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.

The Candidate

B.S. in Chemistry, Pharmaceutical Technology, or Pharmacy with 8

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