Scientist, Quality Control

About the role

The Scientist, Quality Control position at Orca Bio is essential to advancing the clinical pipeline and supporting the future commercial availability of the company's life-saving cell therapy products. This role is part of a team working to develop next-generation cell therapies that aim to improve survival rates and reduce risks associated with traditional allogeneic stem cell transplants.

Responsibilities

• Perform routine quality control testing on raw materials, process intermediates, and final cell therapy products using established protocols
• 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
• 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
• Collaborate with cross-functional teams to support the overall quality of cell therapy products
• Perform other duties as requested by supervisor/manager to support Quality

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
• 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
• 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

Qualifications

• Visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks
• Ability to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles)

Skills

• Strong organizational skills
• 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

Benefits

Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.

Pay

$70,000 - $90,000 a year

Schedule

Full-time employment positions