Category

Description

The Role

• Leads complex, multidisciplinary projects including project spend and scope changes to ensure that required deliverables are realized within approved spending limits.
• Develops detailed project plans, budgets and timelines using project management tools such as Microsoft Project, and coordinates and ensures timelines with other departments.
• Closely monitors the status and results of all activities carried out under the project plan(s). Keeps plans up-to-date and ensures discrepancies are being resolved.
• Prepares project status reports by collecting, analyzing, summarizing information and trends while recommending actions.
• Provides technical leadership in achieving scientifically valid outcomes
• Ensures smooth and on time technology transfer to launch / commercial site.
• Jointly leads process validation activities.
• Effectively identifies critical process parameters with appropriate ranges to ensure robust, capable manufacturing procedures.
• Identifies and implements continuous improvement opportunities to eliminate waste and drive the business forward.
• Conducts incident investigations to determine root cause and assess product impact.
• Identifies corrective/preventative measures necessary for each observation made for improvement and aligns processes to consistently manufacture quality products.
• Provides documentation required at the completion of investigations; pulls all materials together into a concise summary that thoroughly documents the conclusions of the investigation.
• Collaborates with internal groups to determine and implement preventative measures to reduce/eliminate repetitive deviations. 3
• Provides technical support for implementation of manufacturing and packaging corrective and preventive actions
• Supports internal/external auditing or agency inspections
• Ensures on time manufacture and packaging of clinical supplies to fulfill clinical need
• Writes technical reports and presentation relevant to drug product continuous processing activities as well as prepares regulatory submission documents.