Specialist / Senior Development Scientist

In this job, 371 million people worldwide depend on you to develop the world’s best drugs. Are you ready to take on a new challenge in late-stage API Downstream Development? Join our newly established team at [xxxxx] and contribute to the development and characterization of manufacturing processes for new proteins and peptides? The Position As a Specialist or a Senior Development Scientist you will take part in the transition from early development to late-stage in connection with phase 3 development, perform process characterization, and be involved in transferring these processes to manufacturing development within production supply prior to 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:

Drive activities for shaping and implementing the framework for the process characterisation activities for scalable parameters, including selecting methodologies, tools, and analytical techniques, for the yeast platform projects.

Participate in cross-functional project groups for aligning process characterisation strategies across the CMC API Development area.

Close collaboration with Manufacturing Development in Product Supply to ensure the right stakeholder focus and a smooth tech transfer.

Select and use appropriate analytical tools such as statistical or mechanistic models.

Be innovative in experimental design and optimization, identifying new solutions to increase robustness and/or capacity.

Prepare and review sections for the CMC part of the regulatory submission files.

Here you will develop your scientific expertise, securing task 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, you have:

Experience with process characterization.

Experience in downstream process steps such as chromatography, UF/DF and supporting analytics.

Experience with statistical methods (LHS and/or DoE), and potentially experience with mechanistic mathematical modelling.

Experience with preparation of regulatory documentation.

Good communication skills in English.

An academical background in biochemistry, (bio-)chemical engineering, protein chemistry, or similar.

Your tasks will require that you submerge yourself in scientific details whilst maintaining overview of the project and communicate progress to your stakeholders – so it is important that you thrive in both settings. As a person your positive attitude enables you to work efficiently, whether as a team player or independently, even when dealing with complex tasks, to ensure timely progress. You have excellent communication and collaboration skills that enable you to interact with your many stakeholders from different functions and parts of the organisation. 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 [xxxxx] portfolio and develop our processes in close collaboration with the research and manufacturing units, pilot facilities, and Contract Manufacturing Organisations (CMOs). The department has 90+ employees divided in 8 teams that work together. Working at [xxxxx] 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 Associate Manager Sidsel Marie Nielsen at +[xxxxx]unavailable 17-21 June). Deadline Apply before June,24 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 or CV. To ensure an efficient and fair recruitment 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 [xxxxx] 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.