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Provide technical and scientific leadership to the Drug Product Internal and External manufacturing network through partnerships with global functions and third-party Commercial...
The primary focus of this job is to lead and guide the late stage clinical and commercial biologics manufacturing operations (Cell Culture, Purification, and Support Services at...
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...
Lead creation and implementation of medical evidence generation plans and keep overview of progress, timelines, and budgets. Initiate and drive evidence generation projects to fill...
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...
In this role, you will develop and embed a consistent Quality Culture across all affiliates, ensuring that robust quality systems and processes are in place to support Sobi’s...
You will lead the cluster supply chain organization for Alpine, Nordics, Benelux, and Poland markets. Providing direction associated to demand, supply, distribution, customer...
As a Drug Substance Project Lead, you will be responsible for leading development projects, depending on their complexity and phase, from preclinical to commercial launch and life...
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...
Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan...
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...
You will be an integral part of our scientific team, provide essential technical support in our Cambridge lab, lead existing R&D projects and contribute to new ones...
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...
Plan, deliver, and manage the clinical trials from start-up to closure together with the trial team; Ensure oversight, including timelines, budget, and quality throughout the...
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...
Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product...
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...
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...
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,...