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This position will oversee purification development for both early and late stage processes including process development, optimization, characterization and technology transfer to...
This role serves as a close business partner and facilitator of regulatory activities and is expected to contribute to developing sound regulatory strategies globally. The role...
Provides Quality oversight for Bicycle’s development programs, ensuring compliance with applicable ICH GCP and GLP standards and global regulations. As an integral member of the...
You will play a pivotal role in ensuring the quality and compliance of Investigational Medicinal Products (IMPs) through your leadership and guidance of supplier management teams....
The activities of your team will concentrate on the identification of novel therapeutic concepts in immune regulation and tolerance with the potential to lead to transformative...
Develops and communicates CMC regulatory strategies that are in alignment with project goals and timelines. This includes formulating the global CMC strategy for the Global...
Perform qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product; Recommend the analytical characterization...
Accountable for new business generation, sales growth and customer acquisition where you will be supplying products into three clearly defined markets; Life Sciences...
Conduct pharamacokinetic data analysis, provide scientific interpretation of study results, perform clinical report writing, and independently handle interactions with clients...
You lead a team of research associates and scientists dedicated to developing and validating (bio)assays for release and stability testing of antibody products. You will focus on...
Lead Scientific Strategy: Direct the scientific strategy for the project within Global Antigen Design, operating within a fast-paced and agile environment to drive innovation and...
Performing a range of analytical experiments using different separation and characterisation methods (IEC, SEC, RP, HIC, HILIC, CE-SDS, LC-MS and LC-MS/MS); Experience in...
You provide leadership to the PDQA QP Team and actively contribute to the quality oversight of the Jazz product development pipeline through clinical phases from a science-led...
You will be responsible for the development and optimization of the manufacturing processes from synthesis to the final API in collaboration with our customers as well as internal...
Closely work with subject matter experts to develop a plan to deliver on the medicine vision for the potential targeted radiopharmaceutical drug candidate; Lead the...
You will be key in leading a team (10-15 HC) of highly talented scientists and researchers in a matrix organization. You will shape, support, develop and optimize the team...
Provide visionary leadership for the Quality Control function, defining and executing the strategic direction for quality control activities across the Aachen Site, being Part of...
Write and review clinical (and nonclinical) documents for regulatory submissions in the EU and US, such as Module 2.5, 2.7, 2.4, 2.6, integrated summaries of efficacy/safety...
Provision of scientific and technical leadership to multidisciplinary teams to achieve corporate goals for challenging research projects within biologics early drug development...
This pivotal role is responsible for delivering an effective testing and analytical service to ensure that our plant's products consistently meet specified standards. As an...
Lead the teams of ESO Quality Assurance Managers, the Sandoz New Product Supply & Launch (NPS&L) QA team, and the ESO EU Release hubs in various locations around the globe within...
Lead and mentor a team of Analytical Subject Matter Experts for both biologics and small molecule drug products fostering innovation and technical excellence; Support the...
Lead the creation and execution of global brand plans for our microbiology range globally, and for all market segments, from developing to developed settings, ensuring alignment...
You will be responsible for the comprehensive execution and oversight of the Product Development Process (PDP) for a given project within our R&D group. In the role, you will drive...
The role will provide leadership and strategic direction for assigned programs, ensuring the successful implementation of the quality strategy and/or quality plans to foster a...
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...
Work with country or global teams to plan and implement Phase IV GMA-sponsored clinical trials, interventional or non-interventional. This includes all aspects of study management...
Contribute to study protocol development including study concept, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate,...
Generate impactful biochemical, biophysical, and structural biology data with human relevance to support our small molecule- and genetic medicine projects. Explore target...
You will support the professional development of their reports, ensure that robust Medical Affairs plans are developed and executed on time, on budget, and to strategy, and foster...
Develops a strategy for external manufacturing of Teva’s products and manage its implementation, in collaboration with TGO leadership and commercial units. Establishes and...
Oversee Santhera's global Pharmacovigilance (PV) system, ensuring compliance with regulations and managing PV vendors and activities; Ensure Santhera meets its obligations as a...
This role is pivotal in driving biomarker strategies, early clinical development plans, and providing scientific expertise and strategic guidance. The successful candidate will...
Lead and provide technical expertise in the planning and execution of IVD assay development projects, acting as a knowledge expert for quantitative PCR (qPCR) diagnostic systems...
You will provide leadership for all Small Molecule QC laboratories related to Lonza’s Visp site. You will ensure adequate resources (staff, laboratory and instrumentation) to...
Responsible for providing operational support for the planning, management, support and execution of regulatory activities for PTC drug products (clinical and commercial) within...
Leading the Clinical Pharmacology program and strategy of assigned programs by defining and implementing the Clinical Pharmacology Plan of NCE/NBE to support the registration...
Designs and delivers innovative & collaborative medical affairs projects, has a significant role in developing and driving the Medical Affairs Plan, operates as a medical reviewer...
Responsible for the planning and organization of formulation and process development of various modalities - with a focus on parenteral formulation containing nanoparticular...
Lead (Co-lead) the study teams to develop a cross-functional, integrated study implementation plan including creation of initial study budget, study kick-off and team meetings....
This is a leadership role that requires a scientific visionary with deep expertise in oncology, immunology, and data-driven target discovery, coupled with strong team management...
A managerial position responsible to ensure that assigned Quality Management System activities are managed in compliance with regulations and company policies and in accordance...
The core responsibility of the Medical Director is to lead the local medical department, be a part of pan-European R&D projects and work closely with other medical departments in...
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...
In this role, you will lead a team of five quality officers, providing direction and coaching to elevate both the quality of work and the motivation of your team. We are seeking a...
You will have overall responsibility for providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials....
Lead and conduct research to develop and evaluate mRNA-based vaccines against infectious pathogens with a focus on optimizing vaccine performance and longevity of responses...
Providing clinical operations leadership and expertise on the Evidence Generation Team and in development of the Evidence Generation Plan (EGP) and PT as required. Global clinical...
Responsible for supporting the overall CMC strategies within projects, and manage project teams for the development of small molecule pharmaceuticals. Accountability to lead teams...
This position allows you to lead and execute process optimization projects, driving improvements in manufacturing process performance and efficiency. By utilizing your scientific...
You will be responsible for overseeing all aspects of Quality for Research and Development of Aesthetic Filler products, including Design Controls, Risk Management, Design Changes...
Lead the Quality function team to perform batch review, testing and release activities to certify product in compliance with specifications and procedures, ensuring timely...
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 play a critical role in all aspects of ADME (absorption, distribution, metabolism and excretion) covering multiple modalities across drug discovery and development. You...
Ensure compilation, submission and approval of CTAs and INDs for all clinical trial-related regulatory activities, maintaining these throughout the development phases. Provide...