Are you passionate about working with GMP? Are you energized by having many different responsibilities within a broad spectrum of tasks? And do you want to join a dynamic, highly competent Cell Bank team in API Development, then you may be our new Senior Scientist or Specialist within the cell banks. We are looking for two new scientists so apply today! The position
We are looking for a Senior Scientist and a Specialist to be a part of our teams. The location of the positions (Bagsværd or Hillerød) will be determined during the hiring process and where the competences fit the best but there will be one offering for each cell bank team. As a Senior Scientist, you will collaborate with scientists and lab technicians to solve tasks, ensuring adherence to LEAN and GMP principles. You will oversee the production, storage, and characterization of cell banks, ensuring compliance with internal and external quality standards. You will plan, execute, and report assignments independently and on time, working in cooperation with team colleagues.
Your main tasks will include:
Actively participating in the preparation for production, storing, and shipping of cell banks according to cGMP. Handling change requests to implement changes in existing processes and managing deviations using systematic problem solving. Being involved in audits and inspections, addressing Health Authorities' questions, presenting work to them and managing registrations for different markets. Identifying opportunities for process and compliance improvements. As a Specialist in the Cell Bank, your will act as the sole subject matter expert (SME) in [xxxxx] within the cell banking process. You will act as a key resource for colleagues and management, offering guidance and support on regulatory and quality issues. Moreover, you will represent the NNWay culture in collaboration with stakeholders and team members.
In addition to the various tasks above, your role will include: Ensuring that the production, storage, and characterization of cell banks adhere to internal and external quality requirements. Maintaining compliance with GMP standards and address authority questions, leveraging expertise in Regulatory Affairs (RA) and Quality Assurance (QA). Preparing for audits and inspections, providing insights and recommendations on regulatory and quality matters. Driving new innovations and improvements within the cell bank. Qualifications
To succeed in these roles we expect you to:
Hold a master’s degree within the area of cell biology, fermentation or related scientific discipline. PhD degree is preferred but not a requirement. Have 7+ years relevant experience from pharmaceutical industry with a proven track record within GMP knowledge. Have a solid knowledge about cellular biology and culturing/fermentation of mammalian and/or microbial cells. Have a strong quality mindset and thrives in an environment with many different tasks in a broad range of areas within the cell banking process. Extensive stakeholder management experience complemented by the ability to drive projects with many stakeholders. Have prior experience in writing documents of good quality and feel comfortable in presenting our work for national and international inspectors. On a personal level, you are enthusiastic, committed, and self-motivated. You possess excellent cooperation and communication skills, as your ability to interact with colleagues at various organisational levels is the key in achieving success in both of these positions. You bring a can-do attitude and have the motivation for taking on new challenges and you are a strong team player. You enjoy a working day with very diverse tasks and frequent ad hoc assignments. You possess an analytical mindset and are dedicated to identifying the most effective solutions. About the department
As part of the [xxxxx] PSQIT organisation, Chemistry, Manufacturing and Control (CMC) Product & Process Development makes a real difference for patients with chronic diseases across the world. We develop, manufacture, and distribute drug candidates for clinical trials and have a strong culture with a “can-do” mindset. The cell banks in [xxxxx] consists of two teams. The mammalian cell bank located in Hillerød oversee all cell banks build on the mammalian CHO cell platform. The microbial cell bank located in Bagsværd oversee all cell banks build on the yeast or E. coli cell platforms. Both teams are responsible for the manufacturing and development portfolio in [xxxxx]. Furthermore, the cell banks are responsible for producing and maintaining cell banks for clinical trials and marked products under GMP requirements. We do so in close collaboration with the research and commercial units, as well as our quality assurance organisation, regulatory affairs and QC laboratories. 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 [xxxxx], 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, you are welcome to contact Manager Susan Aagaard (mammalian cell bank) at +[xxxxx]or Manager Jesper Schou (microbial cell bank) at +[xxxxx]. Deadline
6 April 2025
When applying please specify which position and location you are applying for. This will help in selecting the best candidate for the positions. Applications will be reviewed on an ongoing basis. Interviews will be held continuously, so do not hesitate to apply as soon as possible.
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. You have to submit your application in English. 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.
Information og data
Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 13.3.2025, men kan have været deaktiveret og genaktiveret igen.
