AD / QC Scientist – Cell & Gene Therapy Product Release

uBriGene (MA) Biosciences Inc. • Germantown, MD

3d

About The Position

About Us: uBriGene is a leading Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapy manufacturing. We are committed to providing comprehensive solutions delivering high-quality products, testing and filing, to support drug developers at every stage of their journey and to accelerate the development, manufacturing and commercialization of life-changing therapies. We are looking for a motivated QC Scientist 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.

Requirements

• PHD's degree in Biology, Biochemistry, immunology or a related field.
• 3-5 years of GMP QC testing experience, or assay development experience is plus
• Experience in GMP product release is highly preferred.
• Hands-on experience with flow cytometry, qPCR, ddPCR, ELISA.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 collaborative team player.
• Experience with designing and setting up multicolor flow assays.
• Bilingual is preferred (English & Mandarin).

Nice To Haves

• Smoothly operate multi-color flow cytometer, perform and analyze multi-color biomarker flow panel.
• Perform qPCR, ddPCR, ELISA.
• 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.

Responsibilities

• Perform QC release testing for cell and gene therapy products, including flow cytometry, qPCR, endotoxin, viability assays and functional potency assays.
• Must be able to properly operate flow cytometers, run and analyze multi-color biomarkers flow panels.
• Perform stem cell product-related assays, including cell differentiation culture, defining cell surface/nuclear markers by 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 keep compliance of cell and gene therapy products requirement.
• Maintain QC data and records using Microsoft Office software and other relevant systems.
• Given the GMP nature of the role, some weekend work is expected, and compensatory time off will be granted.

Benefits

• At uBriGene, we offer an innovative and collaborative work environment where you will contribute to the development of cutting-edge cell and gene therapies. We are passionate about fostering professional growth and delivering impactful solutions for our clients.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 501-1,000 employees