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2 giorni fa
Job Summary: We are seeking a skilled Formulation Development Specialist to lead the development of formulations and manufacturing processes of Drug Products. The ideal candidate will have a strong background in pharmaceutical formulation development, with expertise in liquid sterile dosage forms.
About the Role: The Formulation Development Specialist will be responsible for developing formulations and manufacturing processes for Drug Products. This will involve collaborating with operations, analytics, engineering, and relevant SMEs to drive development activities.
- Lead Formulation Development: Develop formulations and manufacturing processes for Drug Products, ensuring compliance with ICH guidelines and internal SOPs.
- Support Analytical Method Development: Collaborate with the AS&T team leader to develop and qualify analytical methods for Drug Products.
- Accountability for Deliverables: Ensure timely delivery of formulation and manufacturing process deliverables, including scientific documentation for assigned projects.
- Technical Support: Provide technical support to inspections and Health Authority requests throughout the project life cycle.
Requirements: A PhD in Pharmaceutics or related sciences with a minimum of 3 years of experience in the pharmaceutical/biotech industry, or a Master's degree with a minimum of 5 years of experience. Fluency in English is required, with a desirable knowledge of site language.
Work Experience: Operations Management and Execution, Functional Breadth.
Skills: Experiments Design, Health And Safety (EHS), Laboratory Equipment, Manufacturing Process, Process Simulation, Project Management, SOP (Standard Operating Procedure), Technical Writing.
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