• Design and execute development studies to support GMP process development for human autologous gene-modified HSC cellular products
• Perform studies to improve the identity, purity and potency of candidate autologous gene-modified HSC cellular products
• Evaluate new technologies to ensure safety and reproducibility of cellular drug product
• Perform clinical cell manufacturing processes in accordance with cGMP.
• Author and review relevant documentation (SOPs, batch records, technical development reports) for cell manufacturing processes
• Perform analytical assays including ddPCR; flow cytometry; cell- and CFU- based assays
• Analyze, collate, and present cell manufacturing process development results and experimental data within department and externally, as required
• Perform Technical Transfer of manufacturing processes and test methods in and out of department
• Perform routine maintenance on scientific instrumentation, as required. Liaise with instrument engineers for repair and maintenance of equipment
• Ensure inventories are maintained for materials, reagents, consumables and samples
• Ensure compliance with local, state and federal regulations, safety standards, laws and policies as well as CSL’s policies and directives
• PhD or MS in a relevant science or engineering related discipline, or equivalent years of experience in Gene or Cell Therapy-related field.
• 3+ years of experience in an academic or industry research setting.
• Experience in the field of cell therapy and/or viral vector gene delivery
• Experience with clinical-scale manufacture of primary human cells
• Experience in biological assays, cell culture, flow cytometry, immunophenotyping, ELISA, PCR.
• Experience in a regulated laboratory preferred
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.
Do work that matters at CSL Behring!