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Nyuddannet proces, - eller industrioperatør til fermentering i medicinalproduktion hos Xellia

Er du teamplayer af natur og parat til nye udfordringer?

Som operatør vil dine primære arbejds- og ansvarsområder være:

• fyldning, sterilisering, podning, fermentering og høst
• overvågning og betjening af procesanlæg
• overvågning og betjening af forsyningsanlæg, herunder vandanlæg og nedbrydningsanlæg

QA Assistant, GS-5, QAC

This position is embedded in the Quality Assurance Centre (QAC), where teams have coreresponsibilities around quality assurance and quality control of supply processes and the productswe procure and deliver.

The incumbent will beresponsible for assisting the Quality Assurance Specialist (non-pharma) in the management of all aspects of Pre-Delivery Inspection (PDI) arrangements for non-pharma items from initial request tofinal invoice certification.

PhD Formulation Innovation Scientist

Do you want to help us revolutionize an industry & build your experience with technologies intended to improve the bioavailability of BSC class II & IV drugs?

As our new formulation Scientist, you will specialize in the delivery of cannabinoids; you will play a vital role in our organization, being part of our early-phase development. You have a scientific and innovative mind-set and understand how to translate knowledge into new technological achievement in relation to delivery.

Clinical Supply IRT/RTSM Specialist

Come help us deliver high-quality clinical trial supply to trials all over the world

We are looking for an IRT/RTSM specialist to help us ensure timely setup of IRT/RTSM systems to support the delivery of trial supply for Ferring clinical programs globally.

In this role you are expected to not only collaborate closely with cross-functional teams but also contribute to a knowledge-sharing mindset and promote a collaborative and innovative work environment. You must have a flair for respectful communication with a range of stakeholders such as Clinical Operations, IT and Quality Assurance.

QA Specialist for Environmental Support

In this role, you will join Bavarian Nordic's QA Organization as a QA Specialist tasked with establishing strong relationships with stakeholders, effectively communicating GxP requirements, and handling crucial Quality Events in the Quality Management System (QMS).

This is in the context of environmental monitoring, aseptic performance, and sterile & low bioburden processes in Drug Substance and Drug Product Production. Additionally, you will contribute to the ongoing improvement of QA processes to elevate overall quality standards.

Senior Process Specialist

Do you want to be part of Process Support in a company with a unique impact on global healthcare? Grab this opportunity to be part of a fast-growing company ready to invest in you.

You will become a process owner of one or more of our production processes in SFI. This means that you will be responsible for, among other things, validation documentation, revalidations, and risk assessments for the specific process.

Manufacturing Support Documentation Associate

Do you have a flair for compliance and can handle many stakeholders? Are you looking for a position where you can take on responsibility?

About the position:

• Create and maintain records and procedures by collecting information from stakeholders to supply manufacturing with compliant documents.
• Start-up events and support investigations by giving input as procedural SME.
• Support the change process by writing SME assessment to ensure procedural alignment. Perform timely closure of action items to ensure reliable execution of production.
• Continuously improve the department processes and support stakeholder improvement projects.

(Senior) Drug Substance Specialist

We are currently seeking a (Senior) Drug Substance Specialist who is energized by collaborative and fun teamwork, excels in handling complex tasks, and enjoys continuous learning.

Your responsibilities will include late-stage drug substance development, up-scaling and process validation as well as support in the commercial phase. Effective coordination with external partners is a significant aspect of this role.

Senior QA Specialist

You will be part of our QA Business Support Team, consisting of 12 QA Specialists and Senior QA Specialists, allocated to projects including innovation projects, capacity projects and strategic QA/QC projects. We participate in projects both as quality and compliance experts to ensure compliance with the requirements for Class III Medical Devices.

We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.

QA-specialist, der er QP-delegeret eller drømmer om at blive det

Drømmer du om at bidrage til at sikre kvaliteten af livsvigtige lægemidler, der redder liv? Er du en erfaren kvalitetsspecialist med erfaring fra lægemiddelproduktion?

