Scientist, Quality Control (2nd/3rd Shift)
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 are establishing manufacturing operations on the East Coast 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.
The Scientist, Quality Control 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. The incumbent compiles data for documentation of test procedures, calibrates and maintains lab and analytical equipment; and participates in the preparation of investigations, summaries and reports. The Scientist reviews data obtained for compliance with specifications and reports abnormalities; revises and updates standard operating procedures as needed. May perform special projects.
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
- 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
Minimum Qualifications:
- Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) required; Master's degree preferred
- 2-4 years of experience in quality control testing, analytical development, or biologics GMP
- Adhere to cGMP policies and procedures, including documentation activities
- Able to wear appropriate personal protective equipment
- Moderate understanding of analytical techniques, laboratory equipment, and quality control principles
- Some experience in aseptic techniques, flow cytometry, or cell-based assays
- Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred.
- Able to meet project and testing timelines
- Detail-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 challenges
- Ability to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment
- 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
- Flexibility to work outside standard business hours when needed to support site priorities, deadlines, or critical business needs.
- Monday - Friday, 4:00pm - 12:30am
- Monday - Friday, 12:00am - 8:30am
2nd Shift:
3rd Shift:
Physical Demands
- 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.