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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.

Clinical Supply Manager

The Clinical Supply Manager will be managing outsourcing of packaging, labelling, and distribution of clinical trial supplies for all clinical trials.

You must have extensive knowledge of cGMP and have a focus on the level of quality in work performed.

We strongly endorse a flexible working environment around its core working hours of 09:00-15:00 and endorses fair and equal pay practices.

Senior Data Manager

The Senior Clinical Data Manager is responsible for leading and overseeing data management activities associated with clinical trials, ensuring data accuracy and consistency, and managing data cleaning and quality control processes.

We strongly endorse a flexible working environment around its core working hours of 09:00-15:00 and endorses fair and equal pay practices.

Biocompatibility Specialist

We are looking for a Biocompatibility Specialist to join the Reprocessing and Biocompatibility team for a 12-month project position.

This is a great opportunity if you would like to gain experience with biocompatibility for advanced reusable medical devices, as you will be part of a cross-functional effort on documenting the safety and performance through the lifetime of our ultrasound scanners, transducers, and accessories.

Ingeniør til validering

Vi har brug for en konsulent til et spændende job indenfor kvalificering og validering. Stillingen byder på mange forskellige opgaver og projekter hos vores kunder på det meste af Sjælland, og du får en spændende, travl og varierende hverdag.

Du vil bl.a. koordinere, planlægge og udføre validerings- og kvalificeringsprojekter, som kan omhandle: rengøringsvalidering, sterilisationsprocesser, procesanlæg, IT-validering, klimafaciliteter, produktions-, måle- og laboratorieudstyr.

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.

Dedikeret farmakoepidemiolog til Lægemiddelstyrelsens Dataanalysecenter

Lægemiddelstyrelsen er en helt unik arbejdsplads, i at vi er Danmarks eneste regulatoriske myndighed for lægemidler og medicinsk udstyr. Med denne position følger et helt særligt ansvar, som vi er meget stolte af og bevidste om i vores arbejde.

Dine primære arbejdsopgaver i Lægemiddelstyrelsens Dataanalysecenter er bl.a.:

• Designe, planlægge og udføre farmakoepidemiologiske analyser på sundhedsdata bl.a. vedr. forbrug, effekt og sikkerhed
• Udarbejdelse af rapporter, notater og præsentationer til forskellige målgrupper

Administrativ laborant

I prøvemodtagelsen registreres alle laboratoriets prøver, kemiske såvel som mikrobiologiske. Der er i prøvemodtagelsen ikke noget analytisk arbejde.

Vi søger en kollega med et stærkt udviklet servicegen, som vil bidrage til teamet. Dine arbejdsopgaver vil bestå af modtagelse, registrering, auditering og distribution af indkomne prøver samt afvigelsesbehandling.

Du vil blive en del af et engageret team på 5, hvor tingene ofte går stærkt, men hvor der også er tid til humor.

Senior Product Test Engineer - Medical Devices

Do you want to design safe and reliable medical devices, bringing our clients' life-changing solutions into the hands of patients and helping patients to get better treatment?

You will be an essential contributor in the development and designing optimal verification methods for requirement confirmation.

We seek to enable the best work environment that helps you and the business work together to produce superior results.

Ruminant Nutritionist – Calf and Lamb Milk Formulations

This is an great opportunity to join our international team that continues to invest in the Ruminant offering looking at way to innovate and enhance our formulations, and additives that support the needs of young animals with some other responsibilities such as:

• Supporting R&D activities, including feed material and product evaluations, trials, and commercial interpretation and communication.
• Develop technical ideas to add value to product sales and marketing.

Health, Safety and Environment (HSE) Manager

Are you a seasoned Health & Safety professional seeking an opportunity to thrive in a supportive and dynamic environment?

We have an exciting opportunity to recruit a Health & Safety Manager, you will play a crucial role in maintaining and enhancing the safety standards at our facility. Your responsibilities will include designing training programs, conducting risk assessments, identifying, and controlling hazards.

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

Head of the Department of Virus & Microbiological Special Diagnostics

Do you have solid management experience and deep insight and experience within virology?

As Head of the Department of Virus & Microbiological Special Diagnostics, you are responsible for the daily management of the department to ensure the diagnostic preparedness for infection in a one-health perspective with synergy between laboratory diagnostics in humans and animals.

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.

Department Manager for Molecular Pharmacology

Gubra is seeking a dedicated and experienced Department Manager to lead our Molecular Pharmacology department. The ideal candidate will possess proven leadership abilities and a passion for managing and developing teams, along with a background in molecular pharmacology and drug discovery.

Your tasks include

• Daily management of a team of scientists and lab technicians to ensure high performance, personal development, well-being and engagement.
• Guide the team to accomplish department goals and objectives.
• Oversee the planning, execution, and analysis of experiments to support Gubra’s internal and partnered drug discovery projects.

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.

Laborant eller procesoperatør til bufferproduktion til cancerdiagnostik

Vil du bidrage til diagnostik af cancer og gøre en forskel for patienter? Bliver du motiveret af laboratoriearbejde i et travlt produktionsmiljø? Er du detaljeorienteret og lægger vægt på korrekt produktion og dokumentation?

Vores hverdag består hovedsagelig af produktioner, grundig dokumentation og reviews men vi prioriterer også tid til løbende forbedringer af vores arbejdsgange og processer.

Der er tale om en fuldtidsstilling på 37 timer per uge. Arbejdstiden ligger i dagtimerne og vi har flextid.

Product Manager til Life Science-produkter

Har du erfaring fra medicinal-/biotekindustrien eller på anden vis kendskab til laboratoriearbejde? Kunne du tænke dig at arbejde med kundepleje og salg af specialiseret udstyr til celledyrkning og fermentering?

Centrum Personale søger en Product Manager til en veletableret virksomhed, som leverer specialiserede kvalitetsprodukter til Life Science- og pharma-kunder.

Ved opstart bliver du omhyggeligt sat ind i produkterne og besøger leverandørerne. Derefter planlægger og tilrettelægger du selv din arbejdsdag, men indgår i et team med de øvrige Product Managers. Du besøger kunderne i faste intervaller, samarbejder med serviceteknikerne og følger løbende op på igangværende sager og projekter.

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.