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Orca Bio

Develops and commercializes safer cell therapies

EHS Specialist - Environment, Health & Safety

Full-TimeUpdated on 10/23/2026
$75k - $105k/yr+ Pre-IPO equity + Annual bonus
Senior
Bachelor's
Sacramento, CA, USA
In PersonOn-site at Sac02 3–4 days/week and nearby Sac01 1–2 days/week; occasional Menlo Park travel 1–2 days/month.
Facilities OperationsEnvironmental Health & Safety

About the job

Requirements
  • A bachelor's degree in Environmental Science, Occupational Health & Safety, Industrial Hygiene, or a related field is preferred.
  • Five years of EHS experience in a GMP environment; experience in a cell therapy, biotechnology, or pharmaceutical manufacturing facility is preferred.
  • Working knowledge of Cal/OSHA, EPA, DTSC, CDPH, and other relevant regulations.
  • Project and time management skills to manage multiple priorities in a fast-paced environment.
  • Analytical skills, attention to detail, problem-solving skills, and the ability to make sound decisions.
  • On-site presence is required, with regular office hours and possible on-call availability and after-hours presence for planned or unplanned work or emergency response.
  • Gowning is required for cleanroom access.
  • Must meet cleanroom gowning requirements, including wearing full gowning for up to three consecutive hours and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays.
  • Use of cosmetics, jewelry, or facial piercings is not permitted in the cleanroom, and skin conditions that cause shedding must be disclosed.
Responsibilities
  • Ensure compliance with Cal/OSHA, EPA, DTSC, CDPH, and other applicable regulatory standards.
  • Conduct safety audits, inspections, and risk assessments to identify and mitigate safety, health, and environmental risks, and coordinate implementation of identified corrective actions or improvements.
  • Lead safety committees and represent EHS interests in cross-functional meetings and project teams.
  • Develop, coordinate, and deliver EHS training programs for employees, including HazCom, LOTO, PPE, and emergency response.
  • Investigate near-misses, incidents, and injuries; recommend and track corrective actions; and manage associated documentation and reporting requirements.
  • Develop, maintain, and update EHS policies, procedures, and documentation.
  • Manage environmental programs, including waste management, air emissions, and wastewater compliance.
  • Manage the proper handling, storage, disposal, documentation, and regulatory compliance of biohazardous and hazardous wastes.
  • Track and report safety metrics and environmental data.
  • Support emergency preparedness and response planning.
  • Collaborate with leadership to drive continuous improvement in safety performance.
  • Maintain EHS documentation, including SDSs, permits, and reporting.
  • Lead or support emergency response plans, drills, and preparedness activities.
Desired Qualifications
  • Certifications such as OSHA, HAZWOPER, CSP, or CHMM are a plus.
  • Must have visual acuity of 20/20, corrected or uncorrected, and normal color vision to perform visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
  • Must be comfortable regularly participating in video-based meetings.

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

1%

1 year growth

3%

2 year growth

0%
Associated Press
Jul 1st, 2026
FDA approves Tregzi, first donor immune cell therapy cutting serious transplant complications in blood cancer patients by 70%

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.

Fierce Pharma
Jul 1st, 2026
Orca Bio secures FDA approval for $428K cell therapy Tregzi, eyes potential IPO

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.

Associated Press
Jun 30th, 2026
Orca Bio's TREGZI becomes first FDA-approved precision cell therapy for blood cancer transplants

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.

San Francisco Biotechnology Network
Jun 15th, 2026
Orca Bio expands Sacramento workforce, adds East Coast manufacturing site ahead of approval.

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

Business Wire
Jun 15th, 2026
Orca Bio expands manufacturing for Orca-T launch with East Coast facility and tripled workforce

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.