About this opportunity
Oryon Cell Therapies lists this Director / Senior Director, CMC Program Lead opportunity in boston, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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
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Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.