Som delegeret Qualified Person (QPd) i vores Manufacturing QA (MQA) afdeling får du en unik mulighed for at arbejde med kvalitetssikring og frigivelse af Xellias produkter. Du vil være med til at sikre, at vores antibiotika når frem til patienter i hele verden i den højeste kvalitet. Som delegeret QP hos Xellia får du et stort ansvar.

Regulatory Affairs Clinical Specialist

Due to many activities in our exciting clinical development projects, we are seeking two new colleagues to our Regulatory Affairs function.

Your key responsibilities will be to contribute with regulatory expertise to global strategies and execution within your assigned project(s). You will be the regulatory responsible in the clinical trial teams and provide regulatory guidance and support for the planning, execution, and reporting of clinical trials worldwide.

Business Developer with a background in Science

Do you want to be at the forefront of Targeted Radiopharmaceuticals and Molecular Imaging?

We are looking for a professional Business Developer with a background in life sciences and the ambition to contribute to further strengthening Minerva Imaging as the trusted partner for targeted radiopharmaceuticals and molecular imaging.

What truly matters is your passion for the advancement and know-how of our scientific studies and your ability to foster long-term relationships with our collaborators.

Test & Reliability Engineer - Sustaining Engineering, Medical Devices

Do you have a keen eye for Physical Testing, Product Quality, Reliability, Validation, and Documentation? Are you looking for an opportunity to merge your passion with our expertise in the Test and Verification of Infusion Care Medical Devices, for the treatment of chronic diseases such as Diabetes and Parkinson’s Disease?

As a Test Engineer, you will be involved in developing and working with a diversity of physical test methods. Planning and coordinating tests in our laboratory in Osted near Roskilde, and partners within Global Convatec and external. Most of your time, you will be part of a project team in SEG.

SAP Master Data Specialist

Do you want to be a part of Process Support in a company with a unique impact on global healthcare?

You will be coordinating SAP production master data activities throughout the organization in order to achieve safe and predictable product implementation, maintenance, and decommissioning.

Here you will not only get to impact the production and development of our products; you will also have every opportunity to develop and grow your own skills.

Senior Vice President, Global Chief Medical Office

We are seeking a highly experienced and dynamic medical executive to join our Global Research & Development organisation in a newly established senior leadership role as SVP, Global Chief Medical Office (GCMO).

In this role, you will act as scientific advisor to the EVP of R&D and the Global R&D leadership team, and your primary objective will be to ensure “one global medical voice” for ALK internally and represent the medical voice of ALK externally.

Senior Specialist til QC hos Xellia Pharmaceuticals

Drømmer du om mere ansvar, med forskelligartede opgaver, og har du en passion for mikrobiologi? Vil du spille en central rolle i Xellias produktionen af livsvigtig antibiotika?

Som senior specialist vil du blive faglig ansvarlig for vores count release-laboratorie, som bl.a. udfører TVC- og LAL-analyser. Derudover vil du indgå i tæt samarbejde med vores sterile produktioner angående EM, hvor de nye Annex 1-krav stiller øgede krav til vores compliance, som du vil spille en vigtig rolle i.

Medical Advisor med kommerciel tilgang

Har du lyst til at arbejde sammen med dygtige og passionerede kolleger, hvor du kan gøre en stor forskel med dine faglige kompetencer og være en vigtig drivkraft i at udvikle det faglige samarbejde med vores kunder?

Din primære opgave er at rådgive omkring vores produkter i den primære og sekundære sektor. Herunder at opbygge et tæt netværk af relevante health care professionals.

Training Partner

Are you passionate about designing high impact training to improve ways of working?

The role will focus on re-designing the training related to onboarding our professionals working directly with our operation, our Operators, and our Laboratory Technicians.

You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words.

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.