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The division’s research is inter-disciplinary and involves assessment of chemical substances in food and in the environment, as well as risk assessment of GMOs and zoonoses.
The division hosts monitoring data on nutrition, food chemistry and microbiology, including data generated by the Danish Veterinary and Food Administration. It is our ambition to increase the use of monitoring data for research purposes.
You will be part of Group for Chemical Risk Assessment and GMO in the Division of Risk Assessment and Nutrition, where our main focus is on research based policy advice to Danish authorities. The focus of the advertised position is risk assessment of genetically modified viruses, animals and plants and also on chemical risk assessment in relation to food.
Aureum A/S, Lynge, Nordsjælland
On 1 January 2018, the act on the medicinal cannabis pilot programme entered into force. Hence, a special development scheme for the cultivation and manufacturing of medicinal cannabis was introduced. The Danish Medicines Agency regularly issues cannabis cultivation- and production licenses with the purpose of supplying cannabis intermediate products to the pilot programme.
As Quality Professional you will be responsible for ensuring manufacturing of oils are in compliance with European GMP. Your job will cover a wide range of responsibilities, among other tasks:
- Assisting in designing the company’s Quality Management System.
- Authoring, reviewing and approval of SOP’s, Forms and Templates.
- Support in qualification and validation activities in relation to implementation and maintenance of manufacturing equipment and facility – including utilities and QC equipment.
Chr. Hansen A/S, Hørsholm
In our Stability & Technology department you will reinforce the existing team of 7 competent and engaged colleagues working in a creative environment. The department cooperates with customers, colleagues, universities and research institutes both nationally and internationally.
This is an outstanding and unique scientific position where your responsibilities will count:
- Set the standards for formulation technology of bacterial cultures at Chr. Hansen
- Formulating and stabilizing bacterial cultures for multiple applications
- Conducting downstream processing studies, validation activities, and characterization activities of biologic products
We work in cross-functional projects, therefore responsibility, engagement and team playing are core values for you – as it is for us
We are looking for a Principal Scientist with a strong research background in psychiatric disorders and molecular biology training to join the Lundbeck Research Neuroscience organization in the department for Signal Transduction. As part of the larger Lundbeck R&D organization, we are focused on utilizing molecular and cellular neuroscience to establish the pharmacodynamic mechanisms of drug candidates at the cellular level and to continuously develop our understanding of disease biology and therapeutic entry points.
Your job and key responsibilities
- With your in-depth understanding of psychiatric disorders and with your firm grasp of genetics, molecular and cellular biology you will contribute with scientific leadership and key experimental data to guide and ensure the progression of drug discovery projects.
Do you have profound experience with regulatory CMC for biopharmaceuticals? Would you like to share your experience and be part of building up expertise within biopharmaceuticals across Lundbeck? Then you might be the new colleague we are looking for.
Lundbeck has traditionally worked with small molecules, but we are now also aiming to develop the competences necessary to be a key player in development of biopharmaceuticals (such as monoclonal antibodies). You will have a key role in this new strategy.
In your new job, you will be:
- Responsible for all Regulatory CMC activities on biopharmaceuticals development Projects
- Responsible for developing the Regulatory CMC strategy for assigned Projects
The Regulatory Submission Management & Telematics Department is responsible for the critical operational activities relating to compilation and submission of marketing authorisation applications, regulatory data management and implementation of labelling and manufacturing changes in the production area.
Lundbeck Regulatory Information System (RIMS – ArisGlobal Register) is used for tracking information regarding Lundbeck's registered drug products globally. The system is used throughout the organisation in relation to e.g. life cycle management and release of products.
As Regulatory Data Manager, your main responsibility areas will be:
- Data entry
- Data quality activities
- Daily support and problem resolution for end users
Coloplast A/S, Humlebæk
You will be commercially responsible for our Wound and Skin Care category and work on development projects from realisation through to launch. We are working on early stage projects, which include extensive market research – as well as more mature projects where we focus on product usability studies and product launch readiness.
Your main areas of responsibility will be delivering commercial input to product development projects, collecting user insight, assessing market size and attractiveness and developing new product launch strategies. Specifically, you will:
- Act as marketing lead in a cross-functional development team and provide commercial and marketing directions to the product development phases to secure a successful outcome
- Work with commercial and clinical stakeholders in collecting product category user insights to support the formulation of superior product positioning
Albright Life Sciences A/S recruiting on the behalf of AJ Vaccines in Copenhagen
Would you like to challenge yourself and daily see the value and impact of your deliverables through building key customer relations and sales through distributors delivering high quality vaccines that fulfil a global public health mission? Then come join the Sales & Marketing Team as Regional Sales Manager.
