QC Analyst - Cell & Gene Therapy Product Release
: Job Details :

Job Title: QC Analyst - Cell & Gene Therapy Product ReleaseLocation: Germantown MDCompany: uBriGene BiosciencesAbout Us:uBriGene is a leading CDMO specializing in cell and gene therapy manufacturing. We are committed to delivering high-quality products to support clinical and commercial pipelines in the biotech industry.We are looking for a motivated QC Analyst to join our team and play a critical role in the release testing of cell and gene therapy products in a GMP environment. If you are passionate about cutting-edge biotechnology and thrive in a fast-paced environment, this could be the perfect role for you.Key Responsibilities:

• Perform QC release testing for cell and gene therapy products, including flow cytometry, qPCR, endotoxin, and viability assays.
• Execute flow cytometry assays, with experience in multi-color panel analysis being a plus.
• Perform stem cell product-related assays, including cell differentiation culture, cell surface/nuclear marker flow cytometry, immunofluorescence staining, and imaging.
• Draft, review, and maintain Standard Operating Procedures (SOPs), worksheets, and QC release reports.
• Collaborate with Analytical Development (AD), Process Development (PD), and MSAT teams to perform method suitability and qualification studies.
• Set up, calibrate, and maintain QC instruments (e.g., drafting SOPs, performing Preventive Maintenance (PM), and conducting IQ/OQ/PQ).
• Ensure compliance with GMP guidelines and regulatory requirements for product release.
• Work effectively with cross-functional teams to ensure timely release and compliance of cell and gene therapy products.
• Maintain QC data and records using Microsoft Office software and other relevant systems.

Qualifications:

• Master's degree or above in Biology, Biochemistry, or a related field.
• 1-2 years of GMP QC testing experience, preferably in a CDMO environment.
• Experience in GMP product release is highly preferred.
• Hands-on experience with flow cytometry, qPCR, endotoxin, and viability assays.
• Knowledge of QC instrument maintenance and qualification (PM, calibration, IQ/OQ/PQ).
• Proficiency with Microsoft Office (Excel, Word, etc.).
• Self-motivated and able to adapt to a fast-paced work environment.
• Strong communication skills and the ability to work as a cooperative team player.

Desired Skills:

• Experience with multi-color flow cytometry panel analysis.
• Prior experience in a CDMO setting is a plus.
• Experience in immune and stem cell culture, as well as cell product potency assays, is a plus.

Why uBriGene?At uBriGene, we offer an innovative and collaborative work environment where you will contribute to the cutting-edge development of cell and gene therapies. We are passionate about fostering professional growth and delivering impactful solutions for our clients.Application Instructions:Interested candidates should submit their resume and cover letter.