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 Senior Specialist, Global QMS will help implement Orca Bio’s global quality management system across all sites. This role will support and lead the internal audit program, supplier management program, and inspection readiness. This role will support the growth and expansion of the global quality program to support manufacturing of our cell therapy products. You will help establish, implement and maintain the audit program across Orca Bio sites to ensure compliance with GxP and regulatory expectations. Your role will support Orca Bios commercial readiness and ongoing clinical programs by managing and facilitating audits, resolving supplier-related quality issues and interacting with quality management teams at the site levels to ensure consistent application of quality systems across the organization.
Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
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.
Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
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 Technician, Quality Assurance plays a critical role in supporting the production of Orca Bio’s life-saving cell therapy products by ensuring adherence to strict quality standards, cGMP compliance, and real-time production support. Reporting into the Quality Assurance leadership team, this position provides on-the-floor QA oversight, conducts real-time record and documentation review, and partners with manufacturing and technical teams to identify and resolve issues. The role collaborates closely with Manufacturing, Quality Control (QC), and other Quality functions to maintain seamless operations in a highly regulated environment.
Day Shift Hours Worked:
• 6:00am to 6:30pm or
• 6:30am to 7:00pm
Work Week Schedule:
• Sunday, Monday, Tuesday + every other Wednesday or
• Thursday, Friday, Saturday + every other Wednesday
Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
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.
Position Summary: The Senior Manager / Associate Director, Gross-to-Net (GTN) & Revenue Planning will own gross-to-net, revenue forecasting, and commercial operating expense forecasting for Orca Bio's first commercial product. Reporting to the Senior Director/Head, FP&A, this role establishes the accrual methodology, forecast architecture, documentation, and monthly cadence that a newly commercial company requires — in a product setting where individual transactions are material and where there is limited precedent to inherit. The position requires strong technical judgment, cross-functional partnership, and deep expertise in pharmaceutical revenue deductions and government pricing.
This is a hands-on individual contributor role. The successful candidate will build the models, run the monthly process, reconcile the underlying data, and present results directly to executive leadership and external auditors.
Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
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.
Summary of Position:
Reporting jointly into the Associate Director, Commercial Operations & Strategy and the Head of Product Supply, the Analyst, Operations & Analytics supports the data, analytics, and operational infrastructure behind Orca Bio's launch of TREGZI — working cross-functionally with supply chain, logistics, technical operations, commercial, and new product planning teams. A central part of the role is Project Sonar, Orca Bio's organization-wide AI enablement work stream, where this individual will translate business needs from across functions into working AI solutions.
Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
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.
Position Summary:
As Head of Business Development (reporting into CFO/Head of Strategy), you will drive the company's strategic partnership and licensing strategy, serving as the lead external interface for business development initiatives that advance Orca Bio's pipeline and commercial objectives. You will identify, evaluate, and negotiate partnerships with industry leaders, academic institutions, and research organizations to access promising therapeutics, expand our pipeline, and create strategic value.
This role combines deal leadership with strategic business planning, requiring both hands-on deal execution and high-level strategic thinking aligned with the board and executive leadership. You will work with an entrepreneurial spirit, while maintaining close collaboration with Scientific, Clinical, Regulatory, Manufacturing, and Commercial teams to ensure partnerships align with scientific merit, regulatory strategy, and business objectives.
You will be responsible for overseeing the full portfolio of potential strategic partnerships, from sourcing and evaluation through negotiation, execution, and ongoing relationship management, serving as a strategic advisor to the C-suite on market opportunities, partnership trends, and business development strategy.
Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
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.
Position Summary:
The Manager, Manufacturing Systems & Master Data serves as the business owner and super user for the company's Manufacturing Execution System (MES) and related manufacturing and supply chain applications. This role is responsible for governing manufacturing master data, driving system improvements, optimizing business processes, and ensuring system capabilities effectively support GMP manufacturing, inventory management, procurement, quality, planning, and commercial operations.
The Manager owns the creation and maintenance of manufacturing and supply chain master data, including material masters, inventory masters, Bills of Materials (BOMs), product specifications, packaging configurations, vendor master records, release testing requirements, and manufacturing data.
In addition, this role leads continuous improvement initiatives for ERP/MES functionality, serves as the primary business liaison to Information Technology, Finance and Software vendors, and ensures business systems evolve to meet operational and regulatory needs. No direct reports.
Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
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 Operations Supervisor, Logistics & Cold Chain Operations leads the teams responsible for the secure, compliant, and on-time movement of donor cells and cell therapy drug products between Orca Bio's Sacramento manufacturing sites and transplant centers nationwide. This is a hands-on people- leadership role that owns end-to-end operational readiness across two functions: the Logistics Specialist team, which coordinates live courier runs, disruption response, chain-of-custody, and vein-to- vein (V2V) performance; and the cold chain / packaging operations hourly team, which prepares, charges, and qualifies shippers and executes GMP packing and handover.
This is a hands-on leadership role. Reporting to the Logistics Program Manager, the Operations Supervisor owns full operational accountability for their team — staffing and qualification currency, KPI performance, real-time disruption response, and continuous improvement — and is expected to be present and available for their team through the parts of the day that matter most. Each Operations Supervisor partners closely with their day-side/night-side counterpart to ensure consistent leadership and a clean handoff between teams. The ideal candidate is a calm, decisive operator who builds strong teams, thrives in a fast-paced regulated environment, and can move fluidly between strategic planning and real-time problem-solving when a shipment is at risk.
Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
Engineering
29 days ago
Senior Engineer, Process Validation - Cell Therapy
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.
Orca Bio is seeking a highly skilled Senior Process Validation Engineer to join our Validation group in Sacramento, CA. In this role, you will hold primary ownership over the Process Validation lifecycle—including overall Process Validation Master Plans (PVMP), Process Performance Qualification (PPQ), Aseptic Process Simulations (APS), and Shipping Validation.
