Scientist, Analytical Development

Company Description

Oryon Cell Therapies is a clinical-stage biotechnology company developing autologous cell therapies for neurodegenerative disorders, with an initial focus on Parkinson’s disease. Oryon’s approach centers on replacing neurons lost to disease, with the goal of functional restoration for people living with Parkinson’s. The team works at the intersection of cellular therapeutics, neuroscience, and translational research to move innovative therapies into the clinic. Candidates joining Oryon will be part of a growing organization focused on rigorous science and meaningful patient impact.

Position Summary

The Scientist / Senior Scientist, Analytical Development will lead laboratory efforts supporting transfer, development, qualification, and implementation of analytical methods for an autologous iPSC-derived dopaminergic neuron therapy.

Reporting to the Head of Technical Development, this individual will serve as a primary technical contributor responsible for transferring analytical methods from academic collaborators and building the foundation of the company's analytical control strategy towards GMP manufacturing and clinical development.

This position requires a strong combination of cell biology expertise, assay development experience, and flexibility to support multiple aspects of technical operations within a startup environment.

Key Responsibilities

Analytical Technology Transfer

• Transfer analytical methods from academic collaborators into company laboratories
• Establish assay reproducibility and method performance
• Generate method transfer protocols and reports
• Evaluate assay suitability for eventual GMP transfer and implementation

Assay Development

• Lead development and optimization of key in-process and release assays, such as safety, identity, purity, viability, and potency
• Transfer, develop, execute and interpret characterization assays (flow cytometry, immunocytochemistry, qPCR, ddPCR, ELISA, imaging-based assays, cell-based functional assays)
• Stability-indicating methods

Control Strategy Development

• Support establishment of critical quality attributes (CQAs)
• Generate data supporting specification development
• Contribute to comparability studies
• Support assay qualification and validation planning

Manufacturing Support

• Collaborate with manufacturing and MSAT teams during GMP process implementation
• Assist with investigations, deviations, and root cause analyses

Documentation

• Author protocols, technical reports, SOPs, development reports, technology transfer and qualification / validation documents
• Maintain accurate laboratory records and data packages

Startup Contributions

• Assist with laboratory build-out and equipment qualification
• Support establishment of laboratory systems and workflows
• Contribute wherever needed to advance company objectives

Qualifications

Required

• PhD in biomedical engineering or related field with 5+ years industry experience or MS with 5-8 years industry experience
• Hands-on industry assay development experience in cell-based (potency) assays, flow cytometry, safety (genomic stability) and molecular biology methods
• Strong data analysis and technical writing skills
• Demonstrated track record of successful assay qualification planning and execution

Preferred

• GMP experience
• IND experience
• Stem cell / iPSC experience

Characteristics

·     Exceptionally detail-oriented

·     Strong experimentalist

·     Comfortable with ambiguity

·     Practical problem solver

·     Willing to work across functions

Local travel between Oryon labs (Watertown) and academic collaborator (Belmont) required.