Sacramento, California, United States · On-site
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 ser…
Skills: Process Validation, Cell Therapy, Quality Assurance
Menlo Park, California, United States · On-site
$100k–$120k/yr
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 ser…
Skills: Accounts payable, General ledger, Monthly close, Accruals, Statutory compliance
Remote OK
$195k–$245k/yr
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 ser…
Skills: Hematopoietic stem cell transplantation, Cellular therapy, Immunotherapy, Medical science liaison, Clinical development
Remote OK
$195k–$245k/yr
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 ser…
Skills: Hematopoietic stem cell transplantation, Cellular therapy, Immunotherapy, Clinical development, Regulatory affairs
Sacramento, California, United States · On-site
$60k–$90k/yr
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 ser…
Skills: Logistics coordination, Supply chain management, Real-time problem solving, Chain-of-custody documentation, KPI tracking
Sacramento, California, United States · On-site
$85k–$105k/yr
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 ser…
Skills: Process monitoring, Troubleshooting, GMP manufacturing, Root cause analysis, Validation protocols
Menlo Park, California, United States · On-site
$100k–$160k/yr
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 ser…
Skills: Statistical leadership, Analytical method development, Comparability assessment, Tolerance interval methodologies, Bland-Altman analysis
Sacramento, California, United States · On-site
$70k–$90k/yr
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 ser…
Skills: GMP manufacturing, Equipment troubleshooting, CMMS, Asset maintenance, Calibration
Sacramento, California, United States · On-site
$23/hr–$29/hr
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 ser…
Skills: Quality assurance, cGMP compliance, Documentation review, Aseptic technique, Environmental monitoring
Menlo Park, California, United States · On-site
$250k–$300k/yr
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 ser…
Skills: Regulatory affairs, Strategic planning, Lifecycle management, FDA regulations, EMA regulations
Menlo Park, California, United States · Remote OK
$120k–$160k/yr
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 ser…
Skills: Data infrastructure, Business intelligence, KPI development, Market research, Competitive intelligence
Menlo Park, California, United States · Remote OK
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 ser…
Skills: Medical Affairs Leadership, KOL Management, Clinical Research, Publication Planning, Medical Communications
Sacramento, California, United States · On-site
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 ser…
Skills: Logistics Planning, Scheduling, Vendor Coordination, Administrative Coordination, Batch Documentation
Sacramento, California, United States · On-site
$60k–$90k/yr
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 ser…
Skills: Logistics Coordination, Chain of Custody Documentation, Vendor Management, Real-time Problem Solving, Transport Monitoring
Princeton, New Jersey, United States · On-site
$70k–$90k/yr
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 ser…
Skills: cGMP Manufacturing, Aseptic Techniques, Cell Therapy, Process Optimization, People Leadership
Princeton, New Jersey, United States · On-site
$80k–$100k/yr
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 ser…
Skills: Process Monitoring, Troubleshooting, Validation Protocols, Root Cause Analysis, Change Control
Princeton, New Jersey, United States · On-site
$70k–$90k/yr
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 ser…
Skills: Quality Control Testing, Flow Cytometry, Cell-Based Assays, cGMP Compliance, Aseptic Techniques
Menlo Park, California, United States · Remote OK
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 ser…
Skills: Account Management, Cell Therapy, Oncology, Hematology, Stakeholder Management
Sacramento, California, United States · On-site
$85k–$105k/yr
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 ser…
Skills: Packaging Engineering, Cold Chain Management, Cryopreservation, cGMP Compliance, Labeling Management
Sacramento, California, United States · On-site
$36/hr–$43/hr
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 ser…
Skills: Quality Assurance, Deviation Management, Change Control, CAPA, Document Management
Sacramento, California, United States • On-site
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Responsible for leading process validation activities specifically within the cell therapy manufacturing environment. Ensures all validation protocols and reports meet quality assurance standards and regulatory requirements.
Requires professional experience in process validation within the biotechnology or cell therapy sector. Candidates must demonstrate a strong understanding of quality assurance principles and regulatory compliance.
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.
\nPhysical DemandsThe 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.
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.
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.
Transforming allogeneic cell therapy for patients with cancer and autoimmune diseases.
Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. Our investigational products are designed to replace a patient’s diseased blood and immune system with a healthy one. Our manufacturing platform uses single-cell precision to create proprietary, uniquely-defined products that have the potential to revolutionize allogeneic cell therapy. Our team of leading scientists, engineers and clinicians is united in our mission to transform the lives of patients. Together, we are working to deliver the promise of a cure, without the compromise. Please note, a member of the Orca Bio team will only ever communicate using an @orcabio.com email address.
Offices: 3475 Edison Way, Suite B, Menlo Park, CA 94025, US · 3400 Business Dr, 140, Sacramento, California 95820, US
Transforming allogeneic cell therapy for patients with cancer and autoimmune diseases.
Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. Our investigational products are designed to replace a patient’s diseased blood and immune system with a healthy one. Our manufacturing platform uses single-cell precision to create proprietary, uniquely-defined products that have the potential to revolutionize allogeneic cell therapy. Our team of leading scientists, engineers and clinicians is united in our mission to transform the lives of patients. Together, we are working to deliver the promise of a cure, without the compromise. Please note, a member of the Orca Bio team will only ever communicate using an @orcabio.com email address.
Offices: 3475 Edison Way, Suite B, Menlo Park, CA 94025, US · 3400 Business Dr, 140, Sacramento, California 95820, US
