Astrix ยท 4 weeks ago
Cell Culture Scientist
Bethesda, MD
Full-time
Onsite
Mid Level
$85K/yr - $90K/yrAstrix is involved in manufacturing cell and gene therapies for clinical trials, and they are seeking a Cell Culture Scientist. The role focuses on building and optimizing a cGMP compliant platform for stem cell generation, managing GMP facility operations, and preparing regulatory documents for the FDA.
ConsultingInformation Technology
Hiring Manager
Justin Galloway
Responsibilities
Build and optimize a robust cGMP compliant platform for generation, expansion and cryopreservation of autologous induced pluripotent stem cells (iPSCs) from peripheral blood derived CD34+ cells
Differentiate iPSCs to retinal pigment epithelial cells (RPE) to develop an iRPE patch for a phase I clinical trial to treat "dry" age related macular degeneration
Update and validate SOPs related to CD34 expansion, iPSC culturing, and RPE differentiation
Manage a day to day operation of GMP facility
Maintain iPSC colonies and freeze their early passages
GMP and aseptic culturing of iPCSs and differentiation of patient iPSCs into Retinal pigment epithelium (RPE) and maintenance of those RPE cultures. This work will include:
Preparing media, supplements, and reagents needed cell culture work
Maintaining the cell culture room biosafety level 2 standards and maintaining aseptic conditions in cell culture flow hoods, incubators, and prepare sterile tools needed for work with cell cultures
The cell culture maintenance work will require working for short periods of times on the weekends and some holidays
Work to characterize the iPSC colonies for their pluripotency. This will require:
Immunostaining of iPSCs, preparing RNA and cDNA from iPSCs, and Performing qRT-PCR assays
Additionally they will perform three germ layer assay based functional characterization of iPSCs. This work will also include any cell types that act as control for his iPSC work
Prepare regulatory documents for FDA and technology transfer
Coordinate transfer of lab-technology to Good Manufacturing Practice (GMP suite)
Develop Standard Operating Procedures (SOPs) with the Contract Research Organization (CRO) in relation to the cell therapy project
Qualification
Required
Prior cell culture experience is required
Prior experience working in a cGMP environment is required
Company
Astrix
Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.
Founded in 1995
1001-5000 employees
H1B Sponsorship
Astrix has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (10)
2024 (9)
2023 (10)
2022 (16)
2021 (11)
Funding
Current Stage
Late StageLeadership Team
Dale Curtis
Chief Executive Officer
Reid E. Simpson
Chief Financial Officer
Recent News
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