Do you have in depth experience within Sterile Filtration of drug product, and a service mindset to support global manufacturing of Injectable Finished Product? Are you ready to make an impact on a global scale in a highly regulated industry? Do you thrive in collaborative environments where teamwork drives innovation?
If so, this could be the position for you. We are looking for a Sterile Filtration Professional, who can join our team of Formulation and Filtration experts, to support Injectable Finished Product (IFP) sites globally. Apply now and join us!
The position
As a Sterile Filtration Professional, you will be responsible for providing detailed knowledge of the filtration process and its interaction with our various products to a wide range of stakeholders. You will also use critical thinking to efficiently provide support in production-impacting cases. In your role as a product and process owner, you will play a key role in the global strategic launch of our products, aiding in submissions and global product launches. To ensure stable product delivery to our patients, you may also address manufacturing queries from partners related to the filtration process. Additionally, you will be in contact with our filter suppliers, conducting audits, and coordinating ongoing external validations.
To be a proficient filtration expert, you will need to first establish a foundation of knowledge of the neighboring processes formulation and filling as well as establish a minimum product knowledge of our Novo Nordisk IFP products.
You will give input to critical production deviations from IFP, local manufacturing and contract manufacturing sites, additionally do some specific tasks such as:
Preparing documentation of product-specific filter validation for regulatory purposes and supporting IFP sites during routine inspections by presenting internal and external filter validations.
Maintaining and updating process specific documents.
Assisting in upscaling or product transfers via validation review of our processes and product as well as reviewing validation and registration documents.
Assisting and directing optimization projects to improve IFP filtration activities.
Training of peers and sites in handling of the filters and conducting integrity testing on them.
Furthermore, we encourage a flexible and collaborative approach, as we often encounter changing priorities and work within short deadlines to best serve our production sites. Our team is dynamic and aims to support each other, effectively sharing the workload and ensuring the best possible support for our stakeholders.
Qualifications
To succeed in this role, you have:
An academic degree within science, engineering, pharmacy or similar.
Some years of experience working within a GMP environment, preferably in drug product manufacturing.
Excellent communication skills, with experience of working effectively with stakeholders.
Formulation knowledge and experience with sterile filtration and / or validation as well as project management or LEAN qualifications are considered an advantage.
Fluency in spoken and written English.
On a personal level, you have strong communication skills that are vital for cross-functional collaboration with stakeholders at all levels. With a LEAN mindset, you ensure efficiency amidst urgency, adeptly managing multiple tasks with organizational finesse. As our organization is rapidly expanding, we value bold engagement and a focus on working smarter, not harder.
About the department
Our department, Site Support and Improvements, is part of Manufacturing Development, which is a part of the Injectables Finished Products organization. It is based in Søborg, Denmark. In Manufacturing Development, we have the expert knowledge of our products and the processes which is needed to support our production sites.
In our team, we take ownership for the product quality of each drug product manufactured in IFP, based on our deep product knowledge and a network of experience of the formulation processes globally. We are the link between API & Filling, here efficient and effective filtration is critical for our product quality and patient safety.
You will be working in a team of 12-16 subject matter experts and Regulatory writers. Whilst working independently in this position, you will have support of highly skilled colleagues within formulation and filtration, as well as support from across the entire department in related processes which impact product quality.
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