Your main responsibility will be to build customer relations and sales through distributors operating in a tender-based and special permit market while supporting, training, motivating and developing them and their sales teams to meet strategic growth- and revenue goals.
Our Sales and Marketing Department currently employs 10 people. Our activities cover all aspects of Sales, Marketing and also includes Shipping. Travelling: 50-60 days yearly is expected.
Y-mAbs Therapeutics A/S, Hørsholm
A new position is now open! Y-mAbs Therapeutics A/S (Y-mAbs) is looking for a CMC Project Manager. You will primarily focus on CMC activities associated with our late stage biologic development programs, and you will work with close interfaces to other functional groups within Y-mAbs. A good understanding of the outsourcing process, from quotations and contract negotiations to follow-up and troubleshooting with our CMC partners is a key competence as all manufacturing is outsourced.
It is key that you have in depth expertise within one of the following areas:
- Specific knowledge about drug product development in late stage development programs including commercial launch
- Formulation development of biologics – knowledge about sub-cutaneous formulations will be an advantage
- Solid experience in working with CMO/CRO's and international regulatory bodies like FDA and EMA
LEO Pharma, Ballerup
Are you passionate about creating a compliant environment while optimising business performance?? Do you want to ensure compliance in our collaborations with healthcare professionals (HCPs) and healthcare organisations (HCOs)?
As Senior Healthcare Compliance Specialist you are a highly valued partner to the business supporting the global LEO Pharma organisation in HCP/HCO engagements. Your knowledge of and advice on the internal policies and applicable laws, regulations and ethical standards for engaging HCPs/HCOs is a cornerstone in securing that the business is compliant in collaborating with HCPs and HCOs.
Unique Human Capital recruiting on behalf of Orphazyme A/S in Copenhagen
Make a difference in a progressive and innovative biopharmaceutical company
Orphazyme is a very ambitious and visionary company. The company has had a good and well-paced growth during several years meaning that they are very much in control of their business and have well driven processes.
As Head of Clinical Operations at Orphazyme you will have the overall responsibility for the delivery of the clinical trial pipeline. You will be accountable for managing the clinical operations resources ensuring efficient and effective allocation enabling delivery of the trials.
The Head of Clinical Operations position is based in the Department of Clinical Development. The department is responsible for formulating, overseeing and directing clinical development activities, typically with the assistance of CROs.
Thermo Fisher Scientific, Roskilde
Do you enjoy creating results in a fast-paced environment, and do you want to be an important part of a strong commercial team working together to help our customers make the world a better place?
In this role you will maintain effective customer relations, develop opportunities for growth within an existing customer base, and assure market penetration and profitability while achieving sales and profit forecasts. You may be based in the greater Copenhagen area (Denmark) – or Southern Sweden.
Your further responsibilities among others will include:
- Meet or exceed business goals of our commercial targets for the territory
- Drive the tactical implementation of the business plan – including sales to new accounts, successful introduction of new products, and the retention of current customers
Radiometer Medical ApS, Brønshøj
Har du minimum 3 års erfaring fra pharma eller life science indenfor labeling? Forstår du vigtigheden af compliance og den krævende regulatoriske verden? Kan du levere den præcise labeltekst, der er brug for?
Så kan du være vores nye labelspecialist, der supporterer Radiometers mange afdelinger i Danmark og udlandet og på den måde bidrager til Radiometers mission om at hjælpe sundhedspersonale til at træffe diagnostiske beslutninger, der redder liv.
Forvent en travl hverdag med mange henvendelser, hvor du fungerer som sparringpartner i forhold til den grafiske udarbejdelse af de påkrævede labels. Nogle af dine kerneområder er, at
- udarbejde og opdatere labels
- udarbejde projektplaner gerne i MS projekt
- oprette ECO (Engineering Change Orders) og sende til godkendelse
The Assessment Company Sverige AB, Stockholm
United Nordic works with the coordination of international sourcing & procurement of private labels products under labels as Eldorado, Garant, Gestus, First Price, Smart Pet, Fixa and Unik etc. and deals with both food and non-food suppliers from around the world.
We are now looking for our next Private Label Quality & CSR manager, located in Stockholm. Main responsibility includes strategic development of the joint quality work between the companies. You will also be responsible for project management and coordination of our Nordic quality work for private labels.
