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Develop Manufacturing Industrial Strategic Supply Plans (ISSP) for products throughout their lifecycle; Build and maintain a portfolio of strategic projects related to...
ProQR is looking for a nonclinical subject matter expert with experience in GLP toxicology studies according to regulatory guidelines. The candidate will play an essential role in...
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...
Responsible for overall quality of AbbVie products which may include small molecule pharmaceuticals and/or biologics, combination products to ensure business objectives are met...
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...
Overseeing all process development & manufacturing activities within your department to ensure deadlines are met and projects are completed within the budget. Lead, manage and...
Ensure compilation, submission and approval of CTAs and INDs for all clinical trial-related regulatory activities, maintaining these throughout the development phases. Provide...
This role will be pivotal in integrating quantitative methods to advance the development of innovative therapeutics, including small molecules, antibodies, and antibody-drug...
You will lead and inspire a team of highly skilled managers, scientists, and technical professionals for supporting our mission of making cancer history. Your role is pivotal in...
The candidate will be responsible for overseeing all biochemistry/biophysics activities, managing a team of talented scientists. Provide in-depth biochemical/biophysical...
In this vital role you will be responsible for capturing insights and encouraging collaborations to enhance the generation, use, and dissemination of real-world evidence (RWE)...
Formulate, lead and drive global CMC regulatory strategy for biosimilar projects/products drawing on substantial regulatory expertise with a focus on innovation, maximizing the...
You will possess strong skills in physico-chemical methods related to H/UPLC and CE method development and qualification, large molecule (mAbs) characterization, a mentoring team...
You lead CMO vendor teams for daily operational management and coordinate meetings with UCB multifunctional teams; You participate in CMO selection for new and existing products,...
He/she drives internal and external efforts with the aim of developing, producing and characterizing these therapeutics antibodies for early and late stage clinical programs up to...
You will oversee technical and business operations at designated external manufacturing sites, serving as the primary point of accountability for strategic and tactical activities...
You are responsible for leading and coordinating the outsourcing of drug substance development and manufacturing activities. This critical role ensures optimal supplier...
Ensure regular Quality interaction with other Departments including Validation, Manufacturing, Quality Control and Maintenance and represent QA Manufacturing as Risk Champion....
Primary activities will focus on Medical Monitoring Delivery & PV Support. The medical monitor will independently deliver all medical support required for successful delivery of...
They will lead the Chemistry, Manufacturing and Controls (CMC) organization, encompassing Analytical Chemistry and Formulations, while working cross functionally with Regulatory...
Provides global regulatory leadership of assigned program(s); Develops global regulatory strategies, including risk assessment and mitigation strategies; Participates in strategic...