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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.

Laboratory Technician

Til vores QC laboratorium søger vi en engageret og dygtig kollega til et 1-årigt vikariat i et af vores teams.

Dine daglige arbejdsopgaver vil bl.a. bestå af

• Udførelse af kvalitetsanalyser f.eks. viskositetsmåling, autotitrering, pH-måling, filtrering og tørstofbestemmelse
• Udførelse af applikationsanalyser i driftslaboratoriet
• Kalibrering af relevant udstyr i henhold til kvalitetssikringsinstruktioner

Arbejdsmiljøet er friskt, behageligt og til tider travlt, men med spændende udfordringer og indflydelse på egen hverdag. Vi har en uformel omgangstone og rummelige kolleger, hvor humor er en vigtig del af hverdagen.

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.

Graduate – Software Automation Program

Cognizant Denmark is currently seeking applications from Graduate Engineers for our Graduate Program in 2024 based in Hillerød, Denmark.

Successful candidates will be part of the Global Graduate Program.

This Program is an intensive 8-week Training Program that consists of Classroom Training, Workshops, Theory, Practical Training, and a Simulation Project.

Specialist, Regulatory Affairs (Temporary Position)

As Regulatory Affairs Specialist, you will be responsible for lifecycle management of products manufactured at Orifarm’s own manufacturing sites. Therefore, you will collaborate closely with colleagues across functions, such as chemists, formulation specialists and co-workers within Quality, Supply Chain, Manufacturing and Sales.

Further, your main responsibilities include to:

• Gather information and documentation for variation applications
• Update dossier sections

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.

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.

Procesingeniør

Har du lyst til at starte din karriere med at arbejde inden for farmaceutisk produktion? Og har du mod på at bevæge dig ud i tværfaglige udfordringer, der ligger lidt uden for din uddannelse?

Vi er en virksomhed i vækst, og produktionsvolumenerne vokser – så derfor har vi et stort behov for at styrke vores ingeniørgruppe med et nyt medlem, der kan medvirke til, at vi får moderniseret vores udstyr, som produktionen vil få stor gavn af.

QC-laborant med varierende opgaver

Har du lyst til at sikre kvaliteten af vores API’er i en QC-funktion, hvor du får lov at løse en palet af forskellige opgaver? Har du lyst til at blive en del af en velfungerende gruppe, hvor du løbende bliver trænet i nye opgaver af dine erfarne kolleger?

Så er det måske dig, der er vores kommende QC-laborant. Vi er i en proces, hvor vi vokser, og derfor søger vi en laborant, der trives med fleksibilitet og gerne vil udvikle sig.

Vi vil altid være lydhøre over for den enkelte laborant. Hvis du har interesse for en opgave, så lytter vi og sørger for, at du bliver trænet i den og får lov til at løse den

Laborant/Senior Laborant

I jobbet som Laborant/Senior Laborant i Translational Pharmacology vil du være ansvarlig for planlægning, koordinering og gennemførelse af in vivo / ex vivo farmakologiske eksperimenter som bidrag til vores prækliniske forskningsprojekter.

Ansvarsområderne omfatter bl.a.:

• Gennemførelse af in vivo-undersøgelser af høj kvalitet i gnavere, herunder bidrag til protokoller, planlægning, udførelse og dokumentation.
• Udførelse af grundlæggende kirurgi hos gnavere, herunder anæstesi og analgesi.
• Prøvetagning og håndtering af blod- og vævsprøver af høj kvalitet.

Analytical Chemist – 12 months position

We seek a highly motivated ANALYTICAL CHEMISTRY scientist, engineer, or technician for our research laboratory in Copenhagen.

The position will give intellectual challenge and rich possibilities to develop your skill sets as well as being part of commercially and scientifically exciting projects.

You will contribute to the development and maintenance of River Stone’s analysis platform, method development as well as routine sample analysis. You will be part of an enthusiastic and strong analytical chemistry team.

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

Downstream processing engineer – 12 months position

In this position you will be part of River Stone’s downstream processing (DSP) team, which is responsible for developing purification methods for our biological production processes for pharmaceutical ingredients.

The ideal candidate possesses:

• M.Sc. or Ph.D. degree in chemical engineering, food process engineering, chemistry, or similar
• Experience within down-stream purification processes, like solid-liquid separation, membrane filtration, crystallization and/or drying is a requirement
• Flair and motivation for hands-on laboratory work
• Ability to work in a fast-paced environment with deadlines and sometimes limited time for data analysis

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.

External Lecturer – “Medical Biotechnology and Drug Development” – DIS Copenhagen

The teaching position is for the fall semester, which will begin in August. You will teach highly motivated undergraduate students from North American universities who are spending a semester studying in Copenhagen.

Why teach at DIS?

• Work in an international, informal and enthusiastic environment with an emphasis on cross-cultural understanding, teamwork, innovation, and adaptability
• Develop interactive and experiential teaching skills and teaching experience in English

Principal DMPK Scientist

Currently, we are looking for a new principal DMPK scientist, who has experience in supporting discovery and development projects in characterization and selection of drug candidates.

Responsibilities

• Design, conduct, and manage in vitro, and in vivo experiments to evaluate the ADME and PK profiles as well as toxicokinetics of drug candidates both in-house and at contract research organizations
• Develop and execute assays for measuring drug concentration and metabolite identification from in vitro and in vivo experiments

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 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 Technical Writer - Regulatory (CMC)

You will join the Technical Writing team within Global Regulatory Affairs. We are responsible for global regulatory CMC writing of regulatory documents in applications for new approvals, worldwide market expansions, and product lifecycle activities. We work with a variety of pharmaceutical products, including small molecules, peptides, biologicals, recombinant products, and gene therapy.

Stepping into an informal and collaborative environment, you will have close interfaces with many different disciplines, including Global Pharmaceutical R&D, manufacturing sites, Product Supply, Quality Assurance, Ferring affiliates, and development sites around the world.