Scientist, Drug Product Formulation Development
Core
Design, execute, and interpret formulation development, drug product, and stability studies for CSL's recombinant product portfolio to support pre-clinical and clinical development, regulatory submissions, and commercial manufacturing.
Role type
Scientist, Drug Product Formulation Development
Builds
Robust, compliant drug product formulations and processes for pre-clinical and early clinical trials
Domain
Pharmaceutical Sciences / Recombinant Therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
physicochemical assays, formulation and drug product development, experimental design, data acquisition and analysis, regulatory compliance documentation, laboratory equipment maintenance, change control and validation, risk assessment, multi-tasking, problem solving
Preferred skills
science-based approaches, innovative technologies, operational excellence, cross-functional collaboration
Technologies
aseptic processing, dispensing/sampling, stability trial management
Responsibilities
Conduct experimental studies on formulation, aseptic processing, testing, storage, and stability trials; ensure safety standards and regulatory compliance; maintain laboratory facilities and equipment; manage procurement and storage of active materials; lead change controls, process investigations, and validation activities; document and report studies per quality guidelines.
Seniority
Mid-level, hands-on IC
