Role Summary
Manager, Project Management, Cell Therapy at the Devens, MA site leads cross-functional projects in manufacturing, including site readiness for new launches, implementation of new technologies and materials, information system updates and migrations, changes to plant capabilities, and technical and business process changes. Works with site and global stakeholders across manufacturing, quality, supply chain, information technology, facilities, manufacturing science & technology, and other functional areas to apply an organized approach to project planning and drive execution in a dynamic cell therapy environment. Reports through the site's PMO and contributes to maturation of site project and portfolio management processes, tools, and methodologies.
Responsibilities
- Lead project planning, including development of the approach, planning activities, and planning schedule.
- Identify stakeholders and drive conversations to align on clear project requirements, scope, and deliverables.
- Ensure project goals and benefit KPIs are clearly defined and aligned with site's strategic objectives; hold the team accountable to measure impact and value delivered.
- Leverage site and global resources to identify activities needed to produce deliverables.
- Plan and secure resources, maintain accurate resource allocations, and advise on constraints.
- Develop and maintain project budget and regular reporting (with finance and project engineering).
- Develop and manage detailed project schedules; coordinate and track execution to ensure deliverables are completed on time and in alignment with Quality standards.
- Lead development of integrated timelines, ensuring alignment with Global Project timelines; develop critical path analyses to identify risks and opportunities.
- Plan and manage project team workshops and meetings; communicate outcomes via notes, logs, and action items in line with site practices.
- Identify project and program risks; document and develop contingency plans with the team.
- Control changes to scope and timeline with sponsors and governance bodies.
- Prepare and deliver presentations and status updates to stakeholders to maintain visibility of plans, status, decisions, risks, and issues.
- Capture and share project information electronically using knowledge management tools.
- Lead planning and communications for cutovers to ensure regulatory and cGMP compliance.
- Conduct lessons learned and share with the organization to foster continuous improvement.
- Coach organization on project and portfolio management processes.
- Ensure recommendations needing governance endorsement are reviewed at appropriate milestones; use lean tools as appropriate; maintain alignment and standardization of PMO practices.
- Promote excellence in project management by leveraging PMO best practices, knowledge sharing, and cross-functional collaboration.
Qualifications
- Bachelor's degree in engineering, science, information technology, business, or related field
- 5 years of relevant work experience including 2 years of project experience, preferably in life sciences
Skills
- Experience in biopharma, cell therapy, GMP, or FDA-regulated environments is a plus
- Experience with predictive/waterfall project management processes and methodologies; PMP/CAPM certification a plus
- Basic knowledge of financial, operational, and business management principles
- Proficient in Microsoft Outlook, Teams, Project, Excel, SharePoint, PowerPoint, and Visio
- Experience with OnePlan Portfolio Management a plus
- Ability to take initiative and work independently with a high level of accountability
- Exceptional organizational and time management skills; ability to manage a high volume of information
- Effective verbal, written, and presentation skills; able to navigate a global matrix and influence others
- Analytical problem solving and critical thinking; understands detailed relationships and assesses impact of new information
- Comfortable in a rapidly changing environment; ability to prioritize across competing demands
- Desire to learn and improve project management proficiency; team-oriented and collaborative
- Ability to enter laboratory/manufacturing spaces requiring PPE
- Ability to work in an office setting with routine computer use
- Up to 5% travel
Additional Requirements
- None beyond travel/physical requirements noted above