What are the responsibilities and job description for the Quality Control Scientist position at United Pharma Technologies Inc?
Job Title: QC Scientist – Cell & Gene Therapy
Location: Bridgewater, New Jersey
Industry: Biotechnology / Pharmaceutical
Position Overview:
We are seeking a highly motivated and detail-oriented Quality Control (QC) Scientist to support our growing Cell & Gene Therapy operations. The ideal candidate will have hands-on experience in aseptic techniques, microbiology, QC microbiology, and QC chemistry in a GMP-regulated environment. This role is critical to ensuring the quality and safety of our innovative cell and gene therapy products.
Key Responsibilities:
- Perform microbiological and chemical testing of raw materials, in-process samples, and final drug products.
- Execute environmental monitoring (EM) and aseptic process simulation (APS) in classified cleanroom areas.
- Support QC Microbiology and QC Chemistry functions, including sterility testing, endotoxin testing, bioburden, and pH/conductivity testing.
- Ensure all testing is performed in compliance with GMP, GLP, and regulatory requirements.
- Maintain accurate and complete laboratory documentation according to Good Documentation Practices (GDP).
- Participate in investigations, deviations, and CAPAs related to QC activities.
- Assist in method qualification, validation, and transfer for cell and gene therapy products.
- Collaborate with manufacturing, quality assurance, and R&D teams to support product release and continuous improvement efforts.
Qualifications:
- Bachelor’s or Master’s degree in Microbiology, Chemistry, Biotechnology, or a related life sciences field.
- 2 years of experience in a QC laboratory environment within the biologics or advanced therapy medicinal products (ATMPs) industry.
- Solid knowledge of aseptic techniques and cleanroom practices.
- Experience with cell therapy and/or gene therapy products strongly preferred.
- Familiarity with USP, EP, FDA, and ICH guidelines.
- Excellent documentation and communication skills.
- Ability to work independently and collaboratively in a fast-paced environment.
Preferred Skills:
- Experience with rapid micro methods and advanced QC analytical platforms.
- Knowledge of GMP regulations applicable to cell and gene therapy manufacturing.
- Comfortable working in a regulated cleanroom environment.
