22 job matcher din søgning
CMC Submission Specialist
Zealand Pharma A/S, Glostrup
Zealand Pharma A/S (Zealand) is looking for an experienced CMC and Device Submission Specialist who in collaboration with CMC scientists will be responsible for the writing and reviewing of CMC submission documentation that lives up to Authorities’ expectations from a content perspective.
The successful candidate will be responsible for the CMC and Device content of initial NDAs, during Q&A and subsequent lifecycle management activities:
- Drive the CMC and Device regulatory documentation gap analysis and plan mitigation strategies together with your regulatory affairs counterparts
- Coordinate CMC and device writing activities with several CMC scientists (API, DP, Device, Analytical and CMO Manufacturing)
- Be key writer to ensure content and storyline of the CMC and Device sections of submissions and authority questions/answers.
Quantitative Modelling of Cell Metabolism (QMCM) is a new section at the Novo Nordisk Foundation Center for Biosustainability (DTU Biosustain).
In QMCM, we focus on developing mathematical models to explore and explain the molecular basis for homeostasis – the self-regulating processes evolved to maintain metabolic equilibrium in organisms.
The successful candidate will be primarily responsible for providing high-throughput quantitative metabolomics analyses to biological researchers. Assays will include targeted metabolomics and flux analysis using both LC-MS and GC-MS. The successful candidate will be involved in communicating with users, participation in experimental design, sample preparation, Instrument analysis, data interpretation, and instrument management.
We are looking for very talented PhD organic chemists with a strong background in synthetic organic chemistry to work at our small-scale development site in Lumsås, Nordvestsjælland, approximately 35-40 min from Roskilde.
The position is in our Safety and Technical Chemistry group in Lumsås and is part of the Process Chemistry group. It is responsible for the supply of multi-Kg amounts of development candidates to support investigational and clinical studies.
Your job and key responsibilities
Development, optimisation and the scale up of chemical processes to enable multi-kg amounts of development compounds to be produced safely under full GMP on time to support clinical studies. Further development of chemical processes already implemented in process development and design of 2nd generation synthetic procedures
We are seeking a highly motivated and expert medicinal chemist to join the department of Medicinal Chemistry. As an outstanding medicinal chemist with documented results, you can become an integral member of a world-class medicinal chemistry team and help to drive innovation in small molecule drug discovery and join our quest for new medicines to treat Central Nervous System (CNS) diseases.
As a Principal Scientist in Medicinal Chemistry you will be involved in all aspects of the medicinal chemistry value chain, and expected to provide scientific oversight and accept accountability of medicinal chemistry activities in assigned projects. You will be expected to manage a multi-disciplinary team of scientists within ongoing hit to tool and lead optimization projects and promote a culture that embraces open scientific debate and agile, accountable decision-making.
The focus of The Novo Nordisk Foundation Center for Biosustainability (DTU Biosustain) is to develop cell factories for producing chemicals and other products in a sustainable way. The list of things that can be made by engineered cell factories includes biofuels, bioplastics, drugs, food supplements and much more.
We are looking for an enthusiastic and skilled data scientist for The Novo Nordisk Foundation Center for Biosustainability (DTU Biosustain). This person will be part of the Data Science and Automation Unit of the Center and will work closely with both technical teams (software engineering, data management, other data scientists) and with application-oriented teams working on developing cell factories for sustainable production of chemicals and proteins.
AJ Vaccines A/S, Copenhagen
We are looking for a highly qualified downstream scientist with experience from the pharmaceutical industry to join the Pilot plant/API Support Unit.
You will be responsible for running lab scale / pilot scale downstreams for support and optimization of the productions. We therefore seek an experienced chemist with a biochemical/protein chemical background. The job will also entail a good understanding of analyses as well as data processing. Presently, the pilot scale downstream process plays a central role in the introduction of a new upstream technology in the polio production. Resolving issues in the production demands an understanding of pharmaceutical production to be able to create necessary and realistic solutions.
AGC Biologics A/S, Søborg
At AGC Biologics, we work with the development of biopharmaceutical manufacturing processes and GMP manufacturing of biopharmaceutical proteins for both clinical testing and marketing. Since we are a contract manufacturing organization, a high level of service to our clients is in focus.
