Cell & Gene Therapy QC Specialist - GMP

Made Scientific, Inc.; Princeton (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

Made Scientific, Inc. in Princeton, NJ seeks a QC Specialist II to support in-process and release testing for Cell and Gene Therapy products, delivering high-quality results in a CGMP environment.

You will lead analytical methods, mentor junior staff, and coordinate QC lab operations, while reviewing records and participating in method transfers, validation, CAPAs, and environmental monitoring to ensure regulatory compliance.

Qualifications

• Master’s Degree with 2+ years in a GMP environment focusing on microbiology and analytical methods, OR a bachelor’s degree with 3+ years of relevant experience.
• Hands-on microbiology methods, aseptic techniques and analytical assays including Flow Cytometry, PCR, and ELISAs.
• Extensive QC experience with compendial methods and regulatory guidance.
• Ability to learn and perform new microbiological and analytical assays as team needs evolve.
• Able to thrive in a fast-paced environment, manage multiple priorities, and adapt to changing demands.

Responsibilities

• Perform analytical and microbiological testing of CGT products (Sterility, Mycoplasma, Endotoxin, Flow Cytometry, Cell Count, Potency).
• Serve as lead trainer on analytical methods (Flow Cytometry, PCR, ELISAs) and mentor junior staff.
• Coordinate GMP QC lab operations and inventory, ensuring compliance with policies.
• Troubleshoot issues impacting lab operations, test methods, equipment, or facilities.
• Coordinate method transfers and validation to ensure regulatory compliance.
• Review records for in-process monitoring, product release, and stability testing.

Skills

Microbiology

Aseptic techniques

Environmental Monitoring

GMP knowledge

Analytical methods

Documentation

Verbal and written communication

Education

Master’s degree in a relevant field

Bachelor’s degree in a relevant field

Tools

LIMS

Flow cytometry instrumentation

PCR equipment

ELISA kits

Job description

Made Scientific, Inc. in Princeton, NJ seeks a QC Specialist II to support in-process and release testing for Cell and Gene Therapy products, delivering high-quality results in a CGMP environment.

You will lead analytical methods, mentor junior staff, and coordinate QC lab operations, while reviewing records and participating in method transfers, validation, CAPAs, and environmental monitoring to ensure regulatory compliance.