Regulatory Scientist Atmps

Write, review, and assemble high-quality regulatory submissions, including but not limited to Preparation of IND and IMPD modules EMA/FDA Interactions and CorrespondanceRegulatory Sciences: Participate in the definition and implementation of regulatory strategies for the development of ATMPs Provide support for the preparation of Agency meetings (EU and US)....

Within our Cell Therapy team in Mont-saint-Guibert (Belgium) there is one position immediately available for a Production Technician. ***: **The position**: As a Scientist in Analytical Development, your key responsibilities will be to drive development, optimization, and qualification of new analytical methods and equipment associated with hiPSC-based...

Within our Cell Therapy team in Mont-saint-Guibert (Belgium) there is one position immediately available for a Production Technician. ***: **The position**: As a Scientist in Analytical Development, your key responsibilities will be to drive development, optimization, and qualification of new analytical methods and equipment associated with hiPSC-based...

**Manufacturing Scientist**: **Location** - mont saint guibert, Belgium **Business Sector** - Biotechnology **Job ref** - 22773 **Published** - 5 minutes ago **Title: Manufacturing Scientist**: **Location**: Wallonia, Belgium We are looking for a talented Manufacturing Scientist to join our client's growing team. You will work on the development and...

Responsibilities: Design experiments, qualification, and validation strategy according to scientific and regulatory standards. Autonomously organize and carry out the development, qualification, and validation of analytical methods for the characterization and quality control of investigational products. Ensure scientific assistance to laboratory technicians...

**Responsibilities**: - Design experiments, qualification, and validation strategy according to scientific and regulatory standards. - Autonomously organize and carry out the development, qualification, and validation of analytical methods for the characterization and quality control of investigational products. - Ensure scientific assistance to laboratory...

**NOVADIP-BIOSCIENCES** is an innovative biotech company, based in the Walloon Region (Mont-SaintGuibert), with a strong expertise in the development of novel regenerative medicines. This human-sized structure is a leader in first-in-class treatments for bone defects and bone diseases. If you are sharing our vision of developing life-improving and...

NOVADIP-BIOSCIENCES is an innovative biotech company, based in the Walloon Region (Mont-SaintGuibert), with a strong expertise in the development of novel regenerative medicines. This human-sized structure is a leader in first-in-class treatments for bone defects and bone diseases. If you are sharing our vision of developing life-improving and life-saving...

Within our MSAT team in Mont-saint-Guibert (Belgium) there is one position immediately available for a Process Engineer. ***: **The position**: The Process technology transfer Lead reports to the MSAT Director. He/She acts as a reference expert at the level of the Company in all aspects surrounding the technology, processes and knowledge transfer...

Within our MSAT team in Mont-saint-Guibert (Belgium) there is one position immediately available for a Process Engineer. ***: **The position**: The Process technology transfer Lead reports to the MSAT Director. He/She acts as a reference expert at the level of the Company in all aspects surrounding the technology, processes and knowledge transfer...

The mission of Cellistic/ Ncardia Belgium is to understand human iPSC and developmental biology, and harness this knowledge to develop and manufacture iPSC therapeutics that significantly improve patient outcomes. We are convinced that pluripotent stem cell technology is the key to get better, more efficient treatments to patients faster. To achieve this...

**Responsibilities**: - Manage one or more discovery projects aimed at developing, characterizing and optimizing new therapeutic substances. - Develop, validate and implement new potency bioassay and characterization tests related to the evaluation of new exosome or matrisome-based products. - Design experiments based on regulatory requirements and write...

Responsibilities: Design and lead preclinical research and nonclinical development activities. Design, plan and oversee in vivo pharmacology, safety and toxicology studies Establish and manage collaborative relationships with academic partners and CROs Responsible for developing and documenting study protocols; for data review, analyses, and interpretation;...

Responsibilities: Define the in vitro product characterization strategy of Novadip Biosciences experimental products, mainly the scientific approach leading to definition of the product mode of action and composition. Participate in the definition of the product critical attributes in order to support quality control and stability studies. Design of studies,...

Responsibilities: Manage one or more discovery projects aimed at developing, characterizing and optimizing new therapeutic substances. Develop, validate and implement new potency bioassay and characterization tests related to the evaluation of new exosome or matrisomebased products. Design experiments based on regulatory requirements and write study plans...

**Responsibilities**: - Provide leadership to work on development and continuous improvement of the manufacturing process. - Set-up of process development projects, conduct and follow-up of projects execution, provide timelines, budget and reporting. - Establish process validation plan in accordance with quality requirements and guidelines. - Set-up...

Responsibilities: Provide leadership to work on development and continuous improvement of the manufacturing process. Setup of process development projects, conduct and followup of projects execution, provide timelines, budget and reporting. Establish process validation plan in accordance with quality requirements and guidelines. Setup comparability studies...

**Responsibilities**: - Design and lead preclinical research and nonclinical development activities. - Design, plan and oversee in vivo pharmacology, safety and toxicology studies - Establish and manage collaborative relationships with academic partners and CROs - Responsible for developing and documenting study protocols; for data review, analyses, and...

**Responsibilities**: - Define the in vitro product characterization strategy of Novadip Biosciences experimental products, mainly the scientific approach leading to definition of the product mode of action and composition. - Participate in the definition of the product critical attributes in order to support quality control and stability studies. - Design...