Sr. Manager, Site Technical Services

Why Patients Need You

Provide technical expertise in all areas in support of the site goals of being clinical and commercial site for recombinant proteins and antibody drug conjugates products and a technical leader in the area 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 member of the site senior leadership team participate in developing short- and long-term strategies for the site. Lead efforts in the area of technology transfer, validation, informatics and process monitoring   Lead effort in developing strategies around technologies and advanced manufacturing options.  Directs 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 group, including Quality, Operations, Engineering & Maintenance, Materials Management, 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 multi variant 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 will meet all required environmental and industrial hygiene requirements

• Sets the objectives for his/her leadership team.

• Advances the functions 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 establishing 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.

BASIC QUALIFICATIONS

•  BS in a scientific or engineering discipline required.

• 15+ years of pharmaceutical or cGMP manufacturing experience required.

• 10+ years of experience in the field of biological production process, cell culture, and protein purification required.

• 5+ years of direct management experience, including demonstrated experience leading technically complex projects and senior level scientist and engineers, required.

• Must have administrative, managerial skills, technical report writing, computer, and presentation skills.

• Working knowledge of the relevant portions of cGMP regulation is required.

• Demonstrated breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work