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Manufacturing Associate - Operator

We are looking for process operators, preferably with experience from a similar pharmaceutical production company or similar regulated businesses OR a Life Sciences Graduate who have recently finalized their Bachelor or Master degree relevant for Biologics Manufacturing and are keen on starting their career in a manufacturing and international environment where things move fast.

We are hiring for attitude, so we are looking for people who have a lot of drive and proven interest with working under GMP and enjoy working with numbers, math and IT tools.

Clinical Trial Assistant

Are you looking for the possibility to unfold your competences within clinical operations even further? Do you thrive in an innovative environment working alongside dedicated clinical research professionals? Are you a self-driven team player, who enjoys a varied and influential day at work?

Pharmacosmos A/S is a progressive and innovative pharmaceutical company with headquarters in Holbæk, Denmark. We are on an exciting journey of global growth inventing new and innovative treatments, and right now we are expanding our team with a Clinical Trial Assistant.

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.

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.

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.

Senior Medical Writer

Do you want to work in a global context and according to the highest standards of current practice to provide new products to patients with unmet medical needs?

As a Senior Medical Writer, you will be responsible for delivering submission-ready documents and take the role as lead medical writer on specific assignments. In addition, you can look forward to joining a diverse organisation shaped by cross-functional and global collaboration – and a focus on continuous transformation to support the future needs of clinical development.

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.

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

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 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.

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.

Facility & Utility Engineer med fokus på løbende forbedringer

Brænder du for at sikre den daglige drift og vedligeholdelse inden for facility & utility? Trives du med at koordinere og dagligt være i kontakt med eksterne håndværkere? Kan du lide at planlægge, koordinere og strukturere vedligehold af tekniske installationer og bygninger?

Til denne spændende stilling vil du indgå i en PMO og Utility/Facility afdeling, hvor opgaverne er mange og alsidige. Du vil få den daglige sparring med ingeniører og teknikere i produktionsenheden i Horsens. Du vil varetage en lang række opgaver inden for optimeringsprojekter, og sikre at Facility og Utillity installationerne til stadighed opfylder kravene.

Senior Life Science Business Consultant

Are you an experienced Senior Life Science Business Consultant with a passion for combining life sciences with the business aspects of consulting?

Don't miss this opportunity to advance your career and collaborate with our skilled colleagues to transform the digital landscape for clients all over the world.

You will plan and execute projects for our clients – working collaboratively with others. You will be deeply involved in all project phases from the idea phase, to identifying the value adding areas, analyzing current and future processes and technology needs, vendor selection and implementation.

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.

MS&T Program Manager

We are looking for an experienced professional from the pharmaceutical industry, who can effectively manage project plans across multiple entities and lead cross-functional processes within our own sites and supply chain.

As a MS&T Program Manager, you will be responsible for managing the projects, maintaining project databases, as well as ensuring effective communication and timely achievement of milestones.

Manufacturing Science & Technology (MS&T) Technical Transfer Project Manager (Sr Specialist)

Join Orifarm and take charge of building strong business relationships with a key portfolio of our suppliers!

As a MS&T Technical Transfer Project Manager, you will be responsible for securing technical support to Supplier Relationship Management functions, and manufacturing sites comprising support, technological transfers between CMOs and own manufacturing sites, analytical method development and validation, external product development at CDMOs and driving continuous technological improvement and innovation.

Protein Chemist for production of antibodies for cancer diagnostics

Do you find antibody production exciting?

You will play a key role in daily support of the production of conjugates. This can include:

• Support lab techs in case of technical issues with purification, conjugation, and test of antibodies.
• Handle compliance issues according to GMP standards.

We offer a high degree of freedom and development opportunities in an international company.