Job Description
Job Description
Main Responsibilities
Supports or leads (with minimal guidance) new product introductions to the site by conducting process and equipment comparisons, new raw materials introduction, development studies, clinical supplies manufacturing, cleaning processes development/ validation and training of technicians as required. Authors PPQ protocols, reports and other associated documentation related to a new product introduction. Expected to have a working knowledge of product development, scale-up and technical transfer, key supporting documentation and associated regulatory requirements. Demonstrates strength in technical writing for change request, PPQ reports and CMC sections. Is involved in/supports the design and execution of small/ full scale experiments using appropriate methodology and/or simulations for products/ processes to evaluate the impact of proposed changes to validated equipment/ processes. Proactively identify solutions with support from seniors or dir...
Main Responsibilities
Supports or leads (with minimal guidance) new product introductions to the site by conducting process and equipment comparisons, new raw materials introduction, development studies, clinical supplies manufacturing, cleaning processes development/ validation and training of technicians as required. Authors PPQ protocols, reports and other associated documentation related to a new product introduction. Expected to have a working knowledge of product development, scale-up and technical transfer, key supporting documentation and associated regulatory requirements. Demonstrates strength in technical writing for change request, PPQ reports and CMC sections. Is involved in/supports the design and execution of small/ full scale experiments using appropriate methodology and/or simulations for products/ processes to evaluate the impact of proposed changes to validated equipment/ processes. Proactively identify solutions with support from seniors or dir...
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