PROCESS ANALYTICAL TECHNOLOGY LEADER

Talecris Biotherapeutics
Clayton

As one of the world’s foremost providers of premium protein therapies, Talecris Biotherapeutics not only saves lives, we also improve the quality of life for people around the globe. We have the expertise, resources and established business infrastructure to develop, manufacture and market biotechnology products internationally. Make a positive difference in the lives of others by joining us at our Clayton, NC manufacturing facility as a: PROCESS ANALYTICAL TECHNOLOGY LEADER

This individual will lead and coordinate the PAT (Process Analytical Technology) effort at Talecris. We focus on fostering a best in class environment for the development, manufacture and regulation of biological products through: -Availability and analysis of data -Process understanding and Critical Quality Attributes (CQAs), -Utilization of process capabilities (maximize yield and throughput within CQA) Our PAT implementation group provides engineering and scientific leadership in the areas of process improvements, data analysis and implementation of new process analytical applications. This position is heavily involved in Instrumentation, Controls and Process Automation related to manufacturing. The group provides data analysis, data management, statistical process control, and process system engineering technical expertise to support clinical and commercial manufacturing. The PAT leader will organize a multidisciplinary PAT Core Team on diverse projects and will act as an Engineering Services contact for R&D departments at Talecris. Additional responsibilities include the implementation of PAT efforts that evaluate the feasibility of online instruments to monitor key critical attributes, performance of proof of concept studies on new applications and identification of opportunities to optimize current processes. We want someone who will champion the PAT function to new areas, support business case development for PAT projects and lead their installation, qualification and integration into process controls. Will work with the PAT Core Team and management to continue to develop and define the PAT approach for the Talecris. Participates in identification, justification, development and implementation of PAT strategies and communicates the ideas to the PAT Core Team. You will also maintain established Talecris presence in the industry through conference participation and external networking.

Position requires a BS, MS or Ph.D, preferably in Chemical or Electrical Engineering and 4-6 years of engineering or technical experience in areas of analytical development, data analysis, risk management and analytical method validation. Candidate must have knowledge of troubleshooting methods, reliability approaches, and quality management/process improvement/re-engineering programs. Solid skills in accounting principles, root cause analysis, statistics, and project engineering tools is required, as is an understanding of P&ID’s, loop diagrams, field instrumentation and I/O devices. Expertise in multiple process control engineering is desired. Excellent communication, presentation and team building skills are essential. Must have professional registration and/or certifications. Talecris offers a competitive salary and benefits package, including 401(k) with company match, management and profit sharing bonus potential and a generous tuition reimbursement program. Please apply at: www.talecris.com to Position #2673. (No Agency Calls, Please) EOE M/F/D/V committed to enhancing and manufacturing cultural diversity within our work environment.

www.talecris.com