The Role
Supports the PMO by maintaining Smartsheet project plans, dashboards, schedules, reports, and project documentation. Coordinates cross-functional activities across manufacturing, quality, regulatory, clinical, technical operations, and supply chain teams. Tracks milestones, risks, deliverables, and action items; supports governance meetings; prepares metrics for executive decision-making; and helps ensure documentation aligns with GMP, quality systems, validation, change control, and inspection-readiness requirements.
Summary Generated by Built In
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:
- Bachelor’s degree in Business, Engineering, Life Sciences, Biotechnology, or a related discipline (or equivalent 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.
Education:
Experience:
Skills:
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
Skills Required
- Bachelor’s degree in Business, Engineering, Life Sciences, Biotechnology, or a related discipline, or equivalent experience
- 1–4 years of project coordination, project management support, or project operations experience in biotechnology, pharmaceutical, cell therapy, medical device, clinical, manufacturing, or another regulated industry
- Experience supporting pharmaceutical manufacturing, GMP operations, Technical Operations, or Quality organizations
- Proficiency in Smartsheet, including formulas, dashboards, reports, workflows or automation, forms, cross-sheet references, and resource management
- Understanding of FDA-regulated environments, Good Manufacturing Practices, Good Documentation Practices, and quality systems
- Experience supporting cross-functional teams and managing multiple concurrent projects
- Strong organizational, written communication, and stakeholder management skills
- Experience with Microsoft Office Suite, including Excel, PowerPoint, and Word
- Familiarity with Microsoft Project and SharePoint
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The Company
What We Do
Orca Bio is a clinical-stage biotechnology company developing a pipeline of high precision allogeneic cell therapy products that are designed to safely replace patients’ diseased blood and immune system with a healthy one. Our manufacturing platform sorts donor blood with single-cell precision and a high level of purity and speed, enabling us to create proprietary, optimal therapeutic mixtures of immune and stem cells that have the potential to transform allogeneic cell therapy. Our talented team is driven by a passion for science and compassion for patients.