You will work closely with Manufacturing (MFG), MSAT, CMC, Quality Assurance, and Supply Chain to establish, verify, and maintain the validated state across our cell therapy drug product processing and shipping channels.
Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.
Medical Science Liaison - Southeast
RemoteMedical Affairs – Medical Affairs /Regular, Full-Time Employee /Remote
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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.
Position Summary:
The MSL reports to the Sr. Director, National Field Medical Affairs and will be responsible for fostering strong relationships with key opinion leaders (KOLs) and supporting the scientific and clinical strategy of Orca Bio's next generation allogeneic cell therapies. The ideal candidate will possess deep expertise in hematopoietic stem cell transplantation (HSCT), cellular therapy, and the evolving cell therapy landscape, including clinical, operational, regulatory and market access considerations. The MSL will serve as trusted scientific partner between Orca Bio and external healthcare providers (HCPs) establishing strong professional collaborations with investigators and other HCPs within the designated territory. Additionally, you will serve as an active leader and contributor on projects in support of the Medical Affairs Strategic Objectives.
Candidate must reside in Florida, South Carolina, Georgia, Alabama, Mississippi, Louisiana, or Arkansas.
Responsibilities
Serve as a subject matter expert in stem cell transplantation, cell therapy, and the evolving cellular immunotherapy landscape, providing scientific insights regarding current treatment paradigms, clinical operations, patient access and emerging competitive landscape
Identify, develop, and maintain deep scientific, peer-to-peer relationships with academic stem cell therapy experts as well as thought leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific and product related questions, to ensure their safe and appropriate use of Orca Bio products through peer-to-peer discussions aligned with medical strategies and needs expressed by external stakeholders
Prepare and maintain a territory management plan that will be shared with Medical Leadership and other internal stakeholders
Engage with Orca “Pod” field team members to provide appropriate medical support for all onboarding activities in relation to authorizing treatment centers, adverse event reporting, handling out of spec products, as well as partnering with regional Market Access colleagues to provide medical education and support to local payers in alignment with Market Access tactical plan and individual patient needs
Develop and maintain a deep and current understanding of hematologic malignancies, stem cell transplantation, cell therapy, cellular immunotherapy and competitive developments to facilitate high level scientific exchange with health care professional and key opinion leaders
Actively assess the transplant and cell therapy landscape through ongoing engagement with key opinion leaders, investigators, and academic research centers to identify emerging scientific trends, evidence gaps, and novel research opportunities relevant to Orca Bio's therapies. Serve as the primary liaison for Orca Bio's Investigator-Sponsored Trial (IST) program, partnering with investigators to develop and refine research concepts, evaluate scientific merit and strategic alignment, support proposal and protocol development, present qualified concepts to review committees, communicate governance decisions, and provide scientific oversight throughout study start-up, conduct, publication planning, and dissemination of results
Gather and communicate actionable scientific insights and stakeholder feedback to Orca Bio leadership and cross-functional partners to inform medical strategy, evidence generation priorities, and lifecycle planning
Provide scientific and clinical expertise to support internal and external stakeholders, through participation in advisory board meetings, clinical investigator meetings, roundtable discussions, educational meetings, interactions with professional organizations/societies, advocacy groups, GPOs, and large networked practices as needed, including speaker bureaus
Support clinical trial activities to enhance patient recruitment, enrollment and/or discussions around the safe and effective use of Orca Bio investigational products, leveraging clinical trial experience and knowledge of Good Clinical Practice (GCP) to ensure adherence to ethical and regulatory standards
Lead the collection, analysis, synthesis and dissemination of scientific information presented at congresses and during scientific exchange. Translate emerging clinical trial data, competitive intelligence and external stakeholder feedback into actional recommendations for Orca Bio leadership and cross functional teams. When assigned, coordinate the efforts of other MSLs to provide coverage for a specific congress to maximize organizational impact
Provide medical and scientific support of the strategy of health outcomes, real-world evidence, and payer/provider engagements
Initiate and autonomously execute projects that align with Orca Bio’s scientific, clinical and business operations partnering with research, clinical development, commercial, market access, regulatory, and quality functions to drive company strategy
Provide education and training to commercial marketing and sales teams on therapies and disease states
Required Qualifications
Advanced clinical degree in a life-science or basic-science discipline (MD, DO, PharmD, NP, PA, DNP, M.Sc, or Ph.D.) and industry experience as an MSL
Significant clinical and/or industry experience in malignant hematology, hematopoietic stem cell transplant (HSCT), cellular therapy, CAR-T, immune effector cell therapies, and/or other advanced therapy modalities
Strong understanding of cell therapy ecosystem, including transplant center operations, apheresis and cell processing workflows, treatment center authorization, patient referral pathways and competitive cell therapy products
Strong understanding of clinical development, regulatory requirements, and commercial strategies; experience with HEOR data is a plus
Excellent interpersonal and communication skills, with the ability to engage and influence a wide range of stakeholders
Demonstrated ability to interpret and present complex scientific data to diverse audiences
Strong strategic thinking, problem-solving skills, and solution-oriented mindset
Demonstrated ability to collaborate with cross-functional colleagues to best serve the needs of internal and external stakeholders
Ability to work independently and manage multiple priorities in a fast-paced, dynamic environment
Preferred Experience
5+ years of industry experience as an MSL
Demonstrated experience with field medical launch planning, execution, and post-launch support
Direct experience supporting cell therapy, stem cell transplantation, CAR-T or other advanced therapeutic platforms
Experience working in a small biotech company or start-up environment
$195,000 - $245,000 a year
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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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