Senior Scientist Peptide Chemistry - Upstream Production & Contract Manufacturing

Are you an expert in peptide chemistry looking to make an impact in synthetic peptide manufacturing? Do you thrive in cross-functional collaborations, ensuring successful process transfers and regulatory compliance? Join us as a Senior Scientist Peptide Chemistry and take the lead in driving innovation, technical excellence, and life-cycle management in peptide manufacturing!

Apply now and start your new journey!

The position

As a Senior Scientist Peptide Chemistry, you will participate in cross-organizational groups, taking responsibility for deliverables in technical transfer, batch execution/evaluation, process validation, and life cycle management.

Acting as process and product owner, you will be serving as a subject matter expert for our synthetic peptide manufacturing platform by Solid Phase Peptide Synthesis (SPPS) for cross-functional projects, ensuring the completion of technical or GMP documentation at the appropriate level for validation, registration, and life-cycle management activities

Your main task will include the following:

• Offer critical scientific and technical support for process execution at CMOs, including troubleshooting and providing input on process and equipment changes and deviations
• Provide technical and scientific stewardship during process transfer, optimization and implementation at CMOs for chemical manufacturing projects, evaluating and challenging proposed technical designs, plans, and process setup
• Support to maintain the validated state of the products, herein regulatory writing, change and deviation management, stability and inspection support
• Collaborate as an author, co-author, reviewer, and input provider for regulatory registration documents

This job gives you 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.

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

Qualifications

We are looking for Peptide Chemistry Senior Scientists who has a strong scientific and/or technical background in peptide synthesis by SPPS and/or knowledge/experience of GMP manufacturing at scale.

The preferable candidate has strong scientific foundation within peptide chemistry. Knowledge of process chemistry (incl. the typical unit operations for manufacturing at scale), process engineering and work experience in cGMP-regulated chemical manufacturing areas are strong advantages. 

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

• Ph.D. or M.Sc. in peptide chemistry, or equivalent
• Experience with chemical manufacturing, preferably for synthetic peptide manufacturing
• Knowledgeable of relevant GMP experience and understanding of GMP requirements for synthetic APIs or bulk pharmaceutical chemicals
• Knowledge of ICH guidelines relevant for API development, manufacturing, and control.  
• Knowledge of the principles of process chemistry, and herein a good understanding of unit operations associated with chemical manufacturing

Experience with scale-up and process transfer to large-scale manufacturing will be seen as a strong advantage, as well as technical knowledge of equipment design and automation and a good understanding of analytical principles, control strategy, and impurity characterization is a strong advantage.

As a person, you possess a solution-oriented mindset with a strong practical capability to convert theoretical knowledge into practical solutions for technical challenges. Your ability to communicate and collaborate effectively with internal and external stakeholders across different disciplines in both development and production is highly valuable.

Furthermore, your positive attitude enables you to work efficiently, whether as a team player or 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

21 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.