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,...
The core responsibility of the role is to provide Global Quality Assurance leadership and oversight of global pharmacovigilance systems. Globally responsible for establishing a...
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...
Ensure quality checking or approval of documents needed to manufacture and release batches such as the master batch records, related documents (instructions, forms, development...
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...
Provide technical and scientific leadership to the Drug Product Internal and External manufacturing network through partnerships with global functions and third-party Commercial...
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...
Independently design, perform and analyze in vitro experiments to generate impactful data to support our pre-clinical assets such as small molecules, biologics or RNA-modulating...
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...
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...
Lead global regulatory operations to achieve excellence in compliance and quality across all global projects, staying ahead with up-to-date knowledge on FDA, GCP, and ICH...
In this role, you will contribute to the characterization of biopharmaceutical molecules, supporting client projects through advanced analytical techniques. Perform LC-MS analyses...