Scientist Ii - Pharmacy

Job Description
Technical expert with hand-on experiences with process validation, process technology transfers, sterile product support, aseptic process development and design control.
Experience with Sterile GMP, Project Management, IND and BLA submission, Six Sigma and in development and manufacturing of ophthalmic products will be highly considered.
Responsibilities:
Independently investigate, identify, develop and optimize new methods/process/techniques to address critical project needs.
Play a critical role as cross functional team member to achieve process efficiencies such as increase process yield, quality improvements, cycle time/throughput, and cost reduction initiatives.
Gather and analyze process data using statistical process control methodology. Develop action plan to increase process robustness, prevent product loss, and control quality impact. Participate in process performance monitoring such as Track &
Trend.
Responsible for providing technical support in the resolution of shop floor situations and executing assigned tasks as required by the operational area.
Generate technical justification to support and/or document process deviations/investigations and determine impact in product quality, yield, and product registration.
Play a critical role as cross functional team member to implement operational changes, new raw materials, and introduction of new process/technology. Generate technical justification determining impact of change and protocols/reports/manufacturing documents that support its execution. Assist the execution of experimental, demonstration, and validation lots.
Maintain up-to-date product process documentation and assure they are in compliance with applicable procedures and regulations. Writes justification memos and scientific reports of quality controls and manufacturing documents.
Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of AbbVie's EHS program.
Independently design, execute and interpret critical experiments to answer scientific questions. Understand the broad objectives of the project as well as their role in achieving those objectives, and modify experimental plan when required, to respond.
Effectively organize and present scientific plans and data.
Contribute to writing and conceptual framework of publications, presentations, and patents.
Routinely read and apply relevant scientific literature. Impact projects mostly through lab and/or pilot-plant based activities where applicable.