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A senior level technical contributor providing project management, planning, execution, and guidance in the the development and optimization of manufacturing, packaging, and cleaning processes for new and existing drug product formulations, from benchtop through scale-up and commercialization. This includes the independent preparation and execution of experimental protocols, in-process sample analysis, coordination of analytical testing, data interprRégionion, and technical report preparation to summarize findings. This postiion is also responsible for the manufacturing and packaging of clinical supplies, and leads technology transfers between sites. The Sr. Pharmaceutical Scientist II in Technical Services plays a substantial role in leading cross-functional projects for the implementation of site strategic initatives.
In addition, the successful candidate will be responsible for technical input with regard to problem solving and process/product improvements in support of current commercial manufacturing, packaging, and cleaning operations. This requires that appropriate and timely investigations are conducted that identify root cause and appropriate preventative and corrective actions. This postion requires a thorough understanding of manufacturing equipment and processes as well as the formulation/equipment interactions.
• 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.
• B.S. in Chemistry, Pharmaceutical Technology, or Pharmacy with 8 – 12 years of experience in the pharmaceutical industry in the area of Engineering, Technical Services, Product/Process Development, or Validation Or M.S. with 5 - 8 years’ experience; Or Ph.D. with 3 - 5 years’ experience.
• Expertise with solid and liquid pharmaceutical manufacturing processes, equipment, and operations.
• Experience with current Good Manufacturing Practices (cGMP)
• Proven ability to work on complex problems and interpret scientific data where analysis requires an evaluation of intangible variables.
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