GMP Material Scientist for Raw Material qualification

14 hours ago

Gladsaxe Kommune, Denmark Novo Nordisk AS Full time

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GMP Material Scientist for Raw Material qualification

Category: Manufacturing

Location: Søborg, Capital Region of Denmark, DK

Are you ready for a career in the pharmaceutical industry and join a growing area taking part in the development of the future Novo Nordisk product pipeline? Are you looking for an opportunity to apply and develop your skills within raw materials for GMP production, process, project & stakeholder management? And do you thrive working with high complexity tasks and improvement projects focusing on digital solutions and automated processes?

If yes, then we have the right challenge for you within the expanding GMP Raw Materials team in CMC API Process Operations as our new Development Scientist for Raw Material qualification. Come join us in helping more than forty million patients worldwide.

The Position

In CMC API Process Operations we are a dedicated team ensuring safe and compliant GMP materials for innovative treatments, including Advanced therapy medicinal products (ATMPs) for GMP production to all of Novo Nordisk clinical trials globally.

As Material Responsible you will ensure the suitability of all materials for GMP production to clinical trials from the entire Novo Nordisk development portfolio supporting different technologies and production platforms. We are divided into two teams with different areas of responsibilities.

You will be our representative in the CMC project teams and bridge between project management, process development, CMC API Pilot facilities in both the early development as well as late-stage development. Your stakeholders will also include multiple different experts within Novo Nordisk, such as chemists, virologists, and microbiologists.

Your responsibilities will include but not be limited to:

  • GMP material Qualification of different types of materials (raw materials, consumables, intermediates) including Setting the internal release specification for the warehouse and quality control (QC).
  • Close contact and collaboration with various external stakeholders such as material suppliers, logistics services, etc., to obtain sufficient knowledge to ensure patient safety, GMP, and GDP compliance.
  • Collaboration with internal stakeholders to ensure proper scientific evaluations in documentation packages.
  • Participation in supplier assessment and auditing.

Furthermore, you will drive optimizations and projects to improve our working processes. This is a truly important part of the job, as it is essential for our business continuity that focus is on simplicity and adaptability, as new information continuously drives us to change priorities or direction.

We offer an exciting and developing position as part of a dynamic and multidisciplinary team focusing on simplicity and adaptability in their daily work. As the teams grow, new tasks and opportunities are continuously added to the team.

Qualifications

You hold a relevant Master or PhD degree within a field of scientific expertise such as but not limited to Engineering, Biology, Biochemistry, or similar. In addition, we are looking for candidates with the following qualifications:

  • GMP experience in the pharmaceutical industry preferably from a similar role.
  • Coordinating tasks within a large project with many different stakeholders.
  • Excellent communication skills and proficiency in both spoken and written English.
  • Great collaboration skills with a good sense of priority and not afraid to set direction.
  • A team player who enjoys cross-functional, cross-departmental, and stakeholder collaboration.

We are looking for profiles with various levels of seniority and experience. We are open to experienced senior profiles as well as newly graduated profiles with relevant pharmaceutical or manufacturing experience.

The Department

As part of Novo Nordisk PSQIT organization, Chemistry, Manufacturing and Control (CMC) Development & Scaling 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” mind-set.

The department CMC API Process Operations is a part of CMC API development and consists of 100+ colleagues organized in 8 teams. CMC API Process Operations plays a key role in securing patient safety in the clinical trials from the entire Novo Nordisk development portfolio.

The two GMP materials teams consist of around 12 colleagues in each team. We are located in Søborg, and we enjoy social interaction through coffee breaks, walking/running, and dining together. The position is office-based, but we do offer flexibility by working from home up to 2 times a week if the task at hand allows it.

Working at Novo Nordisk

Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 68,000 employees. Together, we go further. Together, we’re life-changing.

Contact

Deadline

6 February 2025

Please submit your application as fast as possible as we will review applications and invite for interviews on a continuous basis. Several positions are available.

You do not need to write a cover letter but please include 10-15 lines about your motivation in the CV, highlighting your key skills and contributions to the position.

Please avoid the use of photos in your CV. This makes for a better and more fair process.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk 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. Together, we’re life-changing.

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