Scientist, Quality Control
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 protocolsPerform 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 assaysRecord and document all quality control testing activities accurately and in compliance with cGMP regulations and company proceduresAssist in the preparation and review of batch records, standard operating procedures (SOPs), and other relevant documentationPerform routine lab maintenance, including equipment qualification / maintenancePrepare basic and complex reagents as assignedOrder and maintain lab supply inventoryAliquot samples as required, including aseptic aliquotingParticipate in assay transfer and assay validationIdentify and support resolution of technical problemsActively participate in group and project teamwork; project and process improvementsReceive and provide trainingPerform other duties as requested by supervisor / manager to support QualityWork collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy productsBehavioral and Operational Expectations
Communicate effectively with team members and contribute to a positive and collaborative work environmentActively participate in group and project teamwork; project and process improvementsStrong organizational skills and the ability to manage multiple tasks concurrentlyWillingness to learn and adapt in a fast-paced, dynamic environmentAdhere to cGMP policies and procedures, including documentation activitiesWillingness to work overtime as requiredAble to wear appropriate personal protective equipmentMinimum Experience, Education, Certifications, Licenses
Bachelor's degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) required2-4 years of experience in quality control testing, analytical development, or biologics GMP preferred; candidates with less experience may be considered for Associate Scientist role.Master's degree may substitute for years of experienceModerate understanding of analytical techniques, laboratory equipment, and quality control principlesSome experience in aseptic technique, flow cytometry, or cell-based assaysPreferred experience in method validation, including writing protocols, executing studies, and generating reportsExperience with characterization of biopharmaceutical products, including stability testing and critical quality attribute (CQA) analysis preferredExperience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferredAble to meet project and testing timelinesDetail-oriented with a commitment to data integrity and accuracy, and an ability to identify problems with data management.Able to work collaboratively to respond to changing priorities and challengesAbility to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment65,000 - $95,000 a year
The anticipated annual salary range for this job is based on prior experience in the role / industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to competitive medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations.
