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. Major accountabilities 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. Minimum requirements 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. Language English. #J-18808-Ljbffr Scorpion Therapeutics