uBriGene (MA) Biosciences Inc.
AD / QC Scientist – Cell & Gene Therapy Product Release
uBriGene (MA) Biosciences Inc., Germantown, Maryland, us, 20875
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. Key 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 panel. 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 requirements. 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. Qualifications:
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). Desired Skills:
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. Why uBriGene?
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.
#J-18808-Ljbffr
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. Key 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 panel. 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 requirements. 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. Qualifications:
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). Desired Skills:
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. Why uBriGene?
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.
#J-18808-Ljbffr