Senior Scientist in Late-stage Downstream Development

Are you ready to shape the future of API process characterization in late-stage downstream development? Do you have the expertise to drive innovative solutions and ensure seamless tech transfer in a high-impact role? If so, consider joining us as a Senior Scientist in late-stage downstream development in CMC Development & Scaling.  
 

Apply today and join us for a life-changing career!

The position
In this role, you will take part in the transition to late-stage development in connection with phase 3 development with an eye for the later commercial process and scale. 

Your main task will be characterization of API downstream processes, and you will be involved in transferring these processes to manufacturing, science and technology (MSAT) within production supply, who will perform final process validation. Your role will be crucial in establishing the structure and framework for how process characterization of our API processes will be handled. You will also be responsible for planning, executing, and analysing laboratory experiments to develop robust and scalable purification processes.

The main tasks will be to:

• Participate in shaping and implementing the framework for the API process characterization activities, including selecting methodologies, tools, and analytical techniques and communicating this within our area.
• Participate in cross-functional project groups for aligning process characterization strategies across the CMC API Development & Scaling area.
• Close collaboration with MSAT in Product Supply to ensure a mutual understanding of the process and scale with our stakeholders and a smooth tech transfer.
• Select and use appropriate analytical tools such as statistical or mechanistic models.
• Be innovative in experimental design and optimization of API processes and workflows, identifying new solutions to increase robustness and/or capacity in the late-stage projects.
• Prepare and review sections for the CMC part of the regulatory submission files.
• Reporting and communication of your results to your peers, project and line management and our stakeholders.

Here, you will develop your scientific expertise and knowledge sharing in close collaboration with highly talented and motivated colleagues. You will become part of a department with an informal working environment with focus on well-being and flexibility in workplace and hours.

Qualifications
To succeed in this role, we expect you to have:

• A Master’s degree in biochemistry, (bio-)chemical engineering, protein chemistry, or similar, along with some relevant industrial work experience. 
• A positive mindset. 
• A systematic approach and a drive to finalize your tasks in time.
• Good collaboration skills and good communication skills in English.

It is an advantage that you have: 

• Experience with process characterization.
• Experience in downstream process steps such as purification by chromatography, tangential flow filtration for UF/DF, modifications and supporting analytics.
• Experience with statistical methods (LHS and/or DoE), and potentially experience with mechanistic mathematical modelling and/or working with large data sets is an advantage.
• Experience with preparation of regulatory documentation.

As a person your positive attitude enables you to work efficiently, whether as a team player or independently. You have excellent communication and collaboration skills that enable you to interact with our many stakeholders from different functions and parts of the organisation.
 

Your tasks will require that you submerge yourself in scientific details, whilst maintaining overview of the project and communicate the progress to our stakeholders – so it is important that you thrive in both settings. 

About the department
The job is placed in the department Downstream Development in CMC Development & Scaling, located in Bagsværd. Our main responsibility is to develop downstream manufacturing processes for new Active Pharmaceutical Ingredients (APIs) used in clinical trials and preparations for market production. We cover projects across the entire Novo Nordisk portfolio and develop our processes in close collaboration with the research and commercial manufacturing facilities, pilot facilities, and Contract Manufacturing Organisations (CMOs). The department has 100+ employees divided in 8 teams that work together.

Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We are 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 are all here - to ensure that people can lead a life independent of chronic disease.

Contact 
For further information, please contact Associate Manager Sidsel Marie Nielsen at +45 30791390.

Deadline
1 December 2024

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 / CV. 

We look forward to reading your application, and we will review applications received on an ongoing basis, so do not hesitate to apply as soon as possible.
 

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.