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.
We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Project Manager is responsible for managing defined cross-functional projects within the Project Management Office (PMO), with an emphasis on CMC implementation, Technical Operations, Manufacturing, Quality, Supply Chain, and Clinical or Development-related initiatives. This is a hands-on project management role with ownership of project plans, timelines, deliverables, risks, and cross-functional execution. The successful candidate will have direct experience driving projects in a biotechnology or pharmaceutical environment and will be comfortable working at the level of detail required to move complex, regulated work from plan through implementation. This individual must be able to translate project objectives, progress, risks, and decisions into clear project plans and concise communications for functional leaders and executives.
Physical Demands
Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
Work Conditions
Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.
Key Responsibilities:
Own and actively manage detailed cross-functional project plans from initiation through implementation, including scope, milestones, dependencies, deliverables, decision points, and critical path activities.
Manage defined CMC, Technical Operations, Manufacturing, Quality, Supply Chain, Clinical, and other business or operational projects, coordinating work across functional teams and maintaining accountability to agreed timelines and deliverables.
Build, maintain, and drive project schedules in Smartsheet; ensure plans accurately reflect current status, dependencies, risks, and changes in execution.
Identify schedule risks, resource or dependency constraints, and emerging blockers; work directly with project teams and functional leaders to develop mitigation plans, facilitate decisions, and escalate issues when appropriate.
Lead project meetings and working sessions, establish clear agendas and objectives, document key decisions and actions, and ensure appropriate follow-through across the project team.
Develop clear project status reports, RAID logs, dashboards, milestone views, and executive-level presentations that translate detailed project information into concise, decision-oriented communications.
Partner with Manufacturing, Quality, Technical Operations, Regulatory, Clinical, and Supply Chain stakeholders to support implementation activities in a regulated environment, including change controls, validation activities, operational readiness, and other project-specific deliverables.
Support PMO governance and portfolio management by providing accurate project data, communicating project health and priorities, and contributing to consistent project management practices across the organization.
Experience:
- Bachelor’s degree in Business, Engineering, Life Sciences, Biotechnology, or a related discipline, or equivalent relevant experience.
- Minimum of 3 years of hands-on project management or closely related experience in the pharmaceutical, biotechnology, cell therapy, clinical, medical device, or other regulated life sciences industry. Candidates with fewer years may be considered when their experience demonstrates meaningful ownership of complex cross-functional projects.
- Demonstrated experience directly managing CMC implementation, Technical Operations, pharmaceutical or cell therapy manufacturing, Quality, clinical operations, or comparable cross-functional life sciences projects. Experience must include active ownership of project execution, not solely meeting coordination or administrative support.
- Demonstrated experience building and actively managing detailed project plans using Smartsheet, Microsoft Project, OnePlan, or a comparable scheduling tool. Smartsheet experience is strongly preferred.
- Working knowledge of FDA-regulated environments and the project implications of GMP, GDP, quality systems, validation, change control, and operational or clinical implementation activities.
- Proven ability to manage multiple concurrent projects, dependencies, risks, and cross-functional stakeholders in a fast-paced environment with changing priorities.
- Strong written and verbal communication skills, including the ability to synthesize complex project information into concise status updates, dashboards, and executive presentations.
- Proficiency with Microsoft Office Suite, particularly PowerPoint and Excel. PMP or other recognized project management certification is preferred but not required.