As a Laborant (Technician) in QC Chemistry, you will primarily be working with HPLC analysis, such as RP-HPLC, SE-HPLC, HI-HPLC, cIEX-HPLC, and CE-SDS and iCIEF analysis. We perform both analyzes of the production and stability studies of the API, and validation of analytical methods for clinical phase I/II and III. All work is performed under cGMP. You will be responsible for equipment in QC and should help to ensure that existing procedures and guidelines are followed.
Carlsberg Breweries A/S, Copenhagen
Carlsberg A/S has one opening for a two-year Project Scientist position to work with abiotic stress in the Raw materials Group at the Carlsberg Research Laboratory (CRL).
As Project Scientist you will:
- Be part of a team breeding barley for the future.
- Participate with and interact in a project group consisting of Carlsberg Research Laboratory and world leading academic partners.
- Work on mineral transporters involved in soil-plant uptake and transport within the plant
You will be part of a world leading global company that provides an experienced international team and excellent research facilities. Our research group applies a range of technologies and advanced approaches in developing the future elite barley.
Gubra ApS, Hørsholm
At Gubra we are looking for a talented and dedicated research scientist for our NASH-histopathology group. The priority of the group is to deliver high quality histological data in an efficient manner within NASH/NAFLD, diabetes, obesity and related metabolic disorders.
We are looking for a competent scientist with great histological skills and biological understanding; a colleague who can navigate and collaborate in an energetic organization and help drive our research activities forward.
Your tasks as a Histology Research Scientist are varied, but will include:
- Conduction of internal discovery and external contract research activities
- Pathological/histological scoring and quantitative analysis of liver sections
- Coordinating and supporting experiments in the laboratory
Maersk Supply Service, Lyngby
Do you have a talent for recycling and waste management? We are looking for an experienced candidate with a good track record of North Sea decommissioning activities.
The Recycling and Waste Management Engineer will be one of Maersk Decom´s specialists and a technical resource for decommissioning and abandonment activities, ensuring the that we know what we are going to handle, that facilities, equipment and materials recycling values are maximized and waste are handled as required.
The Recycling and Waste Management Engineer will be responsible; to engineer and document safe, reliable and efficient recycling and waste management solutions, assist innovation of new methods and tools to enhance quality and efficiency, concept studies and prepare technical input for tenders based on input from specialists, collaboration partners and subcontractors.
Maersk Supply Service, Lyngby
Do you have a talent for flushing and cleaning operations? We are looking for an experienced candidate with a good track record of North Sea decommissioning activities.
The Flushing and Cleaning Engineer will be one of Maersk Decom´s specialists and a technical resource for decommissioning and abandonment activities, ensuring the that adequately trenched pipelines are cleaned and preserved as required to be left on site and other facilities are cleaned and flushed to facilitate disconnection, dismantling and recycling.
The Flushing and Cleaning Engineer will be responsible; to engineer and document safe, reliable and efficient flushing and cleaning solutions, assist innovation of new methods and tools to enhance quality and efficiency, concept studies and prepare technical input for tenders based on input from specialists, and collaboration partners and subcontractors.
The Novo Nordisk Foundation Center for Biosustainability at DTU, invites applications for a number of positions as Laboratory Technicians (Laborant) for its CHO production cell line development research project.
DTU Biosustain is an international research center of excellence developing next generation cell factories and bioprocesses for sustainable production of high-value chemical compounds as well as protein-based products.
The Laboratory Technicians will report to the Director CHO Cell Line Development and responsibilities will include:
- Ensuring the smooth operation of the protein chemistry facilities, i.e., Äkta Pure cleaning and general maintenance
- Participation in the process of planning experiments
Siemens Gamesa Renewable Energy A/S, Kgs. Lyngby
For our team of surface treatment specialists in the Siemens Gamesa Validation Means Management section that resides on the DTU campus in Lyngby, we are now looking for a new Coating Specialist colleague.
In this role, you will be part of our R&D department (Corporate Technology) that forms the core of our technological leadership, and building values like excellence, innovation and responsibility.
