Scientist – Quality Control
About the job
- A bachelor's degree in a relevant scientific discipline, such as biology, biochemistry, or immunology, is required; a master's degree is preferred.
- Two to four years of experience in quality control testing, analytical development, or biologics good manufacturing practice is required.
- Adhere to current good manufacturing practice policies and procedures, including documentation activities.
- Be able to wear appropriate personal protective equipment.
- Have a moderate understanding of analytical techniques, laboratory equipment, and quality control principles.
- Have some experience in aseptic techniques, flow cytometry, or cell-based assays.
- Experience in quality control or good manufacturing practice within a cell therapy or biopharmaceutical manufacturing environment is preferred.
- Be able to meet project and testing timelines.
- Be detail-oriented, committed to data integrity and accuracy, and able to identify problems with data management.
- Work collaboratively to respond to changing priorities and challenges.
- Work independently and collaboratively with a multidisciplinary team in a fast-paced, regulated environment.
- Communicate effectively with team members and contribute to a positive, collaborative work environment.
- Actively participate in group and project teamwork, project and process improvements.
- Have strong organizational skills and the ability to manage multiple tasks concurrently.
- Be willing to learn and adapt in a fast-paced, dynamic environment.
- Be flexible to work outside standard business hours when needed to support site priorities, deadlines, or critical business needs.
- Meet cleanroom gowning requirements, including wearing full gowning for up to three consecutive hours, working with or around human blood and other biological materials, and following restrictions on cosmetics, jewelry, and facial piercings; disclose any skin conditions that cause shedding.
- Be comfortable regularly participating in video-based meetings.
- Perform routine quality control testing on raw materials, process intermediates, and final cell therapy products using established protocols.
- Perform basic and moderately complex tests in support of laboratory operations, including flow cytometry and other cell-based assays.
- Accurately record and document all quality control testing activities in compliance with current good manufacturing practice regulations and company procedures.
- Assist in preparing and reviewing batch records, standard operating procedures, and other relevant documentation.
- Perform routine laboratory maintenance, including equipment qualification and maintenance.
- Prepare basic and complex reagents as assigned.
- Aliquot samples as required, including aseptic aliquoting.
- Participate in assay transfer and assay validation.
- Identify and support resolution of technical problems.
- Participate in group and project teamwork, project and process improvements.
- Receive and provide training.
- Perform other duties as requested by the supervisor or manager to support Quality.
- Work collaboratively with manufacturing, research and development, and quality assurance teams to support the overall quality of cell therapy products.
- Conduct routine and non-routine biochemical and chemical analysis of processes leading up to drug product according to established operating procedures.
- Compile data documenting test procedures, calibrate and maintain laboratory and analytical equipment, and participate in preparing investigations, summaries, and reports.
- Review data for compliance with specifications, report abnormalities, revise and update standard operating procedures as needed, and perform special projects as assigned.
- A master's degree in a relevant scientific discipline is preferred.
- Experience in quality control or good manufacturing practice within a cell therapy or biopharmaceutical manufacturing environment is preferred.
About the company
Orca Bio develops and commercializes cell therapies to improve outcomes for patients. It works by researching, developing, and producing therapies that use the body’s own cells to treat diseases, with products sold to healthcare providers who administer them to patients. The company aims to enhance the safety and effectiveness of cell therapies, making treatments more reliable for conditions that lack good options. Orca Bio differentiates itself through its focus on delivering safer, more effective therapies and by fostering a strong team culture with active stakeholder communication, including a regularly updated newsroom. Overall, its goal is to expand access to improved cell therapies and become a leading player in the cell therapy market.
Company Size
201-500
Company Stage
Debt Financing
Total Funding
$542M
Headquarters
North Fair Oaks, California
Founded
2016
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Simplify's Take
What believers are saying
- FDA approval on June 30, 2026 validates Orca Bio's platform and pipeline.
- The company raised $250 million in December 2025, funding launch and expansion.
- Princeton capacity and Sacramento hiring support commercialization and faster nationwide patient delivery.
What critics are saying
- TREGZI costs $428,000, forcing transplant centers and payers into tough coverage fights.
