About the Role
Based at CEVA Santé Animale – Biogenovac (Pays de la Loire), this hands‑on role focuses on developing, optimizing, and scaling downstream purification processes for synthetic RNA/DNA. You will drive chromatography/TFF method development, ensure GMP‑compliant documentation, and lead validation of column and flow‑path reuse while collaborating across R&D, QA, and Manufacturing.
Principal Missions -
- Design, optimize & scale purification processes for synthetic RNA/DNA using advanced chromatography (AEX/CEX, affinity, multimodal, SEC, HIC) and TFF.
- Develop scale‑down models, define CPPs/CQAs, and apply DOE/statistical tools to ensure process robustness.
- Operate & troubleshoot AKTA systems (Pure, Avant, Pilot, Ready); develop methods, gradients, and in‑line monitoring strategies.
- Author and execute CIP/SIP, regeneration, sanitization, and storage protocols for pre‑packed and self‑packed columns.
- Lead column and flow‑path reuse validation, including HETP/asymmetry testing, lifetime studies, pressure‑flow curves, and cleanliness verification.
- Design and implement sterile filtration strategies (0.22 µm), perform integrity testing, and support validation activities.
- Contribute to GMP‑regulated scale‑up, tech transfer, equipment qualification, deviations/CAPAs, and resin lifecycle management.
- Maintain audit‑ready documentation (SOPs, batch records, protocols, study reports) aligned with ALCOA+ and QbD principles.
- Collaborate cross‑functionally with Upstream, QC/Analytical, QA/Validation, Engineering, and Manufacturing to ensure robust, right‑first‑time operations.
Your profile :
Qualifications
- MSc/Engineer or PhD: Bioprocess/biotech/Biochemistry degree
- 3–7+ years hands‑on downstream processing experience
- Expertise in RNA/DNA purification, chromatography & TFF
- Strong command of AKTA method development & troubleshooting
- Experience in column regeneration & reuse validation
- Solid understanding of GMP operations & documentation
- Rigorous, analytical, detail‑driven; excellent technical writing
- Fluent in English; comfortable in cross‑functional, regulated environments
