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To effectively structure, build and lead the UK Oncology Medical Affairs Department, providing guidance and support to the team in defining critical strategies and executing...
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...
Your specific focus area will be design and development of novel assay components that support the required assay sensitivity, specificity, and overall solution robustness to...
Develop and implement molecule characterization strategies; Work with team members to support process development teams with high-throughput analytical procedures; Utilize...
Improve team processes and systems for quality and delivery of work. Technical responsibility for all Research and Development activities assigned. Manage, schedule, costs/budget...
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....
Lead pharmaceutical development projects for drug entities (mAB/protein) at all levels of complexity and new modalities (e.g. ADC, mRNA). Projects will involve QC, different...
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...
Do you have the skills and experience in quality documentation, auditing and process analysis required to play a critical role in fostering a “quality culture” within the...
Perform microbiology, sterilization, biocompatibility, and chemical assessments and evaluations for new product introduction, design changes, and process changes/improvements...
This role is crucial in ensuring that our products meet the highest standards of quality and compliance, supporting our mission to improve the lives of diabetes patients globally...
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...
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...
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...
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...
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...
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...
Leads and manages design and conduct of clinical pharmacology studies of increasing complexity, ensuring study deliverables are met on time, on budget, and with the appropriate...
You lead a group focused on the research in basic mechanisms and development of analytical methods and reagents to support Miltenyi's immunotherapy pipeline from early clinical...
You will use your expertise to develop the strategy to characterize the intracellular interactions of editing oligonucleotides on RNA processing mechanisms, and further investigate...
Plan, organize, perform and document scientific experiments/activities, e.g. the development and qualification of cell-based and bioanalytical assays for functional protein...
Planning and executing live-phase experiments to support a diverse range of immunology-related projects. Utilizing your expertise to run various in vivo disease models, as well as...
The candidate will serve as the bioanalytical lead for one of the argenx compounds, represent the bioanalytical team in one or multiple project teams, and closely collaborate with...
Responsible for developing and maintaining a scientific engagement plan with key opinion leaders in their region to provide comprehensive medical and scientific education to...
This role will be pivotal in integrating quantitative methods to advance the development of innovative therapeutics, including small molecules, antibodies, and antibody-drug...
Execute QA operations in support of and in concert with Senior QA Leadership to drive results, establish objectives and ensure appropriate steps are taken to identify compliance...
Are you an experienced Regulatory Affairs leader with a passion for medical devices? Are you looking for a motivated and diverse department to empower, guide and mentor Applied...
Demonstrating scientific and technical excellence in material science and/or plastic engineering to resolve complex material and process issues, ensuring the quality and integrity...
The position leads the Global Development Team for the Asset and works in partnership with other global asset functions in accordance with Target Product Profiles (TPP) as jointly...
Accountable for external PV vendor development and oversight, including quality, performance and compliance of cases, support budget review and strategies of tasks outsourced to...
In this pivotal role, you'll perform critical Quality Control testing using cutting-edge Bioassay and Microbiology techniques within a GMP testing environment, supporting mRNA...