Sr. Manager, Site Technical Services Location: United States - Washington – Bothell Time Type: Vollzeit Posted On: Vor 5 Tagen Job Requisition ID: 4911486 Why Patients Need You Provide technical expertise in all areas in support of the site goals of being a clinical and commercial site for recombinant proteins and antibody drug conjugates products and a technical leader in the area of biologics manufacture. Lead troubleshooting efforts directed at technically complex issues that arise in manufacturing processes. Lead complex projects to address issues and develop and implement new technologies. As a member of the site senior leadership team, participate in developing short- and long-term strategies for the site. Lead efforts in technology transfer, validation, informatics, and process monitoring. Direct the efforts of assigned staff in compliance with all regulatory requirements, cGMPs, and company policies, procedures, and goals. What You Will Achieve Assures the appropriate interaction of all required groups, including Quality, Operations, Engineering & Maintenance, Materials Management, and Regulatory Affairs. How You Will Achieve It The Site Technical Services group is responsible for the following: Tech transfer of processes into and out of the North Creek. Site validation of equipment and systems, as well as process validation of new processes and process changes. Oversight of the informatics program including multivariate analysis, process monitoring, continuous process validation, and database management in partnership with IT groups. Providing technical support and leadership on highly technical, complex process issues. Evaluation and introduction of new and PAT enabling technology. The Site Technical Services Director (STSD) participates as a fully active member of the Pfizer Global Supply (PGS) North Creek site leadership team. The STSD has responsibilities for delivering on the site strategy via sponsorship and leadership of both functional and cross-functional projects and is expected to be an active participant on all cross-site teams. Other responsibilities include: Manages and leads all aspects of Site Technical Services and is accountable for setting the strategic direction for the function and ensuring its alignment with both the site and the network. Has accountability to lead the budget and resource planning process for the function. Develops ways of working that will support and contribute to the site safety efforts and meet all required environmental and industrial hygiene requirements. Sets the objectives for his/her leadership team. Advances the function's use of Right First Time/Six Sigma/Innovation problem-solving methodologies and leads efforts to advance Operational Excellence tools and innovative solutions. Acts as the site point of contact with external stakeholders, providing technical/site and leadership input into these site teams. Provides a platform of open communication within the function and the site, and also between the site and the network/business. Actively develops relationships within Pfizer and establishes relationships outside of Pfizer that will be beneficial to the site and PGS performance. Supports and actively collaborates with Quality, Manufacturing, and Regulatory to meet the increasing expectations of Board of Health inspections, and when necessary, supports regulatory submission. Has responsibility for Site Technical Services talent planning and development that includes coaching and mentoring, development, and performance management. Embraces and demonstrates leadership in our cultural journey, has change management abilities, and brings innovative ideas to increase awareness, participation, and engagement.
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