Senior Scientist / Principal Scientist, Analytical Development

Oryon Cell Therapies; Boston (MA); On-site; USD 120,000 - 200,000; Full time

Job summary

Oryon Cell Therapies seeks an Analytical Development Scientist to create release and characterization methods for autologous iPSC-derived dopaminergic neuron therapy. You'll help build the analytical control strategy and collaborate with Product Sciences and Process Development.

The role spans flow cytometry, potency, molecular analytics, and regulatory-compliant validation, including ICH-guided studies. You will contribute to the lab build-out and partner with academic collaborators to advance

Qualifications

• 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

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

Skills

Flow cytometry

Potency assays

qPCR/ddPCR

NGS-based methods

In-process controls

Biostatistics

Education

PhD in cell biology or related field

MS with commensurate experience

Tools

LIMS

qPCR instruments

NGS platforms

Flow cytometers

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