Principal Scientist Cmc Analytical Development

To further strengthen our CMC team, we are looking for an experienced and motivated CMC scientist/ senior Scientist. The scientist/ senior scientist CMC will play a lead role supporting cell line development, drug substance (DS) manufacturing process development and analytical method development with external manufacturing partners (CMOs) to enable clinical...

Key Accountabilities and Responsibilities: Contributes to the CMC development of pre‐clinical and clinical stage development programs in close collaboration with the CMC team members by: - Drives the development and validation of analytical test methods for large molecules release and stability testing in accordance with the applicable regulatory...

SENIOR SCIENTIST CMC - Biotechnology- GhentWHAT IS OFFERED - Competitive salary package with extensive benefits. - Opportunity to contribute to the development of therapeutic antibodies and make a tangible impact on patient care. - Dynamic work environment within a rapidly growing biotech company. - Collaborative culture that fosters creativity, innovation...

1. PURPOSE OF THE FUNCTION A senior scientist CMC plays a key role supporting Chemistry, Manufacturing and Controls (CMC) development of Argenx drug products, ensuring that projects move forward in time and within budget. He/she drives internal and external efforts with the aim of developing, producing and characterizing these differentiated antibody...

Purpose of the function (Associate) Scientist CMC occupies a supporting role in Chemistry, Manufacturing and Controls (CMC) team for argenx therapeutic antibodies and their life cycle management following commercialization. Reporting Line Director CMC, analytical development Roles and Responsabilities - Follow up on the execution of agreed commercial...

**About us** As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, **Ardena** is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated...

**About us** **Ardena **is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing,...

Report to: CMC project management Leader Key Accountabilities and Responsibilities: - Responsible for achieving project goals, including timelines, budget, and scope. - Translate the scientific strategy into a CMC project plan with support of the CMC leads for one or more drug development programs/projects, visualising timelines and dependencies between...

Key Accountabilities and Responsibilities: Leads the CMC Regulatory Affairs function within post-marketing CMC. Provides strategic leadership to support development and execution of regulatory strategies for marketed products in the US, EU, Japan and roll-out to other territories world-wide. Critical to this role are strong CMC regulatory strategy and...

The Head of CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs will lead and manage a team responsible for all aspects of CMC regulatory strategy, planning, and execution across the product lifecycle, including both development and commercial phases. This role plays a critical part in ensuring compliance with global regulatory requirements while...

**About us** **Ardena **is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing,...

**About us** As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, **Ardena** is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated...

**About us** As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, **Ardena** is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated...

**Job description **Biostatistics & Bioinformatics scientist** **Who we are** BioLizard is a consultancy company providing bioinformatics, data science and data management solutions for our customers in biotech, pharma and diagnostics. Typically, a lizard adjusts to its surroundings. That is exactly what we do: we adapt to our customers’ data...

argenx is a fast-growing clinical-stage biopharmaceutical company developing innovative potential therapies to help improve the lives of people suffering from severe autoimmune diseases. Our global team is committed to living by our values of collaboration, empowerment, humility, innovation and excellence. As we continue to expand our therapeutic franchises,...

**About us** **Ardena **is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing,...

Operating under an outsourced model, argenx collaborates with bioanalytical vendors. The Senior Scientist will serve as the representative of the Bioanalytical team within one or multiple project teams, fostering close collaboration with internal and external stakeholders. Responsibilities include implementing bioanalytical strategies and contributing to...

US East Coast based Who we are BioLizard is a growing consultancy company providing bioinformatics and data science solutions for our customers in biotech, pharma and diagnostics. Typically, a lizard adjusts to its surroundings. That is exactly what we do, we adapt to our customers’ data environment! The research field is rapidly becoming more...

For the expansion of our Clinical team, argenx is looking for a Clinical Scientist who directs the planning and implementation of clinical programs to meet corporate and clinical research goals. He/she will be the primary clinical/scientific contact for one or multiple clinical studies and provides clinical research expertise within the cross-functional...

For the expansion of our Clinical team, argenx is looking for a Clinical Scientist who directs the planning and implementation of clinical programs to meet corporate and clinical research goals. He/she will be the primary clinical/scientific contact for one or multiple clinical studies and provides clinical research expertise within the cross-functional...