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Lead and manage a scientific team of up to 15 Hcs, including experts in fields of oral formulation, pulmonary drug delivery, long acting and modified release dosage forms...
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...
Play a key role in executing Medical Affairs Evidence Generation projects for both approved and pipeline products. This position will be responsible for overseeing a molecule...
Leads a team of Group Heads and Scientists. Ensures process development stages for liquid and lyophilized parenteral drug products (DP) of biologics (e.g. monoclonal antibodies,...
This role will be responsible for provision of analytical methods, data and information using analytical techniques in supporting site manufacturing processes and network projects...
You will be responsible to develop & maintain the strategy of Global Quality with respect to Analytical Technology and harmonization by leading the Global Analytical Science and...
ProQR is looking for an allround nonclinical subject matter expert who will be responsible for the design and monitoring in vivo studies (through selected vendors), evaluation of...
You will lead multiple pharmaceutical development projects to ensure effective collaboration between internal & external stakeholders to meet the objectives of Hovione and our...
Planning, performing and interpreting metabolite profiling studies up to and including human ADME studies for regulatory submissions, including MIST evaluation. This will be...
You will lead research programs in collaboration with internal and external partners focused on the development of novel drug candidates for the treatment of chronic liver...
Provide independent and high-quality scientific advice and expertise to support the Executive Director in developing the overall vision and strategy necessary for the agency to...
Independently design, perform and analyze in vitro experiments to generate impactful data to support our pre-clinical assets such as small molecules, biologics or RNA-modulating...
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...
Responsible for managing daily activities related to quality, including campaign preparation, change control, deviation & CAPA management, and process monitoring. Ensures...
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...