uBriGene Biosciences Inc. · 3 weeks ago
AD / QC Scientist – Cell & Gene Therapy Product Release
Germantown, MD
Full-time
Onsite
Mid, Senior Level
3+ years expuBriGene Biosciences Inc. is a leading Contract Development and Manufacturing Organization specializing in cell and gene therapy manufacturing. They are seeking a motivated QC Scientist to play a critical role in the release testing of cell and gene therapy products in a GMP environment.
Biotechnology
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
Qualification
Required
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
Preferred
Experience with designing and setting up multicolor flow assays
Bilingual is preferred (English & Mandarin)
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
Company
uBriGene Biosciences Inc.
uBriGene Biosciences is your bridge from ATMPs concept to commercialization.
11-50 employees
Funding
Current Stage
Late StageTotal Funding
$94.83M2024-12-24Series D· $27.41M
2023-04-19Series C· $21.78M
2022-12-23Series C· $14.66M
Recent News
BioProcess International
2024-05-03
2023-12-19
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