Senior Manager, Project Management, Cell Therapy Manufacturing

About the role

This position is responsible for leading the planning and managing the execution of major cross-functional projects, project workstreams, and programs for the manufacturing site. The project manager role contributes to the success of the site by partnering with leads and sponsors to apply an organized approach to project initiation, planning, and execution, driving the delivery of complex changes.

Responsibilities

• Develop and execute the planning approach for large, complex, and high visibility projects and programs including project structure, governance structure, planning activities, and planning schedule.
• Identify stakeholders and drive conversations to align on clear project requirements, scope, and deliverables.
• Leverage site and global resources to identify the activities needed to produce the deliverables.
• Identify and secure internal and external resources required to execute the work.
• Support the capital asset request and budget management process where applicable.
• Develop and manage detailed project schedules.
• Drive and track execution of project activities to ensure deliverables are completed on time and in alignment with Quality standards.
• Plan and manage project team workshops and meetings.
• Communicate outcomes via meeting notes, risk and issue logs, and action items logs in alignment with site practices.
• Actively lead the identification, assessment, and management of project risks including development of mitigation and contingency plans to minimize project impact.
• Drive the escalation and resolution of project issues including leadership communication and collaboration.
• Ensure appropriate documentation of risks and issues for business continuity and continuous improvement.
• Control changes to scope and timeline in conjunction with project sponsors and governing bodies.
• Prepare and deliver presentations and project status updates to project team members, leaders, and other stakeholders to ensure ongoing visibility to project plans, status, decisions, risks, and issues.
• Effectively capture and share project information with stakeholders including use of online knowledge management tools.
• Lead planning and management of cutovers to ensure regulatory and cGMP compliance.
• Lead and manage operational handoff and project closure activities in line with site best practices.
• Promote excellence in project management capabilities through use of PMO best practices, knowledge sharing, innovation, and process improvements.
• Identify and champion opportunities for more efficient or effective planning and execution of future projects.

Requirements

Bachelor’s degree in engineering, science, information technology, business, or related field. 8 years of relevant business experience including at least 2 years of demonstrated experience directly managing projects. Preferred 3 years of experience in a biopharma or health science discipline. Strong knowledge of financial, operational, and business management principles. Experience working in cell therapy, Good Manufacturing Practices, FDA regulated, or other regulated environments is preferred. Highly proficient in Microsoft Outlook, Teams, Project, Excel, and PowerPoint. Proficient OneNote and SharePoint user. SharePoint page development and Smartsheet skills helpful. High level of knowledge and competency applying predictive/waterfall, iterative, and hybrid project management processes and methodologies. PMP certification highly desirable. Experience driving large complex projects and programs forward with minimal direction and a high level of accountability from initiation to closure. Exceptional organizational and time management skills. Can efficiently manage and communicate a high volume of information across a diverse set of stakeholders. Effective verbal, written and presentation skills. Skilled in navigating across a global matrix organization and influencing others to achieve results. Analytical problem solving and critical thinking skills. Understands detailed relationships and can quickly assess the impact of new information. Comfortable working in a rapidly changing environment. Able to manage multiple projects or workstreams simultaneously and prioritize across competing demands. A passion for learning and improvement with demonstrated actions to advance project management proficiency. A team player who is skilled at building positive relationships and drives a collaborative project team and PMO work environment. Experience working in project management consulting a plus.

Qualifications & Experience

• Bachelor’s degree in engineering, science, information technology, business, or related field.
• 8 years of relevant business experience including at least 2 years of demonstrated experience directly managing projects.
• Preferred 3 years of experience in a biopharma or health science discipline.
• Strong knowledge of financial, operational, and business management principles.
• Experience working in cell therapy, Good Manufacturing Practices, FDA regulated, or other regulated environments is preferred.
• Hightly proficient in Microsoft Outlook, Teams, Project, Excel, and PowerPoint.
• Proficient OneNote and SharePoint user.
• SharePoint page development and Smartsheet skills helpful.
• High level of knowledge and competency applying predictive/waterfall, iterative, and hybrid project management processes and methodologies.
• PMP certification highly desirable.
• Experience driving large complex projects and programs forward with minimal direction and a high level of accountability from initiation to closure.
• Exceptional organizational and time management skills.
• Can efficiently manage and communicate a high volume of information across a diverse set of stakeholders.
• Effective verbal, written and presentation skills.
• Skilled in navigating across a global matrix organization and influencing others to achieve results.
• Analytical problem solving and critical thinking skills.
• Understands detailed relationships and can quickly assess the impact of new information.
• Comfortable working in a rapidly changing environment.
• Able to manage multiple projects or workstreams simultaneously and prioritize across competing demands.
• A passion for learning and improvement with demonstrated actions to advance project management proficiency.
• A team player who is skilled at building positive relationships and drives a collaborative project team and PMO work environment.
• Experience working in project management consulting a plus.