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Lead the safety strategy of the assigned product(s) during clinical development including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease...
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....
Lead technical inputs in product development and validation activities, including analytical development, process scale-up, process robustness studies, product characterization...
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...
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...
Responsible for supporting the overall CMC strategies within projects, and manage project teams for the development of small molecule pharmaceuticals. Accountability to lead teams...
Lead multi-disciplinary matrix teams on complex projects within your area of scientific expertise, facilitating problem-solving and lessons learned activities. Provide strong...
Lead the planning and integration of Research and Development (R&D) activities at our pharmaceutical manufacturing site. Responsible for ensuring the efficient and effective...
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...
You will oversee the execution of one or more clinical trials across different therapeutic areas and development stages, ensuring high-quality and timely deliverables. Participate...
Ensure compilation, submission and approval of CTAs and INDs for all clinical trial-related regulatory activities, maintaining these throughout the development phases. Provide...
Lead the safety profile of the assigned product(s) during clinical development including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease...
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...
Execute Early Access Program planning: Manage all aspects of EAPs, applying risk management principles; Coordinate with cross-functional teams: Align on strategic priorities...
This position is responsible for working with the physicians and other clinical scientists within Early Clinical Development to provide clinical research support for early phase...
The candidate will be responsible for overseeing all biochemistry/biophysics activities, managing a team of talented scientists. Provide in-depth biochemical/biophysical...
Formulate, lead and drive global CMC regulatory strategy for biosimilar projects/products drawing on substantial regulatory expertise with a focus on innovation, maximizing the...
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...
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...
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)...
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,...
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....