Senior Formulation Specialist [rekrutacja online]
Location: Pabianice
Responsibilities
- Literature searching and review, , performing risk assessment for formulation/process development, conducting experimental design and execution of lab scale and pilot scale developmental batches to support the final formulation and processes.
- Regular cooperation with internal (i.e. production, quality, engineering, validation, project management) and external (clients, vendors, consultants) customers to achieve project targets.
- Develops, troubleshoots, and optimizes DPI processes from lab to pilot scale (GMP). Manufactures beq/regulatory/validation batches. Assists in the scale-up and transfer of processes from pilot to commercial scale.
- Clearly documents all data generated and report all research work performed - includes creation and documentation of study and experimental protocol, development of experimental process, identification and corrections of developmental and manufacturing issues/problems/ observations.
- Generates GMP and Regulatory documents
Requirements
- Prior experience (minimum 5 years) in the development of inhaled drug products (DPI) formulation. Knowledge of pharmaceutical materials science as well as physical and analytical characterisation techniques.
- Excellent knowledge of industry guidance relevant to inhalation and prior experience in a GMP environment
- Experience in the use of QBD principles and tools (such as statistical software, in vitro/in vitro correlation techniques)
- A high sense of urgency, attention to details and results orientation is required. High level of communication and presentation skills
- Hands-on experience in tech-transfer in DPI's processing from the R&D lab scale to pilot/production scale in GMP area.
- Working knowledge of applicable global regulatory requirements. Strong knowledge of EMA requirements, understanding of other regulators.
