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Responsible in full for adherence with the quality agreement provisions; Responsible to ensure all deviations are appropriately investigated and recorded; Responsible to drive CAPA...
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...
Develop and execute sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle. Collaborate with cross...
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 the safety profile of the assigned product(s) during clinical development including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease...
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...
You will conduct activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risk for the assigned products throughout...
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...
As a successful candidate, you will take the role of Team Leader In vitro Laboratory a team of 2-4 scientists engaged in drug discovery projects for biotech and pharma companies...
This position supports process development, regulatory interactions/submissions, and clinical and commercial manufacturing. The role also oversees early access and commercial label...
You will oversee the planning, organizing, directing, and evaluating of routine external QC activities, including stability and project deliverables of external QC laboratories....
Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient...
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...
Engaging in high-quality peer-to-peer scientific dialog with key European Thought Leaders (TLs) in Neurology focused on pre- and peri-launch period. Collaborates with European...
Analysis of new chemical entities using analytical and preparative liquid and supercritical fluid chromatography techniques. Preparation of samples, reagents, solutions and...
Act as the quality lead for all Externally Sponsor Research, Non-interventional studies, Early Access Programs, Name Patient Programs and other non traditional clinical studies....
Developing a multi-year category strategy aligned with relevant stakeholders, recognizing the strategic importance of our External Manufacturing Operations portfolio; Implementing...
You are accountable for managing all analytic related activities of Drug Product development incl. release and stability-testing, characterization of the API, method-development,...
Le titulaire du poste a pour mission de participer au diagnostic, au traitement et à la prévention des maladies, ainsi qu'à la prestation de conseils, en effectuant ou en...
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...
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...
Proactively identify possibilities to optimize case management, case management vendor oversight and process improvements within SOBI. Support the Global PV Case Management Lead in...
Develop and validate ligand-binding assays to support bioanalysis (pharmacokinetics, biomarkers, immunogenicity assessment) for preclinical and clinical studies; Oversee and...
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...
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...
The Principal Research Scientist will lead a team of chemists designing and synthesizing small molecules aimed at identifying and advancing promising low dose leads. They will be...