Pharmaceutical Raw Materials Expert
2 weeks ago
Job Description
We are seeking a highly skilled Raw Material Qualification Specialist to join our team in CMC API Process Operations at Novo Nordisk A/S. As a key member of our team, you will be responsible for ensuring the suitability of materials for GMP production to clinical trials from the entire Novo Nordisk development portfolio. Your expertise will be crucial in maintaining the high quality and compliance of our GMP materials.
About the Role
In this role, you will work closely with various stakeholders, including project management, process development, the Cell Therapy Unit, CMC API Pilot facilities, and facilities in the US. Your responsibilities will include:
- Qualifying different types of materials (raw materials, consumables, excipients) for GMP production, including setting internal release specifications for the warehouse and quality control.
- Closely collaborating with external stakeholders, such as material suppliers and logistics services, to ensure patient safety, GMP, and GDP compliance.
- Collaborating with internal stakeholders to ensure proper scientific evaluations in documentation packages.
- Participating in supplier assessment and auditing.
Requirements
To be successful in this role, you will need:
- A relevant Master or PhD degree in a field of scientific expertise, such as Engineering, Biology, Biochemistry, or similar.
- Experience in GMP in the pharmaceutical industry, preferably from a similar role.
- Excellent communication and collaboration skills, with strong proficiency in both spoken and written English.
- A good sense of priority and not afraid to set direction.
- Team-player skills with a passion for cross-functional, cross-departmental, and stakeholder collaboration.
About Us
Novo Nordisk A/S is a world-leading healthcare company that is dedicated to making a meaningful difference to people's lives. Our company is built on a vision of a world that empowers people to live healthier lives.
Please note
This is a unique opportunity to join a dynamic and multidisciplinary team that is passionate about making a difference. If you are a motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply for this role.
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob Title: Development Scientist for Raw Material QualificationJob Summary:We are seeking a highly skilled Development Scientist for Raw Material Qualification to join our team in CMC API Process Operations. As a key member of our team, you will be responsible for ensuring the suitability of materials for GMP production to clinical trials from the entire...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled Development Scientist for Raw Material Qualification to join our team in CMC API Process Operations. As a key member of our team, you will be responsible for ensuring the suitability of materials for GMP production to clinical trials from the entire Novo Nordisk development portfolio.Key ResponsibilitiesGMP...
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