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...
Lead technical inputs in product development and validation activities, including analytical development, process scale-up, process robustness studies, product characterization...
You will provide regulatory support and advice for internal and external Customers in line with defined regulatory plans and in response to ad-hoc questions. The role will also...
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...
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...
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...
You will primarily work in therapeutic area specific/functional role as a leader and SME representing GRMW in matrixed stakeholder R&D program teams. This role provides a...
Assist the development and implementation of immunological assays, such as ELISA, virus neutralization assays, ELISPOT, flow cytometry, etc., within the CEPI laboratory networks...
The Head of Quality Management (QM) serves as a key organisational leader, responsible for defining, implementing, and monitoring a risk-based quality management strategy aligned...
The candidate will serve as the bioanalytical lead for one of the argenx compounds, represent the bioanalytical team in one or multiple project teams, and closely collaborate with...
Formulate, lead and drive global CMC regulatory strategy for biosimilar projects/products drawing on substantial regulatory expertise with a focus on innovation, maximizing the...