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Senior Formulation Scientist (Respiratory) [rekrutacja online]
Firma: Adamed Pharma S.A. miejsce pracy: Pabianice
Senior Formulation Scientist (Respiratory) [rekrutacja online]
Location: Pabianice
Tasks:
- Literature searching and review, patent searching and interpretation, 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 leading to exhibit batch manufacturing,
- Regular cooperation with internal (i.e. production, quality, engineering, validation, project management) and external (e. consultants) customers to achieve project targets,
- Develops, troubleshoots, and optimizes DPI processes from lab to pilot scale (GMP),
- Manufactures beq/regulatory/validation batches,
- Assists the scale up and transfer of processes from pilot to commercial scale,
- Prepares documentation of all data generated and reports performed research work (including 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
- Minimum five years of experience in formulation development of inhaled drug products (DPI) formulation,
- Knowledge of pharmaceutical materials science as well as physical and analytical characterisation techniques,
- Experience in the use of QBD principles and tools (such as statistical software, in vitro/in vitro correlation techniques),
- 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,
- Excellent knowledge of industry guidance relevant to inhalation and prior experience in a GMP environment,
- A high sense of urgency, attention to detail and results orientation is required. High level of communication and presentation skills
- Higher education (pharmacy, chemistry, etc.),
- Very good commad of English.
We offer
- A chcance to join newly created R&D Respiratory Team,
- Access to state of art technologies and cooperation with international partners,
- Full impact on scope of performed work on project,
- Very good remuneration (base and bonus),
- Benefits (private medical, insurance and others).
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Data dodania: 03-08-2021
Wyświetleń: 232
Wyświetleń: 232