Do you have proven experience in the evaluation or the preparation of documentation on the quality of substances for pharmaceutical use? Are you able to plan your work effectively...
Provides medical oversight of assigned clinical studies in the duty as a medical monitor. Often serves as primary medical contact for customers for assigned clinical studies;...
You will play a critical role in all aspects of ADME (absorption, distribution, metabolism and excretion) covering multiple modalities across drug discovery and development. You...
As a Senior Scientist in the field of cell and molecular biology, You’ll play a vital role in the Drug Discovery processes based on Structure-Activity Relationship studies or...
To maintain performance indicators on key processes of PV system (KPIs: training, submissions ICSR, PBRER, DSUR, RMP, etc.); To maintain the key tracker to be able to provide an...
As a Lead Scientist in this lab-based role you will deliver technical solutions for the next generation purification processes that meet industry demands. You will design, plan and...
Provide regional regulatory leadership and oversight in delivering high quality and efficient regulatory submissions, approvals, and local labelling for their assigned product(s)...
Design and implement the appropriate DMPK strategy according to the stage and needs of a project; Design experiments, review, interpret and present data at multifunctional project...
The Tech Management Lead Drug Product is responsible for the management of technology transfer of the manufacturing processes of solid and/or parenteral Drug Products for...
You will display your skills in analytical development on one hand, and as positive people manager on the other. Your focus will be to strategically strengthen the area of...
The Qualified Person Commercial Products certifying all manufacturing steps up to the finished product is responsible for ensuring that each finished medicinal product batch has...
Proactively identify possibilities to optimize case management, case management vendor oversight and process improvements within SOBI. Support the Global PV Case Management Lead in...
You will be responsible for supporting the development and execution of the country/regional Medical Affairs strategy and programs that support the development, commercialization...
Ensure the implementation and monitoring of the manufacturing and primary packaging of clinical batches of semi-finished products (oral and injectable forms), i.e. batches intended...
Develop and validate ligand-binding assays to support bioanalysis (pharmacokinetics, biomarkers, immunogenicity assessment) for preclinical and clinical studies; Oversee and...
Develop and execute the IEG plan in line with asset strategy. Provide strategic oversight on evidence generation needs and priorities. Lead cross-functional collaboration for...
You will be responsible for oversight of room and equipment qualification, developing SOPs for new manufacturing processes, collaborating with vendors for equipment procurement,...
Subject Matter Expert for aseptic processes including aseptic filling/stoppering, capping, RABS/isolator technology, material preparation (cleaning and sterilization), primary...
You will be responsible for overseeing the quality control process, managing compliance, conducting risk assessments, and supporting continuous improvement initiatives within the...
Ensure clinical trials are executed according to protocol requirements, trial plans, OGSM, argenx procedures, ICH-GCP, and other applicable regulations. Set expectations...
Lead the safety profile of the assigned product(s) during clinical development including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease...
Key technical leader in USP process technologies, accountable for coordination of technical and laboratory activities in support of technology transfer, continued cGMP...
Developing and maintaining an expert understanding of the safety profile of the assigned products as well as understanding of the relevant strategic context (e.g disease under...