Scientist, Quality Control

Orcabiosystems; Princeton (NJ); On-site; USD 85,000 - 110,000; Full time

Job summary

Orcabiosystems is seeking a Scientist, Quality Control to perform routine and non-routine analyses supporting cell therapy product development and manufacturing. You will compile data, calibrate and maintain lab equipment, and contribute to investigations and reports.

The role requires a Bachelor’s degree in a relevant science and 2–4 years of QC/GMP experience, with aseptic technique and flow cytometry familiarity welcomed.

Qualifications

• Bachelor's degree in biology, biochemistry, immunology, or a related field; Master’s degree preferred.
• 2–4 years of quality control testing, analytical development, or biologics GMP experience.
• Adherence to cGMP policies and documentation practices.
• Ability to wear appropriate PPE and operate in a regulated lab.
• Experience with aseptic techniques and cell-based assays.

Responsibilities

• Perform routine QC testing on raw materials, intermediates, and final products using established protocols.
• Conduct a broad range of cell-based assays, including flow cytometry, to support operations.
• Record and document all QC testing activities in compliance with cGMP and SOPs.
• Assist in preparing and reviewing batch records and SOPs.
• Maintain and qualify laboratory equipment; prepare reagents as needed.
• Participate in assay transfer and validation; identify and resolve technical issues.
• Collaborate with manufacturing, R&D, and QA to ensure product quality.

Skills

Quality control testing

Analytical techniques

Flow cytometry

Aseptic techniques

Data integrity

Effective communication

Education

Bachelor’s degree in biology / biochemistry / immunology

Master’s degree preferred

Tools

Flow cytometer

Job description

Job Summary

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.

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 and 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

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
• Adherence to cGMP policies and procedures, including documentation activities
• Ability 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
• Ability 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
• Ability 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
• Effective communication skills with team members and contribution to a positive and collaborative work environment
• 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

We’re proud to be an equal‑opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.