- Complex donor-specific manufacturing can bottleneck supply, delaying launches beyond the planned 25 centers.
- Any post-marketing safety signal or FDA CMC issue would cripple Orca Bio's only commercial product.
What makes Orca Bio unique
- Orca Bio's TREGZI won FDA approval on June 30, 2026, first precision cell therapy.
- Its donor-derived regulatory T-cell design directly reduces chronic GVHD after transplant.
- Princeton and Sacramento manufacturing create a bicoastal vein-to-vein network for personalized production.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Unlimited Paid Time Off
401(k) Retirement Plan
Parental Leave
Growth & Insights and Company News
6 month growth
0%1 year growth
3%2 year growth
0%The US Food and Drug Administration has approved Tregzi, the first regulatory T cell-based immunotherapy for improving chronic graft-versus-host disease-free survival in adult blood cancer patients undergoing stem cell transplantation. The treatment uses donor-derived immune cells to help fight cancer whilst reducing the risk of chronic GVHD, a serious complication where transplanted donor cells attack the patient's body. In the PRECISION-T trial involving 187 patients, 78% of those receiving Tregzi achieved chronic GVHD-free survival at one year, compared to 38.4% receiving standard transplants. Only 12.6% of Tregzi patients developed serious chronic GVHD within one year versus 44% in the control group. The treatment, developed by Orca Biosystems, received Orphan Drug and Regenerative Medicine Advanced Therapy designations.
Orca Bio has secured FDA approval for Tregzi, a first-of-its-kind engineered cell therapy for blood cancer patients requiring transplants. The allogeneic regulatory T cell-based immunotherapy is approved as an alternative stem cell transplant to improve survival free of chronic graft-versus-host disease in adults with hematological malignancies. In the phase 3 Precision-T trial involving 187 patients, 78% who received Tregzi were alive and free from chronic GVHD at one year, compared to 38% with standard transplants—a 74% improvement. Overall survival was 94% versus 83%. Orca is pricing Tregzi at $428,000 wholesale acquisition cost. The company recently raised $250 million and is launching at select centres, aiming for 25 by year-end. CEO Nate Fernhoff said the company is "well capitalised" for launch but didn't rule out a future IPO.
Orca Bio has received US FDA approval for TREGZI, the first precision-engineered cell therapy for matched-donor hematopoietic stem cell transplantation in adults with hematological malignancies. The therapy uses donor cells to reconstitute the immune system whilst suppressing graft-versus-host disease (GVHD). The approval is based on the Phase 3 Precision-T study of 187 patients with acute myeloid leukaemia, acute lymphoblastic leukaemia, myelodysplastic syndrome and mixed-phenotype acute leukaemia. Results showed 78% chronic GVHD-free survival at 12 months with TREGZI compared to 38% with conventional transplant. Overall survival was 94% versus 83%, whilst non-relapse mortality was 3% compared to 13%. TREGZI is a personalised treatment manufactured for each patient using living cells from a matched donor.
Orca Bio expands Sacramento workforce, adds East Coast manufacturing site ahead of approval. June 15, 2026 san francisco biotechnology network news news, syndication comments off on orca Bio expands Sacramento workforce, adds East Coast manufacturing site ahead of approval. Orca Bio, a biotechnology company that works in precision cell therapy, has expanded its Sacramento workforce and added an East Coast manufacturing center in Princeton, New Jersey, as it prepares for commercialization. Click here to view original post
Orca Bio has expanded its manufacturing capabilities ahead of the potential launch of its lead cell therapy, Orca-T, adding East Coast manufacturing capacity in Princeton, New Jersey, and tripling its West Coast manufacturing workforce in Sacramento, California. The Princeton facility will serve as a strategic East Coast manufacturing bridge, initially producing therapies for ongoing clinical programmes and supporting commercial production following potential FDA approval. The bicoastal network aims to reduce "vein-to-vein" time for patients nationwide. Orca Bio has more than tripled its Sacramento operations team over the past year, enhancing expertise in manufacturing, supply chain logistics and quality assurance. Orca-T's Biologics License Application is under FDA review, with a target action date of 6 July 2026.