R&D Scientist, Cellular Manufacturing

About CSL

With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

The R&D Scientist-Cellular Manufacturing will be responsible for assay and process development for clinical cell manufacturing processes. They will develop, validate, and standardize cell manufacturing methods, transfer methods internally and externally where required, perform routine assays in support of cell manufacturing activities, release tests, and/or patient sample analysis where required and report results, and maintain laboratory quality systems and records of cell manufacturing results.

• Perform process development experiments to optimize cell manufacturing processes and perform clinical cell manufacturing processes in accordance with cGMP.
• Drafting of Test Procedures and Standard Operating Procedures (SOP) for cell manufacturing processes
• Perform cellular and molecular analytical assays including qPCR; RT-qPCR; flow cytometry; cell- and CFU- based assays
• Document cell manufacturing process and test results within batch records, and report results as required
• Analyze, collate, and present cell manufacturing process development results and experimental data, within department and externally, as required
• Perform Technical Transfer of methods in and out of department
• Perform routine maintenance on scientific instrumentation, as required. Liaise with instrument engineers for repair and maintenance of equipment
• Perform quality control testing of items, as required
• 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 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 biological assays, cell culture, flow cytometry, immunophenotyping, ELISA, PCR.
• cGMP experience
• Experience in the field of gene therapy and viral vector gene delivery
• Outstanding verbal and written communication skills
• Well organized, able to plan work appropriately.
• Attention to detail. Mechanical aptitude and problem-solving skills.
• Ability to work effectively in a team and independently
• Understanding of regulatory requirements in drug development.
• Good working knowledge of Word Processing, Spreadsheets, and general PC familiarity and usage.