaborating as an author, co-author, reviewer, and contributor for regulatory registration documents.
This role offers a unique opportunity to work with multiple stakeholders, including Late-Stage Development, Analytical Functions, Global Contract Manufacturing (GCM), QA, RA, Sourcing, pilot facilities, production facilities, and external partners.
The position involves approximately 20% travel but does not require laboratory work.
Qualifications
To succeed in this role, we expect you to have:
- M.Sc. or PhD in Chemical Engineering or Biochemical Engineering.
- A minimum of 3 years of work experience in the industry.
- Experience in chemical manufacturing, preferably at pilot plants or in commercial manufacturing.
- GMP experience.
- Knowledge of ICH guidelines relevant to API development, manufacturing, and control.
- Strong understanding of process chemistry principles, including unit operations associated with chemical manufacturing.
- Experience with scale-up and process transfer to large-scale manufacturing (a strong advantage).
- Technical knowledge of equipment design, automation, and dimensioning, with a good understanding of analytical principles, control strategies, and impurity characterization (a strong advantage).
As a person, you have a solution-oriented mindset and the ability to translate theoretical knowledge into practical solutions for technical challenges. Your strong communication and collaboration skills enable you to work effectively with internal and external stakeholders across different disciplines in both development and production. Whether working as part of a team or independently, your positive attitude and structured approach ensure timely progress on complex tasks.
About the Department
As part of Novo Nordisk’s Product Supply organization, you will join Emerging Technologies API Manufacturing Science and Technology (ET API MSAT)—a cross-functional area within Product Supply. We work at the interface between CMC and full-scale manufacturing, focusing on process understanding, implementation, optimization, and life cycle management.
We offer an exciting and dynamic role with opportunities to collaborate with highly skilled and motivated colleagues in a multidisciplinary project environment.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change—we drive it. As a dynamic company in an ever-evolving industry, we understand that what brought us here won’t necessarily take us forward. That’s why we embrace innovation and experimentation, striving for excellence without fixating on perfection.
From research and development to manufacturing, marketing, and sales, we are all working together to improve patient care. We seize every opportunity to develop and grow, ensuring we stay at the forefront of our industry.
Contact
For further information, please contact Dan Killander at +45 3075 1092.
Deadline
March, 2. 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 to 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.