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聽 聽 聽
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 聽聽聽聽聽聽聽聽聽聽聽聽聽聽聽聽聽聽聽聽聽聽聽聽聽聽聽聽聽聽
- 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.