Director / Senior Director, CMC Program Lead

Position Summary

The CMC Program Lead will lead the integrated CMC development program for Oryon’s autologous iPSC-derived dopaminergic neuron therapy. Reporting to the Chief Technical Officer, this individual will translate CMC strategy into an executable development plan spanning Product Sciences, Process Development, Analytical Development, manufacturing, and regulatory CMC.

The mandate extends from the current clinical-stage process through pivotal development and BLA readiness. The CMC Program Lead will define the critical path, integrate cross-functional dependencies, frame major development decisions, and ensure that the evidence required for each stage of development is generated at the right time.

This is a matrix leadership role. Functional leaders retain ownership of their respective scientific and technical areas; the CMC Program Lead owns integration across them. This individual will chair CMC program and development gate reviews, serve as a strategic thought partner to the Chief Technical Officer, and provide technical and program leadership for key external development and manufacturing relationships.

Level will be determined by experience.

Key Responsibilities
• Build and maintain the integrated CMC development strategy and critical path from the current clinical process through pivotal development, validation, and BLA readiness
• Translate program objectives into clear development stages, decision points, evidence requirements, dependencies, and timelines across CMC functions
• Lead cross-functional CMC program and development gate reviews, ensuring that major decisions are technically rigorous, appropriately documented, and aligned with the overall development strategy
• Anticipate downstream consequences of process, analytical, manufacturing, and regulatory decisions and identify risks to the critical path before they become program constraints
• Integrate Process Development, Analytical Development, Product Sciences, manufacturing, quality, and regulatory activities into a coherent development program
• Lead the integration and execution of regulatory CMC strategy in partnership with the Chief Technical Officer and Regulatory Affairs, including agency interactions, IND amendments, and BLA Module 3 planning
• Establish and maintain the integrated CMC risk framework, decision history, and development assumptions
• Lead technical governance of key external development and manufacturing partners, including scope, deliverables, technical performance, and escalation of critical issues
• Support manufacturing strategy, technology transfer, pivotal supply planning, and future manufacturing-site decisions
• Ensure comparability, process characterization, validation, and manufacturing-readiness activities are prospectively integrated with planned process and analytical changes
• Establish fit-for-purpose operating mechanisms for an expanding CMC organization, including integrated planning, technical governance, and development documentation
• Represent the integrated CMC program in cross-functional development planning, external partnerships, and technical diligence

Qualifications

Required
• PhD or MS in chemical engineering, bioengineering, cell biology, pharmaceutical sciences, or a related discipline
• Significant experience developing complex biologics, cell therapies, gene therapies, or other advanced therapeutic products
• Demonstrated experience leading an integrated CMC program or equivalent cross-functional technical development effort through clinical development
• Strong technical breadth across CMC, with the judgment to identify dependencies and tradeoffs across process, analytical, manufacturing, quality, and regulatory disciplines
• Experience developing integrated CMC plans encompassing process development, analytical development, comparability, process characterization, validation, and manufacturing readiness
• Experience contributing to regulatory CMC strategy, agency interactions, and IND/CTA amendments or marketing application preparation
• Experience leading cross-functional teams in a matrix environment in which scientific and functional leaders retain ownership of their disciplines
• Experience managing external development or manufacturing partners through technical governance and program execution
• Demonstrated ability to frame complex technical decisions, articulate alternatives and risks, and drive decisions to resolution
• Excellent written and verbal communication skills, including the ability to synthesize complex technical programs for senior leadership
• Director: Typically 12+ years of relevant industry experience, including substantial responsibility for integrated CMC development during clinical development
• Senior Director: Typically 15+ years of relevant industry experience, with significant CMC leadership through late-stage development and BLA/MAA preparation or approval

Technical Experience

Depth in several of the following areas is expected:
• Autologous cell therapy process development and technology transfer
• Analytical development, control strategy, specifications, and comparability
• Process characterization, validation, and process performance qualification
• Regulatory CMC for biologics or advanced therapies
• GMP manufacturing and manufacturing sciences
• Pivotal and commercial manufacturing readiness
• External manufacturing and supplier governance

Preferred
• Experience with pluripotent stem cell-derived or neural cell products
• Experience leading CMC programs through pivotal development
• Experience supporting a BLA/MAA, pre-license inspection, or commercial launch
• Experience establishing development systems and governance within a growing biotechnology company
• Experience translating academic or founder-led technologies into disciplined product-development programs