About this opportunity
Oryon Cell Therapies lists this Senior Scientist / Principal Scientist, Analytical Development opportunity in boston, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
The Analytical Development Scientist will develop the analytical methods that release and characterize Oryon's autologous iPSC-derived dopaminergic neuron therapy. Reporting to the Chief Technical Officer, this individual will help build the analytical control strategy for the program.
The method set covers starting material, intermediates, and drug product. It spans cell-based approaches, including flow cytometry, potency, and in-process controls, as well as molecular approaches, including quantitative detection of residual undifferentiated cells, genomic stability, and molecular identity. The team will work closely with Product Sciences, Process Development, and our academic collaborators. Level will be determined by experience.
Key Responsibilities
Develop, optimize, and qualify release, in-process, and stability methods across identity, purity, potency, and safety attributes
Establish testing and acceptance criteria for patient starting material and process intermediates
Transfer analytical methods from academic collaborators into Oryon laboratories
Develop the potency assay through qualification, in collaboration with Product Sciences
Design in-process controls suited to a closed manufacturing process, where speed and operator execution are design requirements
Establish reference materials, controls, and system suitability criteria
Execute method qualification and validation consistent with ICH and latest regulatory guidance
Own the stability program, including the stability master plan and study execution
Conduct analytical risk and gap assessments and set method development priorities accordingly
Lead method transfer to quality control and contract testing laboratories, and manage outsourced testing
Identify and evaluate emerging analytical technologies that can improve sensitivity, speed, or analytical performance
Support authoring of protocols, technical reports, qualification and validation documents, and analytical content for regulatory submissions
Assist with laboratory build-out and support establishment of laboratory systems and workflows
Qualifications
Required
PhD in cell biology, immunology, neuroscience, molecular biology, biochemistry, or related field, or MS with commensurate experience
Senior Scientist: 6+ years (fewer with an advanced degree). Principal Scientist: 10+ years, including ownership of an analytical control strategy for a cell or gene therapy product
Hands-on analytical development experience for cell or gene therapy products, with depth in at least three of the following:
Multi-color flow cytometry, including panel design, gating strategy, and qualification
Cell-based or surrogate potency assays
Quantitative molecular methods (qPCR, ddPCR, NGS-based)
Detection of residual rare cell populations
Genomic stability and integrity assessment
In-process controls, intermediate testing, or starting material characterization for a cell therapy process
Imaging-based or high-content methods
Bioinformatics for sequencing-based methods
Method qualification, validation, and transfer under a quality system
Strong data analysis and technical writing skills, including statistical tools for method development
Preferred
Stem cell / iPSC or neural cell product experience
Experience developing a potency assay through qualification
Experience with contract testing laboratories and QC groups
Familiarity with automated sample preparation, LIMS, or analytical data systems
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Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.