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Technician, EMA Solids Support Team

Welcome to Solid Support Team 13 skilled process engineers and technicians responsible for quality, introducing new products, throughput, and optimizing the products.

In this role you’ll make an impact by:

• Responsible technician for the MG-coating line, ensuring smooth and efficient coating processes for granulating with MnTACN
• Coordinate the steering system changes, bridging the gap between process engineers, technicians, and programmers to optimize operational efficiency.

Regulatory Affairs Specialist

The RA Specialist for Radiometer is responsible for ensuring coordination of regulatory activities for a few of our Blood Gas products manufactured in California to help ensure continued compliance in all markets.

In this role, you will have the opportunity to:

• Facilitate coordination of regulatory activities between California and Denmark for design control activities and international registrations for a few of the instruments/consumables manufactured in our California site.
• Ensure compliance with EU regulations.
• Generate STED files, international submissions & assess design changes.
• Plan and execute projects for new regulatory requirements.

Senior Regulatory Specialist

The Senior Regulatory Affairs Specialist at Radiometer is responsible for collecting and generating documentation for product submissions to ensure compliance with international regulations. This role is critical for ensuring that Radiometer's products can be sold in markets around the world.

If you thrive in a fast-paced environment, are used to playing a critical supporting role and want to work in a world-class efficient team that is part of a Global RA department and have interactions and stakeholders to connect with in a global scale - read on.

Regulatory Affairs Manager

The Regulatory Affairs Manager at Radiometer is responsible for managing the preparation and submission of the required documentation for product registration, approval, and compliance with international regulations.

This role is critical for ensuring that Radiometer's products can be sold in markets around the world. You will have the opportunity to:

• Ensure regulatory compliance to maintain market approvals
• Lead a team of skilled RA associates
• Ensure alignment with relevant stakeholders

Senior Specialist Clinical Safety and Pharmacovigilance (CSPV)

At Bavarian Nordic, we aspire to save and improve lives by developing innovative vaccines that are designed to unlock the power of the immune system.

The global team consists of subject matter experts for vaccine safety who work either from our site or remotely in Denmark and globally. Together they constantly collect and assess data for the life cycle benefit risk management across our vaccines whether authorized or still in clinical development.

You would add your clinical safety and pharmacovigilance expertise as your depth knowledge of the PV legislation to the team.

Senior LIMS Specialist for Global QC Development

In this role you’ll make an impact by working as a Senior LIMS Specialist in our team, where you will take part in management of projects for LIMS changes across QC laboratories and other stakeholders including implementation, documentation and communication.

Future projects could be introducing and validating LIMS solutions on new equipment or technologies, new LIMS functionalities, improving and aligning existing processes.

Senior Engineer Device Manufacturing

Are you passionate about cutting-edge medical technology? Do you thrive in a collaborative environment where innovation drives patient care?

Amgen, a global biotechnology leader, is expanding its device development capabilities in Denmark and is seeking a talented Senior Engineer to join our Device Engineering group.

Manufacturing Science & Technology (MS&T) Technical Transfer Project Manager (Sr Specialist)

Join Orifarm and take charge of building strong business relationships with a key portfolio of our suppliers!

As a MS&T Technical Transfer Project Manager, you will be responsible for securing technical support to Supplier Relationship Management functions, and manufacturing sites comprising support, technological transfers between CMOs and own manufacturing sites, analytical method development and validation, external product development at CDMOs and driving continuous technological improvement and innovation.

Protein Chemist for production of antibodies for cancer diagnostics

Do you find antibody production exciting?

You will play a key role in daily support of the production of conjugates. This can include:

• Support lab techs in case of technical issues with purification, conjugation, and test of antibodies.
• Handle compliance issues according to GMP standards.

We offer a high degree of freedom and development opportunities in an international company.

Analyst and Project Coordination In Life Science Consultancy

Would you like to work with data analysis and research of worldwide trends in the pharmaceutical and biotechnological industries?

You will get the responsibility of managing and coordinating the day-to-day operations needed to solve our projects and writing reports for our commercial unit.

An academic background in life science (pharmacy, biotechnology etc.), economics or similar is required.

Manager Virus Production

Do you want to play a central and important role in Bavarian Nordic´s manufacturing strategy by setting directions and ensuring smooth daily operation in our production facility?

Our newly established Drug Substance Facility in Kvistgaard will soon start production ramp-up, and we therefore need to strengthen our leadership. You will become responsible for the day-to-day shopfloor management of 15-20 operators.