CMC Program Lead, Cell Therapy & Biologics

Oryon Cell Therapies; Boston (MA); On-site; USD 190,000 - 230,000; Full time

Job summary

Oryon Cell Therapies seeks a CMC Program Lead to orchestrate an integrated CMC development plan spanning Product Sciences, Process Development, Analytical Development, manufacturing, and regulatory CMC. You will chair program reviews, partner with the CTO, and guide external supplier governance from clinical development to BLA readiness.

The role demands strong CMC breadth across process, analytical, and regulatory disciplines with matrix leadership experience and a track record of advancing

Qualifications

• 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.
• Director: Typically 12+ years of relevant industry experience, Senior Director: 15+ years.

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 technical rigor and alignment with the development strategy.
• Anticipate downstream consequences of process, analytical, manufacturing, and regulatory decisions and identify risks to the critical path.
• 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 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 external development and manufacturing partners, including scope and escalation of issues.
• Support manufacturing strategy, technology transfer, pivotal supply planning, and future manufacturing-site decisions.
• Ensure comparability, process characterization, validation, and manufacturing-readiness activities are integrated with planned changes.
• Establish fit-for-purpose operating mechanisms for expanding CMC organization and development documentation.
• Represent the integrated CMC program in cross-functional planning, external partnerships, and technical diligence.

Skills

CMC program leadership

Cross-functional collaboration

Regulatory strategy

Program governance

Strategic decision framing

Education

PhD or MS in chemical engineering, bioengineering, cell biology, pharmaceutical sciences, or related

Experience in biologics/cell/gene therapies development

Integrated CMC program leadership in clinical development

Breadth across CMC (process, analytical, manufacturing, quality, regulatory)

Regulatory CMC experience (IND/CTA, BLA)

Experience leading cross-functional matrix teams

Director/Senior leadership with 12+ / 15+ years

Job description

Oryon Cell Therapies seeks a CMC Program Lead to orchestrate an integrated CMC development plan spanning Product Sciences, Process Development, Analytical Development, manufacturing, and regulatory CMC. You will chair program reviews, partner with the CTO, and guide external supplier governance from clinical development to BLA readiness.

The role demands strong CMC breadth across process, analytical, and regulatory disciplines with matrix leadership experience and a track record of advancing