Technical expert that will independently investigate, identify, develop and optimize new methods/ techniques to address critical project needs. Continuously seek to improve existing laboratory methods and processes. Read and adapt literature to accomplish assignments. Demonstrate mastery of broad range of experimental techniques and methods of data analysis.

Responsibilities

• Lead projects impacting manufacturing to achieve process efficiencies, such as, increase in process yield, quality improvements, cycle time/throughput, and cost reduction initiatives.
• Gather and analyze process data using statistical process control methodology for the purpose of monitoring process performance. Develop action plan to increase process robustness, prevent product loss, and control quality impact.
• Responsible for providing technical support in the resolution of manufacturing investigations and executing assigned tasks as required, such as, laboratory experiments.
• Lead investigations by following a structure problem solving approach and employing sound, scientific principles when identifying root cause and developing recommendations related to product and process. Generate technical justification to support and/or document process deviations/investigations and determine impact in product quality, yield, and product registration.
• Member of a cross-functional team responsible for implementation of site projects/initiatives (continuous improvement, cost reduction, capacity increase, etc.) that lead to process remediation.
• Project management of smaller team sub-projects in support of larger projects. Responsibility may include project coordination, monitoring, reporting, meeting management, and team communication.
• Lead the implementation of process validation for technology transfers, 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 and process documentation and assure they are in compliance with applicable procedures and regulations. Writes justification memos and scientific reports supporting quality controls and manufacturing documents.
• Provide scientific and technical support during regulatory audits, agency inspections and regulatory submissions (IND, BLA, NDA, PAS, etc)
• Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of Abbvie's EHS program.

Preferred Qualifications:

• Technical knowledge in fundamentals of pharmaceutical process (sterile/aseptic product manufacturing, media fill, sterilization, fill finish operations, cGMP).
• Experience with process validation and technology transfers
• Fundamental knowledge of Medical Device Design Control (DHF, EU MDR, CE Mark)
• Strong data analysis skills and experience (Minitab, JMP, Lean Six Sigma)
• Demonstrated ability to independently design, execute and interpret critical experiments to answer scientific questions.
• Demonstrated ability to learn, understand and master new experimental techniques.
• Ability to multitask and work within timelines (Project management).