Scientist, Quality Control

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 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 operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.
The QC Scientist conducts routine and non-routine analysis, including but not limited to biochemical and chemical analysis of processes leading up to drug product according to established operating procedures. Compiles data for documentation of test procedures. Calibrates and maintains lab and analytical equipment. Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports abnormalities. Revises and updates standard operating procedures as needed. May perform special projects.

Physical Demands

• Production Associates: 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.
• 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.

Work Conditions

• Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
• Must be comfortable regularly participating in video-based meetings.
• May be required to work scheduled overtime, weekends, or holidays based on business needs.

Essential Duties & Key Responsibilities

• Perform routine quality control testing on raw materials, process intermediates, and final cell therapy products using established protocols
• Perform a broad variety of basic and moderate complex tests in support of lab operations, including but not limited to flow cytometry and other cell-based assays
• Record and document all quality control testing activities accurately and in compliance with cGMP regulations and company procedures
• Assist in the preparation and review of batch records, standard operating procedures (SOPs), and other relevant documentation
• Perform routine lab maintenance, including equipment qualification/maintenance
• Prepare basic and complex reagents as assigned
• Order and maintain lab supply inventory
• Aliquot samples as required, including aseptic aliquoting
• Participate in assay transfer and assay validation
• Identify and support resolution of technical problems
• Actively participate in group and project teamwork; project and process improvements
• Receive and provide training
• Perform other duties as requested by supervisor/manager to support Quality
• Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products

Behavioral and Operational Expectations

• Communicate effectively with team members and contribute to a positive and collaborative work environment
• Actively participate in group and project teamwork; project and process improvements
• Strong organizational skills and the ability to manage multiple tasks concurrently
• Willingness to learn and adapt in a fast-paced, dynamic environment
• Adhere to cGMP policies and procedures, including documentation activities
• Willingness to work overtime as required
• Able to wear appropriate personal protective equipment

Minimum Experience, Education, Certifications, Licenses

• Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, im