Head of Technology 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

Head of Technical Development

The Head of Technical Development will provide scientific and technical leadership for the development and commercialization of an autologous iPSC-derived dopaminergic neuron therapy for Parkinson's disease.

The individual will lead the transfer of process and analytical methods from an academic institution into an industrial development environment and will build the scientific foundation for process development, analytical development, manufacturing scale-out, and regulatory submissions.

This role will serve as a key member of the Technical Operations leadership team and will report directly to the CTO.

Primary Responsibilities

Technology Transfer

• Lead transfer of cell therapy manufacturing processes from an academic partner into company laboratories
• Establish comprehensive process understanding across reprogramming, iPSC expansion, differentiation, cryopreservation and administration formulation
• Identify process gaps and development opportunities required for GMP production into Phase 3 and commercial readiness
• Develop technology transfer plans, protocols, reports, and risk assessments
• Transfer internal process into GMP manufacturing

Process Development Leadership

• Build and lead internal process development capabilities and lab operations
• Define process characterization strategy and comparability plans
• Identify critical process parameters and critical quality attributes
• Work closely with Quality, Regulatory, MSAT / Manufacturing and other functions to move internally optimized process into GMP manufacturing

Analytical Development Partnership

• Work closely with analytical development teams to establish key assays (identity, purity, potency, safety)
• Ensure biological relevance of analytical methods
• Help establish product specifications

Product Characterization

• Develop deep understanding of iPSC biology and methods for reprogramming, dopaminergic neuron differentiation, including impact of resultant cell populations, identity, product heterogeneity and mechanism of action
• Serve as internal scientific expert regarding product biology

Regulatory Support

• Contribute to source documents, FDA meetings, IND amendments, comparability packages, CMC sections
• Support scientific justifications for development decisions

Team Building

• Recruit and manage process development scientists, cell biologists, research associates
• Manage external consultants and academic collaborators
• Must be flexible, creative, entrepreneurial and able to thrive in a start-up environment

Qualifications

Education

·     PhD in Cell Biology, Stem Cell Biology, Biomedical Engineering / Bioengineering or a related discipline

Experience

·     10-15 years industry experience with depth in cell therapy, including direct experience in iPSC and neuronal cell culture

·     Experience in cell therapy development, process and analytical development, technology transfer, CMC support

·     Working understanding of DOE, CPP identification, process characterization, scale-up/scale-out

·     Demonstrated success in a transferred a process between sites, from academia to industry and from development to GMP

·     Managed 5-15 scientists, CROs/CDMOs, external academic collaborators

·     Direct experience defending process changes to FDA for manufacturing, facility and raw material changes

Requires frequent local travel between Oryon labs (Watertown, MA) and collaborators (Belmont, MA).