We bring breakthrough pioneering therapies to patient with life threatening diseases
Celyad is a biopharmaceutical clinical-stage company, specialized in the development and engineering of CAR-T therapies. Our ambition is to develop a unique platform to offer new treatment options to cancer patients, addressing multiple targets, optimizing the signaling domain, and weaponizing the T-Cell.
Celyad unites passionate people who keep on pushing the boundaries of innovation, leveraging unique scientific know-how from Research & Development to Phase III clinical trials, as well as a strong expertise in cell manufacturing and logistics.
While Celyad is headquartered in Mont-Saint-Guibert, close to Brussels, the company is clinically active across Europe and the U.S and we constantly seek to showcase our Research & Development activities in the international area through publication and congress presentation. Consequently, Celyad offers a stimulating working environment with the opportunity to interact with colleagues and stakeholders across the globe involved at each step of the product development process.
At Celyad, we know that every second counts for the patients and their families, and that is what drives us in our work every single day. Ready to take up this challenge?
Great! Celyad is looking for an enthusiastic:
R&D Quality Process Associate (M/F)
The successful candidate will be based in Mont-Saint-Guibert (Belgium) and will report to the R&D Lab Manager (located in Belgium).
Role & Responsibilities
- Main focus of the role is to build an operational excellence culture within R&D
- Overall a preclinical auditing responsibility for the R&D lab, in addition to what the lab delivers on day to day basis
- Ensure a holistic view and control over quality objective during preclinical research mainly focusing on data quality and integrity
- Collaborate internally within R&D to ensure a slow yet steady shift of mindsets towards GLP-like quality standards
- Put into practice corrective actions recommended by external QA auditors
- Ensure lab equipment’s are managed per SOP’s and review service reports
- Set up a tracking system for R&D studies
- Build an R&D training matrix for each R&D function
- Develop an SOP management system for R&D
- Quality review of R&D data records
- Responsible for deviations management and tracking; ensure implementation of corrective actions
- Provide support for managing contracts with external parties
- Set up and customize the Electronic Laboratory Notebook (ELN) for the R&D Team
Qualifications & Experience
- Good knowledge of GLP within the bio-pharmaceuticals environment
- Experience with Advanced Therapy Medicinal Products (ATMPs) is an advantage
- Experience with setting up QA tools (tracking, record) is a must
- Experience within a QA function is highly desired
- Scientific degree in Bioengineering/Industrial Pharmacy/Biomedical Sciences, min. 3-5 years of relevant experience
- Good knowledge of Offices suite including Excel and Access
Skills & Competencies
- Taking the lead
- Demonstrated knowledge of quality systems
- Excellent organizational skills and strong attention to details
- Works precisely as per procedures, rules and regulations
- Creative, thinking outside the box
- Team spirit
- Strong negotiation skills & influential capabilities
- Excellent communicator
- Flexible thinking
- Excellent English and French knowledge (oral and written)
For more information about this position or about the Company, please contact us by email at email@example.com