Mammalian and Microbial Cell Line Specialist
3 days ago
About Novo Nordisk A/S
We are a global biopharmaceutical company dedicated to improving human health through innovative treatments and therapies. Our research and development activities focus on creating novel approaches for treating chronic diseases.
Our Product & Process Development team is responsible for developing, manufacturing, and distributing drug candidates for clinical trials. We 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.
Job Description
As a Senior Scientist or Specialist in the Cell Bank, you will be responsible for overseeing the production, storage, and characterization of cell banks. You will ensure compliance with internal and external quality standards and maintain GMP standards.
You will actively participate in the preparation for production, storing, and shipping of cell banks according to cGMP. You will handle change requests to implement changes in existing processes and manage deviations using systematic problem solving.
As a Specialist, you will act as the sole subject matter expert (SME) in Novo Nordisk within the cell banking process. You will provide guidance and support on regulatory and quality issues and ensure that the production, storage, and characterization of cell banks adhere to internal and external quality requirements.
Responsibilities
Your responsibilities will include:
- Ensuring 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.
Requirements
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 strive to foster a culture of innovation and collaboration. We value our employees and offer opportunities for growth and development.
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Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create AlertSenior Scientist or Specialist to the Cell BanksCategory: ResearchLocation:Bagsværd, Capital Region of Denmark, DKAre 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...
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