Scientist, Quality Control (2nd/3rd Shift)
On-sitePrinceton, New Jersey, United States
Job Summary
Conduct routine and non-routine quality control testing on raw materials, process intermediates, and final cell therapy products using established protocols, including flow cytometry and cell-based assays. Record and document all activities accurately in compliance with cGMP regulations while assisting in the preparation of batch records, standard operating procedures, and reports. Perform routine lab maintenance, calibrate equipment, and prepare complex reagents, including aseptic aliquoting. Identify technical problems and participate in assay transfer and validation efforts. Work collaboratively with cross-functional teams to support overall product quality. The role involves 2nd or 3rd shift hours (4:00pm–12:30am or 12:00am–8:30am) Monday through Friday. Requires a Bachelor's degree in a relevant scientific discipline and 2-4 years of experience in quality control testing or biologics GMP.
Required Qualifications
- Bachelor's degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.)
- 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
- 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
- Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision
- Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods
- Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom
- Any skin conditions that cause shedding must be disclosed
Desired Qualifications
- Master's degree preferred
- Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment
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