QC/AD specialist (lead) for Cellerator

QC/AD specialist (lead) for Cellerator

Description
We are looking for a QC/AD lead, to join our team.

Are you passionate about cooperating across organizations and cultures. Do you have an analytical mindset and structured approach? Do you take pride in your great interpersonal skills and collaboration abilities? If so, you might be just the person we are looking for.

The Novo Nordisk Foundation Cellerator is poised to spearhead advancements in the cell therapy ecosystem by establishing and operating a state-of-the-art process development and GMP manufacturing facility. This initiative is integral to fulfilling the Novo Nordisk Foundation’s strategic emphasis on regenerative medicine and the mission is to accelerate the progress of cell-based therapies toward clinical trials within Denmark's cell therapy ecosystem and beyond, thereby fostering significant growth in the field of stem cell-based therapies, for the benefit of patients. The Cellerator will operate as a philanthropic entity dedicated to the development and manufacturing of cell-based therapies, serving both academic institutions and the industry alike.

The Job
You will be given a lot of responsibility from day one. You will be part of an international and purpose-driven working environment with colleagues of diverse backgrounds and perspectives.

Your key tasks will include:

• Subject matter expert for analytical and quality control strategy and method development/implementation.
• Provide analytical guidance and expertise on assay development for quality control during development, manufacture, and release of cell therapy products.
• Accountable for design and equipment for QC and analytical development laboratories.
• Accountable for development of standard operating procedures, study plans, drug substance/drug product specifications, protocols, and method development reports within assay development and quality control.
• Support transfer of analytical test methods (into/out of Cellerator and from development laboratories to GMP performance internally in Cellerator).
• Accountable for securing oversight of collaborators and vendors within assay development and QC.
• Maintain knowledge of current scientific principles and theories and translate these into the most optimal offerings for Cellerator costumers.
• Train other personnel within assay development and QC.
• Management of QC team once the organizational rump up will be completed.
• Ensure regulatory compliance

About you
Due to the novel nature of the Cellerator, curiosity outside of one’s own area is highly valued. You pride yourself with your analytical mindset and structured approach to your tasks. Your former colleagues still talk about your excellent stakeholder management skills, and they miss working with you due to your ability to create both results and good relationships with the people around you. You hold aMSc or PhD in the field of cell therapy, stem cell biology, stem cell engineering or closely related ATMP field.

We also imagine that you have:

• 5+ years of experience within assay development and quality control

• 5+ year of experience working in Good Manufacturing Practice (GMP)

• Vast experience with assay development, method qualification and QC implementation/performance for cell therapy.
• Experience with relevant technologies with emphasis on flow cytometry, functional assays, cell-based assays, Next generation sequencing, ddPCR and other relevant molecular biology technologies.
• Experience with microbiological analyses (sterility, mycoplasma, virus contamination)
• Ability to analyse and interpret complex data.
• Knowledge related to laboratory information system (LIMS) and electronic lab notebook (ELN)
• Experience with cell therapy in a CMC or manufacturing setting.
• Experience in team management is considered a bonus but not required.

You thrive in a changing and dynamic work environment, and in a job that requires you to take initiatives and think out of the box when challenges occur. You have strong collaborative skills and ability to build good relationships to the people around you.

Next step
If you have any questions regarding the position, please contact CBDO, Novo Nordisk Foundation Cellerator Bo Wiinberg, +45 22288291.

To apply, please send your CV and a short cover letter by clicking the “Apply now” button no later than 10 January 2025.

Working at the Novo Nordisk Foundation
We offer a committed and professional workplace in which we emphasize ensuring that our colleagues thrive, are challenged, and have opportunities to develop their potential. A career at the Novo Nordisk Foundation, Cellerator gives you the opportunity to work:

• on important projects that improves people’s health and the sustainability of society and the planet
• with key actors within research and development in Denmark and international
• and as part of a dedicated team that is passionate about creating impact.

About the Novo Nordisk Foundation
Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people’s health and the sustainability of society and the planet. The Foundation’s mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society.

In the coming years, the Foundation will broaden its scope and increase its grants for scientific, humanitarian, and social purposes, including solving the climate crisis and developing tomorrow’s food production. As a consequence, we are a growing organisation, which means new job openings and exciting opportunities for employees to be part of forming the future of the Foundation.

Copenhagen