- Lead our Nordic Quality Council, consisting of quality managers from members
- Facilitate knowledge exchange and development between the members
- Lead harmonization of quality work including requirements and guidelines
Coloplast A/S, Espergærde
Do you have a bright and curious mind? And would you like to see your creative ideas turn into new innovative products for future full-scale production?
As process engineer, you participate in 1-2 new product development projects at a time to develop and define all production processes, e.g. identifying manufacturing equipment and methods. Ensuring efficient process scalability from pilot to high-volume production, you:
- Design processes and build prototypes in close collaboration with our designers, R&D and workshops
- Develop, document and verify process stability and scalability for new products ready for production ramp-up
- Follow up on results and create action plans, risk assessments and cost efficiency calculations
Coloplast A/S, Humlebæk
Do you have a strong track record for delivering projects?
We are looking for an experienced project manager who can effectively lead a cross functional team to develop manufacturing processes, plan and commission production machines and to support all aspects of product development. You will be responsible for creating the Manufacturing Plan and for ensuring that the project progresses according to that plan throughout the project lifecycle.
Key areas of responsibilities
- Drive project execution of the manufacturing area in the project. Ensure agreed project KPIs are met. Apply best project management practices to lead and steer the project team members safely through all stages of the project. Ensure the deliveries follow the AIM 2.0 stage gate model.
- Stakeholder management and effective communication with all the cross functional business partners to ensure clarity and satisfaction.
AJ Vaccines A/S, København
Kan du lide at tage ansvar? Trives du i en alsidig hverdag? Nyder du at have flere bolde i luften på samme tid? Er du en teamplayer? Så har vi et job, der vil interessere dig!
Som vores nye kollega bliver du en del af QC Raw Materials, Microbiology og Cleanroom (QC-RMC), der er en afdeling med ca. 60 medarbejdere fordelt på fem Units.
Du vil indgå i Packaging Materials akademikergruppe, og dine arbejdsopgaver vil afhænge af dine kompetencer og det aktuelle behov i QC-RMC. Gruppens opgaver omfatter:
- Udarbejdelse og godkendelse af diverse specifikationer
- Behandling af ændringsanmodninger og ændringskontroller (CR/CC)
- Udarbejdelse af instruktioner, protokoller og rapporter
AJ Vaccines A/S, København
Vi søger produktionsmedarbejdere til aseptisk produktion af vacciner og tuberculinprodukter. Vi har brug for flere produktionsmedarbejdere, der finder GMP-produktion interessant og vil indgå i et team, der har plads til smil. Der er fast arbejdstid i oplæringsperioden fra kl. 10-18. Efter oplæringsperioden vil arbejdstiden være fra kl. 13.00 – 21.30 (hver anden fredag kl. 11.30 – 17.00.)
Vi formulerer og påfylder vacciner og andre produkter i hætteglas og sprøjter. Alt arbejde foregår i klassificerede renrum. Du starter i et praktisk og aseptisk træningsprogram, som består af læsning af instruktioner og sidemandsoplæring. Opgaverne er:
- Aseptisk blanding af formuleringer
- Påfyldning af produkt i sprøjter og hætteglas
- Udførelse af inprocesmålinger
AJ Vaccines A/S, København
Vi søger en driftsingeniør, der brænder for at arbejde med produktionsudstyr i en farmaceutisk produktionsvirksomhed. Vi er i kraftig vækst, så vi har brug for en kollega med et godt drive, der kan tilføre ny viden og kompetencer i denne spændende udvikling.
IPV produktionens faciliteter gennemgår i øjeblikket en større ombygning, der skal sikre, at vi fremadrettet kan opfylde behovet for øget output samt overholde nye krav fra myndigheder.
Som vores nye driftsingeniør vil du bl.a. få ansvar for at:
- Behandle tekniske afvigelser, CAPA’er og ændringssager
- Udarbejde og vedligeholde instruktioner
- Udarbejde kravspecifikationer og risikoanalyser
LEO Pharma, Ballerup
Would you like to play a key role in the development of our growing portfolio together with a Global, friendly, ambitious and professional team of Clinical Trial Supply Professionals?
As a Clinical Trial Supply Sr. Professional you will join a very dedicated team, who is responsible for managing IMP outsourced related activities in connection with the conduct of Clinical Trials Phase I-IV. You will be working according to given LEO Pharma procedures and relevant GMP, GCP, GDP and regulatory requirements. You will also:
- Create SOP´s and keep them updated.
- Participate/lead in cross-functional optimizing Projects
- Present at Investigator/CRA meetings