Cell Research Engineer (Bethesda)
Astrix, Bethesda, MD, United States
This is a research role , specifically supporting iPSC (induced pluripotent stem cell or sometimes written as HiPSC or human induced pluripotent stem cell) therapies, not other cell therapies like CAR-T. Only seeking candidates with iPSC or HiPSC research experience and cell culture experience.
ROLES / RESPONSIBILITES
Serve as a Research Engineer for a Cell Therapy projects.
Cell Culture (~20%):
Culturing primary human fibroblasts from patients with retinal degenerative diseases.
Catalog and freeze early passages of these fibroblasts.
Will reprogram these fibroblasts into induced pluripotent stem cells (iPSCs) using standard available techniques.
Will maintain iPSC colonies and freeze their early passages.
Differentiation of patient iPSCs into retinal pigment epithelium (RPE), endothelial cells, and organoids, and maintenance of those RPE and endothelial cultures. This work will include:
Preparing media, supplements, and reagents needed for cell culture work.
Maintaining the cell culture room biosafety level 2 standards and maintaining aseptic conditions in cell culture flow hoods, incubators, and preparing sterile tools needed for work with cell cultures.
The cell culture maintenance work will require working for short periods of time on the weekends and some holidays.
Work to characterize the iPSC colonies for their pluripotency. This will require:
Immunostaining 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 iPSC work. Other experiments needed to perform these assays utilize one or several of the following techniques: immunoblot analysis, immunohistochemistry, immunofluorescence staining, scanning electron microscopy, PCR, real-time PCR, RNA and protein extraction, ELISA, FACS, and total tissue resistance measurements.
Will document (imaging and analyses) their results and compile them for presentations and publications.
Will participate in lab meetings and discussions, present their work and the relevant literature, and help in the lab organization.
Will help with the other ongoing projects in the lab with the expertise developed on iPSC projects
Lab Management: ordering and supply inventory (20%):
Will oversee lab organization, supplies, and reagent inventory, and maintenance of cell culture room.
Oversee repairs, replacement, etc. of laboratory equipment, interacting appropriately with procurement, secretarial, and other staff with related responsibilities.
Experience with GLP/GMP manufacturing of cells (20%):
Familiarity with Good Manufacturing Practices (GMP) guidelines.
Provide conceptual and technical assistance to staff in understanding and implementing the FDA GMP guidelines.
Ensure compliance with GMP; guide staff.
Personnel management and training (10%):
Train personnel; train research associates, post-doctoral fellows, visiting scientists, students, and other assigned personnel in specialized laboratory techniques, procedures, and laboratory safety, especially concerning radioactive, biohazardous, or other hazardous materials.
Coordinate and oversee laboratory personnel to achieve needed tasks.
Complies with and enforces safe laboratory practices, hazardous materials handling, and follows established safety guidelines and disseminates safety standards to all staff.
Exercise independent judgment in performing a full range of responsibilities in support of the ongoing research of the laboratory/section.
Cell therapy manufacturing for CRADA (10%):
Optimize and develop allo-iPSC-RPE products for comparability studies with auto-iPSC-RPE product
Perform comparability between allo- and auto-iPSC-RPE using the following assays – flow cytometry, ReShape, SEM, phagocytosis, gene expression, and TER
Manufacture GLP-grade allo-iPSC-RPE for preclinical tox studies
Assist in completing IND-write up for allo-iPSC-RPE
Coordinate tech transfer of allo-iPSC-RPE to the clinical center for use in a phase I clinical trial
Administrative skills - helping Principal Investigator with collaborations and keeping track of collaborative and lab project progress (20%):
Work to develop Standard Operating Procedures (SOPs) with the Contract Research Organization (CRO).
Serve as a lead professional on committees/work groups; serve as a conduit of information between these workgroups.
Coordinate meetings between all parties working on the cell therapy project so they can brief us about the progress they have made for their respective parts of the project.
Organize internal and external meetings by setting up meeting agendas, taking meeting notes, and sending out meeting minutes.
