Research Associate, Analytical Development

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 versus host disease. Orca Bio is a late‑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 investigational 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.

• Production Associate Roles:
  Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color‑coded components in a GMP environment.
• Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

• Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video‑based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.

Orca Bio is seeking a Contract Research Associate to support the Analytical Development team. This lab‑based role will contribute to the characterization, qualification, and validation of analytical methods used to support the development of cell therapy products. The successful candidate will perform hands‑on laboratory studies, maintain accurate documentation, and collaborate with a multidisciplinary team to advance analytical method development and validation.

• Participate in a team focused on the characterization, qualification, and validation of analytical methods for cell therapy products.
• Execute laboratory‑based studies to develop, optimize, qualify, and validate analytical methods for the analysis of cell therapy products.
• Generate, analyze, and accurately document experimental data in accordance with established procedures and quality standards.
• Author and review laboratory documentation, including standard operating procedures (SOPs), analytical methods, qualification and validation protocols, technical reports, and other laboratory processes.
• Collaborate with cross‑functional teams to support analytical development activities and project timelines.
• Maintain laboratory equipment, reagents, and work spaces while adhering to laboratory safety and compliance requirements.

• Hands‑on experience with analytical techniques such as:
  • Flow cytometry
  • Mammalian cell culture and aseptic technique
  • ELISA and other immunoassays
  • qPCR/PCR
  • Cell viability and cell counting assays
  • Cell‑based functional assays (e.g., proliferation, activation, cytotoxicity)
  • Fluorescence or brightfield microscopy
• Experience with data analysis software such as Flow Jo, Graph Pad Prism, and Microsoft Excel.
• Familiarity with analytical method qualification and validation.
• Experience working in a regulated laboratory environment (GLP, GMP, or similar) is a plus.

• Salary: $24 - $30 an hour.
• Benefits may include medical, dental, vision coverage, PTO, 401(k) plan, life and accidental death and disability coverage, parental leave benefits, and subsidized daily lunches and snacks at on‑site locations.

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.