What are my responsibilities?
- Technical responsibility for specifying and validating coating systems or deliver the needed know-how for the surface treatment specifications.
- Ensuring compliance between coating systems, production standards and guidelines.
- Specification of technical requirements to existing and future coating systems for steel and composite components
Vi søger en laborant eller laboratorietekniker til en fast stilling i Department of Bioanalysis. Afdelingen har ansvar for at udvikle og validere bioanalysemetoder til kvantitativ bestemmelse af lægemidler og metabolitter i biologiske prøver, samt at analysere prøver fra såvel non-kliniske som kliniske studier. Vi er i dag 15 medarbejdere i afdelingen, hvor laboranter og akademikere arbejder tæt sammen i en travl, men inspirerende hverdag. Vi kan tilbyde nye og moderne laboratorier - og kontorfaciliteter, og du vil opleve en positiv atmosfære og godt kollegialt samarbejde i afdelingen.
Din primære opgave bliver at analysere biologiske prøver fra non-kliniske og kliniske studier. Metodeudvikling og metodevalidering omfatter ud over det praktiske arbejde skrivning af protokoller, udarbejdelse af metode SOP’er samt rapportering af valideringsdata. Arbejdet udføres i henhold til GLP /GCP og efter FDA og EMA guidance.
We are looking for a Bioanalytical Research Scientist/Principal Scientist with experience in LC-MS based bioanalysis of small molecule drugs.
Your key responsibilities will be Bioanalytical method development, validation and quantitative determination of drugs in biological matrices from non-clinical and clinical studies. You will also be involved in project teams, representing the Department of Bioanalysis and/or the Non-Clinical Safety Research area, holding the primary responsibility to drive the project forward with focus on ADME area and carry out decisions made by the project team. As Research Scientist/Principal Scientist, you will be guiding and sparring with the laboratory technicians regarding daily analytical work and scientific issues.
The cleanroom facility (DTU Danchip) at the Technical University of Denmark seeks a candidate for a one year position as Process Engineer/Physicist in cleanroom nanofabrication.
DTU Danchip is one of the largest facilities in Northern Europe for top-down micro- and nanotechnology with a broad spectrum of advanced processing and measurement equipment supporting research, teaching and production activities in the fields of MEMS, optical communication, quantum technology, and biochemistry (lab on a chip).
We are seeking a candidate in the field of thin-film deposition, including physical vapor deposition (sputtering and evaporation), low pressure chemical vapor deposition, and furnace processing in general. The main tasks will be to develop and maintain processes and equipment in a close collaboration with the other process specialists and technicians in the team.
AGC Biologics A/S, Søborg
Do you want to lead a large biologics drug substance process development organization with state of the art laboratories? Do you want to play a key role in developing AGC Biologics technology platform and service offerings? Do you want to play a key role in bringing new products to market?
Then join AGC Biologics as VP Process Development and become part of an international and modern organization that delivers biopharmaceutical development and manufacturing right and on time.
The Vice President (VP) of Process Development (PD) will be responsible for overseeing the development and commercialization of biologic drug candidates. The VP will provide leadership to an organization responsible for Cell Line Development (CLD), Upstream Process Development (UPD), Downstream Process Development (DPD), Analytical Development (AD), and Process Transfer (PT).
AGC Biologics A/S, Søborg
Would you like to participate in scientific innovation that makes a difference in patients’ lives? And do you have cell culture experience?
You will be part of a team of scientists and technicians developing mammalian and microbial processes. We perform studies such as media/feed optimization, process optimization by Design of Experiment in shake flasks and bioreactors, and down-scaling to define process parameter limits and process robustness. The department is also responsible for cell line development, cell banking under GMP regulations and manufacturing support. We work closely together as a team, and your main task will to be conduct experiments and practical laboratory work.
At AGC, you will get great opportunities to work with a wide array of tasks and challenges, and you will get experience with our various departments.
Do you want to put your data science skills into use in campaigning for clean air?
GREENPEACE, København S
Is it your dream to be working with optimisation and support?
Novo Nordisk, Bagsværd