DESIRED BACKGROUND
BS degree in relevant field is required; MS degree is desirable
Knowledge of stem cells, cell therapy, cell culture techniques
Knowledge of the eye is highly desirable
Familiarity with Good Manufacturing Practices (GMP) guidelines in preferred
ROLES / RESPONSIBILITES
Serve as a Research Engineer for a Cell Therapy projects.
Cell Culture (~20%):
Culturing primary human fibroblasts from patients with retinal degenerative diseases.
Catalog and freeze early passages of these fibroblasts.
Will reprogram these fibroblasts into induced pluripotent stem cells (iPSCs) using standard available techniques.
Will maintain iPSC colonies and freeze their early passages.
Differentiation of patient iPSCs into retinal pigment epithelium (RPE), endothelial cells, and organoids, and maintenance of those RPE and endothelial cultures. This work will include:
Preparing media, supplements, and reagents needed for cell culture work.
Maintaining the cell culture room biosafety level 2 standards and maintaining aseptic conditions in cell culture flow hoods, incubators, and preparing sterile tools needed for work with cell cultures.
The cell culture maintenance work will require working for short periods of time on the weekends and some holidays.
Work to characterize the iPSC colonies for their pluripotency. This will require:
Immunostaining 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 iPSC work. Other experiments needed to perform these assays utilize one or several of the following techniques: immunoblot analysis, immunohistochemistry, immunofluorescence staining, scanning electron microscopy, PCR, real-time PCR, RNA and protein extraction, ELISA, FACS, and total tissue resistance measurements.
Will document (imaging and analyses) their results and compile them for presentations and publications.
Will participate in lab meetings and discussions, present their work and the relevant literature, and help in the lab organization.
Will help with the other ongoing projects in the lab with the expertise developed on iPSC projects
Lab Management: ordering and supply inventory (20%):
Will oversee lab organization, supplies, and reagent inventory, and maintenance of cell culture room.
Oversee repairs, replacement, etc. of laboratory equipment, interacting appropriately with procurement, secretarial, and other staff with related responsibilities.
Experience with GLP/GMP manufacturing of cells (20%):
Familiarity with Good Manufacturing Practices (GMP) guidelines.
Provide conceptual and technical assistance to staff in understanding and implementing the FDA GMP guidelines.
Ensure compliance with GMP; guide staff.
Personnel management and training (10%):
Train personnel; train research associates, post-doctoral fellows, visiting scientists, students, and other assigned personnel in specialized laboratory techniques, procedures, and laboratory safety, especially concerning radioactive, biohazardous, or other hazardous materials.
Coordinate and oversee laboratory personnel to achieve needed tasks.
Complies with and enforces safe laboratory practices, hazardous materials handling, and follows established safety guidelines and disseminates safety standards to all staff.
Exercise independent judgment in performing a full range of responsibilities in support of the ongoing research of the laboratory/section.
Cell therapy manufacturing for CRADA (10%):
Optimize and develop allo-iPSC-RPE products for comparability studies with auto-iPSC-RPE product
Perform comparability between allo- and auto-iPSC-RPE using the following assays – flow cytometry, ReShape, SEM, phagocytosis, gene expression, and TER
Manufacture GLP-grade allo-iPSC-RPE for preclinical tox studies
Assist in completing IND-write up for allo-iPSC-RPE
Coordinate tech transfer of allo-iPSC-RPE to the clinical center for use in a phase I clinical trial
Administrative skills - helping Principal Investigator with collaborations and keeping track of collaborative and lab project progress (20%):
Work to develop Standard Operating Procedures (SOPs) with the Contract Research Organization (CRO).
Serve as a lead professional on committees/work groups; serve as a conduit of information between these workgroups.
Coordinate meetings between all parties working on the cell therapy project so they can brief us about the progress they have made for their respective parts of the project.
Organize internal and external meetings by setting up meeting agendas, taking meeting notes, and sending out meeting minutes.
DESIRED BACKGROUND
BS degree in relevant field is required; MS degree is desirable
Knowledge of stem cells, cell therapy, cell culture techniques
Knowledge of the eye is highly desirable
Familiarity with Good Manufacturing Practices (GMP) guidelines in preferred