Project Coordinator - Project Management Office (PMO)
Summary
Coordinates biotech manufacturing projects using Smartsheet, tracking milestones and GMP compliance across Quality, Manufacturing, and Clinical teams.
Key Responsibilities:
- Maintain and administer complex Smartsheet project plans, dashboards, reports, automations, and resource views for multiple cross-functional programs.
- Coordinate project activities across Manufacturing, Quality, Regulatory, Clinical Operations, Technical Operations, Supply Chain, and other functional teams to ensure project milestones and deliverables remain on track.
- Prepare project documentation including meeting agendas, minutes, action items, RAID logs, project schedules, status reports, and executive dashboards.
- Monitor project timelines, identify schedule risks, follow up on overdue action items, and escalate issues to Project Managers when appropriate.
- Support PMO governance processes by organizing portfolio review meetings, updating project metrics, and maintaining project documentation in accordance with company procedures.
- Collaborate with Quality and Manufacturing teams to ensure project documentation supports GMP requirements, document control processes, change controls, validation activities, and inspection readiness.
- Generate reports and metrics from Smartsheet to support executive decision-making and portfolio management.
- Support continuous improvement initiatives by recommending enhancements to PMO processes, Smartsheet solutions, and project reporting.
Qualifications:
Education:
- Bachelor’s degree in Business, Engineering, Life Sciences, Biotechnology, or a related discipline (or equivalent experience).
Experience:
- Minimum 1-4 years of project coordination, project management support, or project operations experience within biotechnology, pharmaceutical, cell therapy, medical device, clinical, manufacturing, or other regulated industries.
- Required experience supporting pharmaceutical manufacturing, GMP operations, Technical Operations, or Quality organizations.
- Demonstrated proficiency in Smartsheet, including formulas, dashboards, reports, workflows/automation, forms, cross-sheet references, and resource management.
- Strong understanding of FDA-regulated environments, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and quality systems.
- Experience supporting cross-functional teams and managing multiple concurrent projects in a fast-paced environment.
- Excellent organizational, written communication, and stakeholder management skills.
- Experience with Microsoft Office Suite (Excel, PowerPoint, Word); familiarity with Microsoft Project, SharePoint is preferred.
As published by lever
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