Director Site Technical Services

Pfizer • Kalamazoo, MI

22h • Onsite

About The Position

Provide leadership, strategic direction and technical oversight of Site Technical Services in support of the site’s manufacturing, process development, and technical operations. Be an active member of the Site Leadership Team. Attract, retain and grow technical talent. Set strategy and direction for technical aspects of site operations. Connect to the PGS network in support of technology implementation, product development, knowledge transfer and technical issue resolution. Be externally connected to bring contemporary and innovative solutions to PGS sites. The primary function of the Director, Site Technical Services is development and application of advanced manufacturing, science and technology processes by monitoring process performance against expectations to ensure product quality. This individual will partner with manufacturing and process development, ensuring the successful execution of quality lots with respect to process performance and product quality. This role manages the site’s Product and Process Technology (PPT) and Drug Product Manufacturing Technology (DPMT) teams. The Director, Site Technical Services will explore potential process improvements; as well as, lead and participate in start-up efforts of new equipment, software or processes in manufacturing. This person will establish small-scale production processes and using scaled-down lab processes to enable process troubleshooting and implement changes to procedures and creating documentation for changes to manufacturing processes. This person will manage project activities through provision of oversight and guidance. Primary accountabilities include: In partnership with Quality, routinely monitor all Site Validation practices and procedures to ensure compliance with current cGMP regulations, Pfizer Global SOPs and industry guidance. Maintain robust validation systems that consistently produce high quality product. Ensure validation systems are applied and operated across all site GMP operations. Develop qualified and capable validation talent and assure appropriate talent is in place to meet current and future business needs. Implement best in class validation approaches at site and provide technical expertise to all functions. Lead the conversation with regulators to present and defend validation systems and industry expectations. Review and approve SOPs dealing with validation processes. Leadership/managerial responsibilities for direct reports: examples include, provide leadership to subordinates by managing, mentoring, coaching and developing them towards professional and personal growth, enhanced job performance and career satisfaction. Manage departmental budget. Participate in or lead complex investigations for validation or quality related issues. Leadership and development of the key scientific and technical resource supporting manufacturing processes for Kalamazoo products. Maintain high standards for the technical work delivered by the department. Increase the breadth and depth of skill base in alignment with the site strategic direction. Support IMEX processes and tiered governance, enabling Technical Services colleagues to deliver continuous improvement and operational performance. Support and foster Supportive Leadership among people leaders within Technical through active coaching. Provide technical support for equipment and process validation activities, process overview training to support implementation of new process technologies, and process specifications to support defining the scope of capital projects. Develop lists of potential process improvements; develop data packages by justifying and outlining recommendations for changes to or improvements in production processes, collaborating with technical staff to ensure consistency with corporate process technology initiatives. Provide change management and implementation for changes to the manufacturing processes and associated systems and provide training for technical staff on major changes to processes, equipment and documentation.

Requirements

• Bachelor's degree with at least 8 years of experience; OR a master's degree with at least 7 years of experience; OR a PhD with 5+ years of experience
• Previous supervisory/management experience
• Demonstrated ability to actively participate in the resolution of technical challenges and technical advances.
• Demonstrated problem solving, decision making, negotiating and conflict resolution skills.
• Demonstrated skills in quantitative analysis, team facilitation and effective communications (both oral and written).
• In-depth understanding of GMP and regulatory standards.
• Demonstrated ability to effectively lead and manage change.
• Proven history of effective performance management, coaching, mentoring and commitment to mutual accountability.
• 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 of other colleagues to achieve meaningful outcomes and create business impact.
• Permanent work authorization in the United States.

Responsibilities

• Provide leadership, strategic direction and technical oversight of Site Technical Services in support of the site’s manufacturing, process development, and technical operations.
• Be an active member of the Site Leadership Team.
• Attract, retain and grow technical talent.
• Set strategy and direction for technical aspects of site operations.
• Connect to the PGS network in support of technology implementation, product development, knowledge transfer and technical issue resolution.
• Be externally connected to bring contemporary and innovative solutions to PGS sites.
• Develop and apply advanced manufacturing, science and technology processes by monitoring process performance against expectations to ensure product quality.
• Partner with manufacturing and process development, ensuring the successful execution of quality lots with respect to process performance and product quality.
• Manage the site’s Product and Process Technology (PPT) and Drug Product Manufacturing Technology (DPMT) teams.
• Explore potential process improvements.
• Lead and participate in start-up efforts of new equipment, software or processes in manufacturing.
• Establish small-scale production processes and using scaled-down lab processes to enable process troubleshooting and implement changes to procedures and creating documentation for changes to manufacturing processes.
• Manage project activities through provision of oversight and guidance.
• Routinely monitor all Site Validation practices and procedures to ensure compliance with current cGMP regulations, Pfizer Global SOPs and industry guidance.
• Maintain robust validation systems that consistently produce high quality product.
• Ensure validation systems are applied and operated across all site GMP operations.
• Develop qualified and capable validation talent and assure appropriate talent is in place to meet current and future business needs.
• Implement best in class validation approaches at site and provide technical expertise to all functions.
• Lead the conversation with regulators to present and defend validation systems and industry expectations.
• Review and approve SOPs dealing with validation processes.
• Provide leadership to subordinates by managing, mentoring, coaching and developing them towards professional and personal growth, enhanced job performance and career satisfaction.
• Manage departmental budget.
• Participate in or lead complex investigations for validation or quality related issues.
• Lead and develop the key scientific and technical resource supporting manufacturing processes for Kalamazoo products.
• Maintain high standards for the technical work delivered by the department.
• Increase the breadth and depth of skill base in alignment with the site strategic direction.
• Support IMEX processes and tiered governance, enabling Technical Services colleagues to deliver continuous improvement and operational performance.
• Support and foster Supportive Leadership among people leaders within Technical through active coaching.
• Provide technical support for equipment and process validation activities, process overview training to support implementation of new process technologies, and process specifications to support defining the scope of capital projects.
• Develop lists of potential process improvements.
• Develop data packages by justifying and outlining recommendations for changes to or improvements in production processes, collaborating with technical staff to ensure consistency with corporate process technology initiatives.
• Provide change management and implementation for changes to the manufacturing processes and associated systems.
• Provide training for technical staff on major changes to processes, equipment and documentation.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Additional Pfizer Retirement Savings Contribution
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage.
• Relocation support available
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Director