Team Leader (DPI’s R&D) [rekrutacja online]
Location: Pabianice
Responsibilities
- Provide guidance on the development, oversight, and execution of complex formulation and analytical deliverables for the development of inhaled drug products (DPI) using both internal and external resources.
- Responsible for activities leading to formulation and analytical methods development.
- Leads the team in the technical transfer of manufacturing processes from the lab scale into GMP area
- Supplies technical inspiration, leadership and consultation to professional co-workers
- Reviews and approves technical and regulatory documents
- Identifies and independently drives department level improvements
- Coaches and develops maintaining effective and functional team.
Requirements
- Managerial skills and experience (minimum of 5 years) in pharmaceutical development field to establish and maintain effective and functional team
- Prior experience in the development, oversight, building strategies and execution of complex inhaled drug products (DPI) using both internal and external resources.
- Working knowledge of applicable global regulatory requirements.
- Strong knowledge of EMA requirements, understanding of other regulators.
- Working knowledge and prior experience in a GMP environment.
- Possesses strong understanding of fundamentals of inhalation products (DPI) and knowledge of formulation and analytical methods development.
- Knowledge of EHS regulations necessary to run an R&D laboratory
- Experienced in DPI's processing from R&D lab to pilot scale (GMP).
