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Executing and managing all tasks of the MS&T organizational unit. Improving existing production procedures with the aim of achieving better results, increasing robustness, and...
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...
Provide technical and scientific leadership to the Drug Product Internal and External manufacturing network through partnerships with global functions and third-party Commercial...
In this role, you’ll be responsible for overseeing the scale-up of fermentation processes from lab to commercial scale, and you will be instrumental in leading our plant start-up...
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...
You will manage PV staff and provide oversight to PV activities, workflow, processes, and procedures. You are also responsible for clinical PV (CPV) and post-marketing PV service...
You will manage uninterrupted supply of Gilead’s clinical and commercial products through execution of manufacturing campaigns within our global external contract manufacturing...
You own your assigned projects, are responsible for the projects progress and ensures that everything required to make it happen is available and/or performed. You communicate with...
Design, plan, perform and document scientific experiments as well as analysis and interpretation of the results to drive development and validation of analytical methods for solid...
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 will oversee batch release quality and compliance across internal sites and third-party maufacturers, ensuring all products (pharmaceutical and non-pharmaceutical products)...
Drug product development according to assigned project workpackages and in alignment with project strategy, objectives and timelines; Leading of Drug Product (DP) development...
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,...
Provide regulatory support for existing Drug Substances and Drug Products by preparing and maintaining the appropriate regulatory submission documentation needed to obtain...
Co-ordinate experiments with CRO’s; Review, interpret and report data in support of drug discovery projects; Present data at multifunctional project teams; Work collaboratively...
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...
She/He will lead the EMEA medical community providing medical guidance and expertise across organization and externally. Define the EMEA medical strategy in close collaboration...
Ensure regular Quality interaction with other Departments including Validation, Manufacturing, Quality Control and Maintenance and represent QA Manufacturing as Risk Champion....
The primary responsibility of the Director - Medical Neuroscience is to provide expert medical support to all aspects of the local business in Neuroscience, with a specific focus...
You will participate in innovation projects as the quality representative, being accountable for the quality deliverables of the project. Thus, you will ensure product quality...
They will lead the Chemistry, Manufacturing and Controls (CMC) organization, encompassing Analytical Chemistry and Formulations, while working cross functionally with Regulatory...
Manage Clinical Safety activities and multiple large programs. Oversee clinical safety case management and aggregate reporting responsibilities to ensure client needs are fulfilled...
Owning all quality related responsibilities for the CQV Lifecycle Program for new facilities, equipment and utilities related to the GMP manufacturing of biologics & APIs;...
Developing the medical marketing content strategy of the brand; Effectively creating, managing, and executing educational and promotional marketing programs, and communicational...
Provide support to the reference standards team through the synthesis, purification and isolation of critical process and degradation impurities. Impurities will be synthesis to a...
The candidate will be working on the development of container closure systems (CCS) and manufacturing processes within the PDS&T organization at AbbVie...
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...
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...
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...
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...