Full-Time
IT & Manufacturing Systems Specialist
IT & Manufacturing Systems Support
Orca Bio
201-500 employees
Develops and commercializes safer cell therapies
Compensation Overview
$71k - $90k/yr
Sacramento, CA, USA
In Person
Occasional on-site hardware/troubleshooting at the Sacramento facility; primary dutyRequires on-site weekend shifts.
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- 2+ years of experience in an IT Helpdesk, Technical Support, or Systems Support role (Level 1/2 troubleshooting)
- Ability to work non-traditional hours, specifically overnight shifts (10:00 PM - 6:00 AM / 6:00 PM - 6:00 AM) and weekends (Saturday/Sunday)
- Exceptional attention to detail with the ability to follow rigorous, step-by-step technical instructions for resolving technical issues and updating system configuration and electronic Batch Records (eBRs)
- Experience with identity management/SSO tools and IT ticketing systems
- Experience troubleshooting label printing software (e.g., Bartender) and hardware (Brady, Zebra) issues
- Prior experience working within a regulated GMP manufacturing environment is highly preferred, but a strong understanding of compliance, data integrity, and 21 CFR Part 11 requirements is required
- Prior experience with MasterControl (MX/QX modules) or MES system (e.g. TrakSYS) is a plus, but not required, with comprehensive training provided
- Provide Level 1 and Level 2 troubleshooting for critical manufacturing applications (e.g., TrakSYS, MasterControl, and enterprise systems) during graveyard and weekend shifts
- Resolve urgent issues that are impacting the manufacturing process such as access issues, password lockouts, workflow restarts, and label printing issues
- Triage, document, and escalate complex hardware or software issues to corresponding Tier 3 IT or system owners when immediate resolution is not possible
- Support weekend and off-shift activities as part of a 24/7 coverage model, with specific shift availability required for weekends (10:00 PM – 6:00 AM) and weekdays (6:00 PM – 6:00 AM)
- Act as an off-shift drafting and testing resource for electronic Batch Records (eBR), following explicit, structured directions to update step references and system parameters
- Assist with basic, standardized tasks within the MasterControl Manufacturing Excellence (MX) and Quality Excellence (QX) modules
- Serve as off-shift MasterControl Administration and Document Control owner to ensure production documentation moves seamlessly through the pipeline. E.g., process MC tickets including account creation, termination and role assignments
- Support data entry and system routing tasks per established Good Manufacturing Practices (GMP) and data integrity guidelines
- Occasionally provide on-site hardware or system troubleshooting at the manufacturing facility during weekend shifts if needed, though routine work can be managed remotely
- Prior experience working within a regulated GMP manufacturing environment is highly preferred
- Strong understanding of compliance, data integrity, and 21 CFR Part 11 requirements is required
- Prior experience with MasterControl (MX/QX modules) or MES system (e.g. TrakSYS) is a plus, but not required, with comprehensive training provided
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
Series F
Total Funding
$542M
Headquarters
Menlo Park, California
Founded
2016
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Simplify's Take
What believers are saying
- June 30, 2026 approval unlocks first-revenue commercialization across select centers immediately.
- January 9, 2026 financing added $250 million plus $100 million credit capacity.
- Orca plans about 25 treatment centers by year-end, expanding access and physician familiarity.
What critics are saying
- April 1, 2026 FDA extended Orca-T review after CMC questions, signaling manufacturing scrutiny.
- Tregzi's label warns graft failure, secondary malignancies, infections, and transmission risks.
- Commercial launch depends on complex matched-donor logistics; execution failures can choke adoption by 2027.
What makes Orca Bio unique
- June 30, 2026 FDA approved Tregzi, validating Orca Bio's precision-engineered transplant platform.
- Precision-T showed 78% chronic GVHD-free survival versus 38% with conventional transplant.
- Princeton, New Jersey manufacturing and Sacramento operations support bicoastal, patient-specific cell delivery.
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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
↑ 5%2 year growth
↓ -1%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.