Scientific Principal, stemcell GMP and Lab

Scientific Principal, stemcell GMP and Lab

Description
We are looking for a self driven experienced Scientific Principal 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.

NNF Cellerator will operate in a novel facility which is part of the Novo Nordisk Foundation’s strategic focus areas in the Life science ecosystem. Cellerator aims to be at the forefront of cell therapy technology and engineering. Cellerator will operate as a contract development and manufacturing organisation for cell-based therapies and will be open to academia as well as industry. The project mission is to accelerate the development of cell-based therapy into clinical trials and to establish a new key unit in the cell therapy ecosystem of Denmark and beyond further supporting the strong growth of this field.

The job: We are seeking a highly skilled Scientific Principal to lead our cell therapy GMP manufacturing and laboratory establishment. In this role, you will develop and lead projects, optimize processes, and ensure compliance with regulatory requirements. You will drive the development and maintenance of quality levels, define facility requirements, and lead project teams.

Key Responsibilities:

• Optimize processes and approaches from both strategic and execution perspectives.
• Ensure compliance with regulatory requirements from relevant health authority regions in relation to GMP manufacture and GMP support functions.
• Support the execution of project deliverables, focusing on GMP manufacture, process validation, and equipment qualification.
• Drive the development and maintenance of a fit-for-purpose quality level in accordance with ATMP and cGMP guidelines.
• Define and write development and manufacturing facility/process requirements and procedures.
• Lead project workstreams and teams of expert consultants to deliver on project timelines.
• Drive audits and inspections within your area of responsibility.
• Set the direction and inspire others with a risk-based approach to QMS implementation and maintenance.
• Collaborate effectively with project colleagues and internal/external stakeholders.

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.

We also imagine that you have:

• Degree in a relevant field (e.g., science or engineering).
• Over 15 years of relevant experience.
• Profound experience with cGMP and regulatory requirements for drug development, preferably from a CDMO or pharma company.
• Experience in a CMO/CDMO environment.
• cGMP manufacturing experience from several drug development projects, including process optimization and decisions on process flow.
• Experience with Risk-Based Approach/ASTMe2500 and adapting QV strategies according to the updated EU GMP Annex.
• Project and SME experience with the establishment of new processes and manufacturing facilities (greenfield and/or rebuilds).
• Strong communication skills, both written and oral, with a proven track record of communicating complex content across organizational levels.
• Advanced IT skills, including collaboration/project tools in MS Office.
• Experience in an international environment and preferably from cross-cultural or global teams.
• Fluent in English, both spoken and written.

As a person you are:

• Quality-conscious and impact-oriented.
• Strong problem-solving and collaborative skills.
• Thrives in a dynamic work environment.
• Independent and capable of making decisions.

Next step
To apply, please send your CV and a short cover letter by clicking the “Apply now” button no later than 7th November 2024.

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.

Hellerup