Night-Shift Quality Control Scientist — Cell Therapy

Orca-Bio; California (MO); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Pre-IPO equity

Medical, dental, vision benefits

PTO (paid time off)

401(k) plan

Parental leave

Subsidized meals

Job summary

Orca Bio in Sacramento, CA is seeking a Scientist, Quality Control - Night Shift to perform routine and non-routine biochemical and chemical analyses of processes leading up to drug product, ensuring compliance with cGMP and documenting results.

The role focuses on calibrating equipment, preparing SOPs, contributing to investigations, and collaborating with manufacturing, R&D, and QA to uphold product quality and data integrity.

Qualifications

• Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) required
• 2-4 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 experience
• Moderate understanding of analytical techniques, laboratory equipment, and quality control principles
• Some experience in aseptic technique, 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

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

Skills

Flow cytometry

Cell-based assays

Aseptic technique

Quality control principles

Data integrity

Team collaboration

Education

Bachelor’s degree in a relevant scientific discipline

Tools

Laboratory equipment

Job description

Orca Bio in Sacramento, CA is seeking a Scientist, Quality Control - Night Shift to perform routine and non-routine biochemical and chemical analyses of processes leading up to drug product, ensuring compliance with cGMP and documenting results.

The role focuses on calibrating equipment, preparing SOPs, contributing to investigations, and collaborating with manufacturing, R&D, and QA to uphold product quality and data integrity.