Scientist, Quality Control

Orca Bio•Princeton, NJ

2d•Onsite

About The Position

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. We are establishing manufacturing operations on the East Coast to ensure the consistent and reliable delivery of our high-precision cell therapy products. 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.

Requirements

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
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.

Nice To Haves

Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred.

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