Sr. Research Specialist (All Children's - School of Medicine)

Johns Hopkins University•St. Petersburg, FL

1d•Onsite

About The Position

We are seeking Sr. Research Specialist to join the lab at Johns Hopkins All Children's Hospital in St. Petersburg, Florida. The Sr. Research Specialist will serve as the technical partner in establishing a cell therapy pilot and R&D program with a CliniMACS Prodigy–based closed-system pipeline. In collaboration with multiple investigators, the specialist will assist in authoring end-to-end SOPs and integrating documentation and QC frameworks across multiple modalities (e.g., CAR-T, NK, dendritic, stem-cell–derived products) while contributing to the design and optimization strategy. The Sr. Research Specialist makes intellectual contributions to the scientific research interests of the laboratory. In collaboration with a PI, makes decisions that may alter research objectives and direction. Performs a range of sophisticated assays. Contributes to writing peer-reviewed manuscripts and funding proposals.

Requirements

Bachelor's Degree in Biology, Chemistry or related field.
Four years of experience in a comparable laboratory performing relevant techniques.
Experience with Miltenyi CliniMACS Prodigy or similar closed-system cell-processing platforms.
Experience with CAR-T, NK, dendritic cell, or stem-cell–derived therapeutic products and their process/assay development.
Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Nice To Haves

Master's Degree with related graduate research.
Authoring, version control, and training on SOPs, batch records, and deviation/CAPA documentation for cell-therapy process development.
Experience using electronic batch records (eBR), QMS and/or LIMS for chain-of-identity/chain-of-custody and data integrity.
Experience with cell-therapy QC assays: endotoxin, mycoplasma, sterility (R&D context), residual beads/cytokines, and basic potency-style readouts (e.g., cytotoxicity assays, activation markers).
Familiarity with environmental monitoring (EM) programs, equipment/facility qualification, and assay qualification/transfer for preclinical/development labs.
Experience with basic statistics and graphing software (e.g., Prism/Excel or similar).

Responsibilities

Develop, design and manage substantial research projects, and coordinate their own objectives.
Perform sophisticated data analysis utilizing an extensive knowledge base and experience with varied methods. In a clinical laboratory, perform and develop clinical validation protocols.
Act as a consultant to refine or adapt methodologies to fit research objectives.
Collaborate in the development of new technologies, protocols, and uses of equipment.
Contribute original thoughts, hypotheses, and analysis to write reports, abstracts, and manuscripts.
Function scientifically in the laboratory comparably to a post-doctoral fellow.
Independently perform assays specific to the laboratory interests.
May provide oversight and direction to staff, including interviews, recommendations for hiring and evaluation of performance.
Enhance problem solving through interactions and discussions with collaborators or senior researchers at meetings and/or professional presentations.
Make decisions regarding laboratory projects that may require assessment, revision of objectives, or altering scientific direction.
Consider resources and laboratory priorities when making decisions.
Other duties as assigned.
Maintain detailed, contemporaneous electronic and paper records for all cell-therapy runs, experiments, and QC assays.
Organize, label, and track donor/patient samples, intermediates, and final cell products, coordinate storage and retrieval with biorepository and clinical teams.
Manage inventory of Prodigy consumables, reagents, and general lab supplies; anticipate needs and place/track orders.
Maintain logbooks and coordinate preventive maintenance, calibration, and service visits for Prodigy, flow cytometers, incubators, and related equipment.
Use aseptic technique in biosafety cabinets, including handling of primary human cells and viral vectors.
Perform maintenance and basic troubleshooting of core lab equipment (BSCs, CO incubators, cryo freezers, automated cell counters, flow analyzers) and coordinate on of preventive maintenance/calibration.
Design, execute, and analyze multicolor flow cytometry panels.
Perform daily flow cytometer QA/QC (startup, CS&T/PMT or equivalent, compensation, controls, instrument logs) and standardized reporting.
Conduct qPCR/ddPCR–based assays for vector copy number (VCN), identity, or other nucleic-acid–based release-like tests.
Assist in training and onboarding of students, fellows, and staff on SOPs, aseptic technique, and safe handling of viral vectors and primary human samples.
Contribute to routine lab/program meetings by presenting run summaries, troubleshooting findings, and proposed process improvements.