QC Analyst – Cell & Gene Therapy Product Release
Germantown, MD
Full Time
Mid Level
Job Title: QC Analyst – Cell & Gene Therapy Product Release
Location: Germantown MD
Company: uBriGene Biosciences
About 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:
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.
Location: Germantown MD
Company: uBriGene Biosciences
About 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.
- Bachelor'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.
- 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.
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.
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