QC Specialist II — Cell & Gene Therapy QC (2nd/3rd Shift)

MADE Scientific Inc; Princeton (NJ); On-site; USD 85,000 - 125,000; Full time

Job summary

Made Scientific Inc. in Princeton, NJ seeks a QC Specialist II on 2nd/3rd shift to support in-process and release testing for CGT products. The role includes stability studies, microbiology, analytical testing, and ensuring on-time results in a GMP environment.

The ideal candidate has a Master’s degree with GMP experience or a BA with substantial QC exposure, and is capable of leading analytical method transfers and investigations with strong collaboration skills.

Qualifications

• Master’s Degree with 2+ years in GMP focusing on microbiology and analytical methods or a Bachelor’s with 3+ years of relevant experience.
• In-depth knowledge of microbiology methods, aseptic techniques, and analytical assays.
• Extensive QC experience with compendial methods and regulatory guidance.
• Ability to learn and perform new microbiological and analytical assays as needs evolve.
• Ability to manage multiple priorities in a fast-paced environment.
• Willingness to work flexible hours including evenings and weekends.

Responsibilities

• Perform analytical and microbiological testing of CGT products in a cGMP environment.
• Lead trainer and SME on analytical methods (Flow cytometry, PCR, ELISAs) and mentor junior staff.
• Coordinate QC lab operations, inventory, and compliance with GMP requirements.
• Review records for in-process monitoring, product release, and stability testing.
• Lead investigations of OOS results and propose corrective actions.
• Support method transfers, validation, and regulatory compliance.

Skills

Flow Cytometry

PCR

ELISAs

Aseptic techniques

Analytical assays

Team collaboration

Education

Master’s Degree in a relevant field

Bachelor’s degree in a relevant field

Tools

LIMS

Job description

Made Scientific Inc. in Princeton, NJ seeks a QC Specialist II on 2nd/3rd shift to support in-process and release testing for CGT products. The role includes stability studies, microbiology, analytical testing, and ensuring on-time results in a GMP environment.

The ideal candidate has a Master’s degree with GMP experience or a BA with substantial QC exposure, and is capable of leading analytical method transfers and investigations with strong collaboration skills.