Principal Scientist Cmc Analytical Development

Report to: Analytical Development Lead 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...

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...

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx is translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx’s first...

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...

severe auto‐immune diseases. Report to: Head of Dossier Development Key Accountabilities and Responsibilities: Contributes to the CMC development of pre‐clinical, clinical and commercial stage programs in close collaboration with the CMC team members by: - Participate to the authoring and preparing IND, IMPD, scientific briefing documents,...

**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...

Cerba Research provides the highest quality specialized laboratory and diagnostic solutions while leveraging patient data and scientific insight to shape and advance clinical trials. With our global footprint and access to leading regional labs, data, patients, technology, and partnered resources, we support global biotech, pharma, and IVD organizations to...

**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,...

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...

**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,...

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** 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...

We are currently looking for a Patent Attorney to join our Intellectual Property (IP) team. The Patent Attorney closely collaborates with scientific, clinical, BD (business development) and CMC (chemistry, manufacturing and controls) colleagues. He/she will serve as the IP business partner, engaging and coordinating with external counsel as appropriate. In...

Agriculture plays a fundamental role in fulfilling many of humanity's basic needs: food, feed, energy. To support growers and those who take care of our environment, BASF develops innovative solutions for farming, pest control and landscape management - so that we can effectively contribute to improving people's lives and business' demands. Come join us on...