Scientist - Upstream Cell Culture

Role Purpose

The Expert, Science & Technology – Upstream/Cell Culture is responsible for cell & gene therapy (AAV and LVV) upstream process development, optimization and scaling up/down, process characterization, technology transfer, and GMP manufacturing support.

• Lead/support cross‑functional planning, execution, and documentation of experiments and early manufacturing defining the process and delivery method for clinical/commercial sites.
• Design and execute time‑sensitive experiments/studies; capture data/knowledge to advance products from Research to Development to GMP manufacturing.
• Stay current on novel technologies; apply regulatory expectations to process development strategies; contribute to risk assessments; justify development strategies and experiment designs.
• Apply DOE and QbD to develop/refine/optimise/characterise cell culture and vector production; troubleshoot processes/equipment; conduct studies (e.g., media development, fed‑batch/perfusion bioreactor development, optimisation/scale‑up).
• Support new technology development and continuous improvement.
• Provide process/analytical/characterisation knowledge for gene therapy products and required raw materials.
• Maintain collaboration records with research, analytical development, and pilot scale operations.
• Ensure documentation/reports are accurate and suitable for production, characterization, and regulatory filings.
• Write experimental protocols; develop BOM; execute/document studies per SOPs; review/report data.
• Create/revise SOPs for equipment and process operations.
• Author technical reports and CMC sections for regulatory filings.

• BS in biochemistry/chemical engineering/bioengineering (4–6 years) or MS (2–4) or PhD (0–2).
• Extensive experience producing virus/biologics from mammalian expression systems.
• Hands‑on experience with cell lines, bioreactors, and scale‑down models.
• Organised/systematic approach; ability to multitask and meet tight timelines.
• Knowledge of biopharmaceutical purification processes.
• Proficient in statistics; working knowledge of Design of Experiments (DoE).
• Ability to analyse data for data‑driven decisions; continuous improvement mindset; strong communication/team skills.
• Preferred: knowledge of viral cell/gene therapy and prior AAV & LVV process development experience.

English.