R&D Associate Scientist CMC
R&D jobs
Information
Work in a dedicated CMC and Process Development team within the R&D Department which delivers manufacturing process and analytical development data to support regulatory submissions, focused on the Chemistry, Manufacturing and Control section.
Actively design, plan and coordinate studies focused upon product characterization, comparability, process development, process variability, analytical development and set-up of process parameters, including protocol writing, data analysis and report writing.
Under the support of his/her supervisor, create and maintain effective partnerships with internal and external stakeholders overseeing vector manufacturing, analytical development and process transfer to GMP manufacturing, to ensure high probability of technical and regulatory success.
Actively participate in and be fully cognizant of practical laboratory work involving the core activities of the CMC/Process Development team and work closely with technical staff providing guidance in the delivery of experimental readouts.
Become fully knowledgeable concerning activities carried out across Celyad Oncology (including clinical cell production and quality systems) in order to gain experience in CAR T cell manufacturing, process and analytical development.
Ensure that all research studies are compliant with internal guidelines and safety protocols, as well as good traceability of operations, using appropriate records and templates.
Stay tuned on new scientific literature and maintain knowledge concerning relevant new research and new technologies within the scientific field of Celyad Oncology.
Present data to project group and larger multidisciplinary teams.
Maintain open and effective communication with the other R&D teams and the different departments of the company in collaborative projects through means including reports and presentations.
