Primary Packaging Material Specialist

1 week ago


Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

About the Role

As a Primary Packaging Material Specialist, you will be responsible for managing the Life Cycle Management (LCM) of Risk Management documentation packages related to Primary Packaging (PrimPack). This position involves working in a scientific environment with engaged colleagues and collaborating closely with various areas such as R&D, Production, and Supply Chain. Key tasks include reviewing and updating Risk Evaluation and Control Agreements when implementing new or modified Drug Products or combination products. You will also be responsible for reviewing and updating agreements when new or modified manufacturing and production processes are implemented. Additionally, you will oversee proactive process compliance with internal and external requirements and govern the LCM of PrimPack product risk documents including readiness for periodical reviews. Furthermore, you will oversee the transfer of the risk package to PrimPack Injectables.

Key Qualifications
To be successful in this role, you should hold a master's degree or Ph.D. in engineering or another relevant field within the natural sciences. Experience working in a GMP environment, risk management tools, system engineering, safety risk management, and quality specifications is essential. You should have experience within medical device development and a strong understanding of medical device regulations and standards. Proven track record of successfully managing risk within medical device development projects from concept to commercialization is required. The ideal candidate will be fully proficient in written and spoken English, highly conscientious, and structured in their work. Excellent communication and leadership skills, along with the ability to effectively collaborate with cross-functional teams, stakeholders, and external partners, are necessary. A positive attitude, forthcoming demeanor, and motivation by teamwork are essential qualities for success in this role.

About the Department
You will join the Material Manufacturing Development - Primary Packaging Department in Product Supply, Sourcing Operations at Novo Nordisk headquarters in Bagsværd, Copenhagen. This department is characterized by innovation, openness, and highly engaged colleagues who work dedicated to changing lives for the better for patients worldwide. The team consists of approximately 50 employees organized into four teams and is continuously growing. Responsibilities include implementing complex Primary Packaging materials and maintaining documentation on existing materials. Collaboration occurs with various functions, including CMC, Device R&D, QC laboratories, QA, several Novo Nordisk production sites globally, and numerous external suppliers and contract manufactures (CMO).

Career Opportunities
We offer competitive compensation with an estimated salary range of $80,000 to $110,000 per year based on qualifications and experience. In addition, we provide excellent benefits, opportunities for professional growth and development, and a dynamic work environment.

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