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Serve as a scientific expert and point of contact for the oversight of Immuno-Assay development, qualification/validation to support programs across multiple therapeutic areas. The...
You will play a crucial role in drug product development together with your CMC colleagues and establishing a good collaboration with the CMOs used by Ascendis Pharma. Designing...
Managing the activities of the Microbiological laboratory (incl. raw materials, intermediate and end products testing, deviations, calibration and validation of equipment, method...
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...
Lead and manage a team of scientists and technicians to conduct bioassay, ELISA and SPR experiments in support of biosimilar development programs...
Review and analyze data from clinical trials, post-marketing and other relevant sources for the prompt identification of safety signals. Review and evaluate serious adverse event...
In this role, you will contribute to the characterization of biopharmaceutical molecules, supporting client projects through advanced analytical techniques. Perform LC-MS analyses...
This position is a scientific and strategic position in the DMPK department which is a part of Early Clinical Development -Translational Science (ECD-TS) group in the Patient...
Conduct protein analysis with emphasis of their physical and chemical properties, e.g protein impurities evaluation, glycosylation, molecular mass, amino acid composition etc...
Design, plan, perform and document scientific experiments as well as analyze and interpret the results to drive development and validation of analytical methods for simple and...
The aim of this role is to perform all types of pharmacokinetic and pharmacodynamic analysis (PK/PD) e.g. non-compartmental PK, compartmental and population PK and PK/PD, to...
Microbiology testing when required, ensuring that all support testing is carried out within the required timelines and in compliance with GMP and GLP guidelines. Working with...
Provision of scientific and technical leadership to multidisciplinary teams to achieve corporate goals for challenging research projects within the field of insect cell culture...
You actively contribute to the strategy to become a center of excellence in the development of biologics, small molecules, and medical devices. Design and lead a global...
Design and implementation of innovative algorithms and computational tools for optimization and quantification of mRNAs, leveraging machine learning and AI methodologies...
Lead and manage a team responsible for all aspects of CMC regulatory strategy, planning, and execution across the product lifecycle, including both development and commercial...
Provide scientific expertise and guidance with a focus on cardiomyopathy and inflammation as well as other disease areas depending on project needs; Identify, develop and validate...
The candidate will lead a department of approximately 30 employees covering Drug Substance, Drug Product, Analytical and Clinical Supplies Management and Logistics and is...
Would you like to contribute to the activities of an international organisation working for the protection of public health? Do you have the potential to play a key role in...
Responsible for managing daily activities related to quality, including campaign preparation, change control, deviation & CAPA management, and process monitoring. Ensures...
Responsible to provide effective technical leadership in achieving scientific excellence, planning, co-ordination and delivery of drug product development projects to meet business...
Play a key role supporting the BLA track of a late-stage drug substance (DS) manufacturing process at an external manufacturing partner (CMO) to enable process qualification and...
This position supports process development, regulatory interactions/submissions, and clinical and commercial manufacturing. The role also oversees early access and commercial label...
Develop and implement molecule characterization strategies; Work with team members to support process development teams with high-throughput analytical procedures; Utilize...
Develop and execute EU medical launch readiness plan for assigned products in neurology/psychiatry area. Support to clinical development with input on target product profile, based...
Analysis of new chemical entities using analytical and preparative liquid and supercritical fluid chromatography techniques. Preparation of samples, reagents, solutions and...
You are accountable for managing all analytic related activities of Drug Product development incl. release and stability-testing, characterization of the API, method-development,...
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...
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...
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...
Develop and validate ligand-binding assays to support bioanalysis (pharmacokinetics, biomarkers, immunogenicity assessment) for preclinical and clinical studies; Oversee and...