More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
The Project Coordinator supports the Project Management Office (PMO) by coordinating project schedules, maintaining project plans, tracking deliverables, and facilitating cross-functional communication across Technical Operations, Manufacturing, Quality, Regulatory, Clinical, and Supply Chain organizations. This role is responsible for maintaining accurate project data in Smartsheet, supporting governance meetings, producing project metrics and dashboards, and ensuring projects remain aligned with business priorities. The ideal candidate has prior pharmaceutical or biotechnology manufacturing experience and is highly proficient in Smartsheet.
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.
Skills:
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.
