<div>More than one million people in the United States today are fighting blood cancer. While a traditional <a href="https://www.mayoclinic.org/tests-procedures/allogeneic-stem-cell-transplant/pyc-20384863">allogeneic stem cell transplant</a> 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 late-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.<b> </b><span>With our purified, high-precision investigational cell therapies we hope to not only replace patients blood and immune systems with healthy ones, but also restore their lives.</span></div><div><br /></div><div>We operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.</div><div><br /></div><div>The Manager, Operations and Logistics Support is a cross-functional role based at the Clinical Manufacturing facility, focused on enabling seamless collaboration across teams to support the production of life-saving therapies. This role works closely with Manufacturing, Quality, Facilities, Materials Management, MSAT, and IT to coordinate the efficient startup and execution of operational processes.</div><div><br /></div><div>The position is responsible for establishing and optimizing manufacturing workflows to ensure effective use of labor, smooth integration with analytical testing, and timely delivery of clinical products to patients. It also involves close collaboration with the logistics team to support the execution of patient batch orders, as well as the scheduling of routine non-patient operations, maintenance activities, and project work. In addition, the role supports capacity planning and production ramp-up initiatives to meet growing clinical demand at the clinical manufacturing facility.</div><h3>Physical Demands</h3><ul><li>Production Associates: 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.</li><li>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.</li></ul><h3>Work Conditions</h3><ul><li>Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.</li><li>Must be comfortable regularly participating in video-based meetings.</li><li>May be required to work scheduled overtime, weekends, or holidays based on business needs.</li></ul><h3>Essential Duties &amp; Key Responsibilities</h3><ul><li>Assess manufacturing processes in alignment with QC testing workflows to optimize execution from blood intake through patient delivery and product release</li><li>Develop SOPs and procedures to support efficient and compliant production processes</li><li>Collaborate with cross-functional teams to implement innovative solutions in accordance with GMP and regulatory requirements</li><li>Support logistics management for the delivery of starting materials from donors and drug product shipments to customers</li><li>Ensure documentation and preparations are in place for blood and graft pickups and deliveries</li><li>Oversee timely completion of post-run closeout documentation, including upload of data files, temperature reports, and Bill of Materials, for QA review</li><li>Execute cold storage practices and cryopreservation of drug products as needed</li><li>Assist QA in tracking and reporting metrics such as cycle times and production efficiency</li><li>Schedule and send logistics-related calendar invites (e.g., Credo conditioning, sample drop-offs, and sample requests) to relevant teams</li><li>Contribute to special projects focused on innovation and development of upcoming Orca products</li><li>Update and implement SOPs and batch records as needed to reflect process improvements and operational changes </li></ul><h3>Minimum Qualifications</h3><ul><li>Bachelor’s degree in life sciences, engineering, supply chain, operations management, or a related field</li><li>Minimum of 3 years of experience in a GMP-regulated clinical manufacturing, logistics, or operations environment</li><li>Working knowledge of GMP regulations, clinical production workflows, and compliance expectations</li><li>Proven ability to work cross-functionally with Manufacturing, Quality, Logistics, and other technical functions</li><li>Experience with logistics coordination, including managing patient- and donor-specific schedules and deliveries</li><li>Strong organizational skills with attention to detail and ability to handle multiple time-sensitive activities</li><li>Proficiency with Microsoft Office Suite and experience using digital systems (e.g., document control, scheduling tools)</li></ul><h3>Preferred Qualifications</h3><ul><li>Experience with cold chain logistics and cryopreservation of clinical drug products</li><li>Familiarity with ERP systems, LIMS, or other enterprise digital tools used in manufacturing and logistics</li><li>Prior involvement in SOP development, batch record review, and QA documentation closeout</li><li>Experience supporting capacity planning or clinical production scale-up</li><li>Demonstrated ability to contribute to process innovation or new product operations planning</li><li>Strong understanding of clinical supply chain management and quality metrics (e.g., cycle time)</li></ul><div>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. You will also be eligible to receive pre-IPO equity, in addition to competitive medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations.</div><div><br /></div><div><b>Who we are</b></div><div><br /></div><div>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.</div><div><br /></div><div>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.</div><div><br /></div><div>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.</div><div><br /></div><div>We maintain a start-up culture of camaraderie and leadership by example, regardless of title.</div><div><br /></div><div>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.</div><div><br /></div><div><b>Notice to staffing firms</b></div><div><br /></div><div>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.</div>