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 / Biotherapeutics (Recombinant proteins)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Experimental study design and execution, physicochemical assays, formulation development, aseptic processing, stability trial management, data acquisition and analysis, regulatory documentation, change control and validation, risk assessment, laboratory equipment maintenance, material procurement and storage
Preferred skills
None stated
Technologies
None stated
Responsibilities
Conduct experimental studies on formulation, aseptic processing, dispensing, testing, storage, and stability trials; ensure safety standards compliance; maintain laboratory facilities and equipment; manage procurement and storage of active materials and chemicals; lead change controls, process investigations, and validation activities; document and report studies per quality and regulatory guidelines
Seniority
Mid-level (3+ years experience)
