Requirements: English
Company: Cellistic
Region: Mont-Saint-Guibert , Wallonia
Cellistic is an established cell therapy platform provider. We enable therapeutic companies in developing and producing their cell therapy candidates for clinical. We believe that human induced pluripotent stem cell (hiPSC) technology will help get better therapies to patients faster. Cellistic specializes in process development and manufacture of cell therapies based on hiPSC technology. Its focus and expertise in hiPSC reprogramming, differentiation, and expansion protocol development positions the business to be the partner of choice for innovative cell therapy developers to commercialize novel advanced therapies. With this approach we believe more patients will get better treatment, with better safety profile and faster. Come and join us with this important journey. We are an enthusiastic, skilled and committed international team in which everyone has the opportunity to make a decisive contribution.
Responsibilities:
- Conduct release routine and non-routine inspection and analysis of raw materials, starting materials, in-process and finished formulations, according to Standard Operating Procedures (SOPs) & GMP and document results.
- Review data obtained for compliance to specifications (including double checks) and report abnormalities.
- Initiate and follow-up on QC/QMS-related GMP documentation, including CCR, deviations, OOS and CAPA, under supervision.
- Draft and update SOPs and associated QC documents.
- Participating in the daily operational QC activities, incl. but not limited to cleaning program, maintenance of lab equipment, sample reception, registration and storage, environmental monitoring activities.
- Participating in the qualification procedure for incoming raw materials, drafting and revising SPECs and setting up specific release tests.
- Support the Tech Transfer of Analytical methods to QC (under Analytical Development Department supervision).
- Generation of GMP documentation related.
- Perform testing associated to the transfer and validation activities.
- Contact CROs for outsourced testing (organization and preparation of shipments of samples, request, results verification and recording).
Qualifications:
- Master or Bachelor degree in Biotechnology/Applied Biology or equivalent relevant experience.
- Min 5 year experience in molecular Biology and cellular analytical technologies.
- Experience in Flow Cytometry (acquisition procedure, antibody titration, analysis of results, compensations, ).
- Experience in method development and validation.
- Knowledge of GMP.
- Knowledge in the field of IPSCs and immunology is an added value.
Required Skills:
- Focus on quality, compliance and detail
- Be organized, flexible, autonomous and dedicated
- Ability to work in (transversal) teams Strong team spirit
- Excellent interaction & communication skills
- Work precisely per procedures and planning
- Languages: Excellent level of French and very good level of English (oral and written)
- Proficient user of Microsoft Office applications
- Can do attitude
- Problem solver
We offer you a challenging position in a dynamic cell therapy company with room for personal growth and development. We provide a competitive salary package based on your education and experience.