Senior Scientist or Specialist to the Cell Banks

3 days ago

Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

About Novo Nordisk A/S

We are a proud life-science company, inspired by life in all its forms and shapes. Our research and development activities focus on creating innovative treatments for patients with chronic diseases across the world.

Our team within Product & Process Development makes a real difference for patients by developing, manufacturing, and distributing drug candidates for clinical trials. We have a strong culture with a "can-do" mindset and work closely with our research and commercial units, as well as our quality assurance organization, regulatory affairs, and QC laboratories.

We are seeking highly skilled professionals to join our cell bank teams, responsible for producing and maintaining cell banks for clinical trials and marketed products under GMP requirements.

The Position

We are looking for two new scientists to be part of our teams: a Senior Scientist and a Specialist. 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.

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.

Key Responsibilities

As a Specialist in the Cell Bank, you will act as the sole subject matter expert (SME) in Novo Nordisk 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.

Your responsibilities will also include:

  • Ensuring that the production, storage, and characterization of cell banks adhere to internal and external quality requirements.
  • Maintaining compliance with GMP standards and addressing 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 of relevant experience from the pharmaceutical industry with a proven track record within GMP knowledge.
  • Have solid knowledge about cellular biology and culturing/fermentation of mammalian and/or microbial cells.
  • Have a strong quality mindset and thrive 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.

About Us

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 the communities we operate in.

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