Program Manager, CRDMO

We are seeking a Program Manager to drive cell and gene therapy Contract Research, Development, and Manufacturing Organization (CRDMO) programs within an Integrated Project Delivery (IPD) framework.

This role supports the full product development lifecycle — from biological design and process development through pivotal manufacturing and regulatory submission — operating as a shared-accountability leader embedded within a unified, cross-functional project team.

The ideal candidate brings deep technical expertise, a collaborative leadership style, and the agility to co-own outcomes with sponsors, internal partners, and external parties under IPD principles of transparency, early risk surfacing, and joint decision-making.

We are seeking a Program Manager to drive cell and gene therapy Contract Research, Development, and Manufacturing Organization (CRDMO) programs within an Integrated Project Delivery (IPD) framework.

This role supports the full product development lifecycle — from biological design and process development through pivotal manufacturing and regulatory submission — operating as a shared-accountability leader embedded within a unified, cross-functional project team.

The ideal candidate brings deep technical expertise, a collaborative leadership style, and the agility to co-own outcomes with sponsors, internal partners, and external parties under IPD principles of transparency, early risk surfacing, and joint decision-making.

• Lead the workstream within the Integrated Project Team (IPT), co-owning program outcomes with Synthetic Biology, Process Development, Analytical Development, MSAT, Quality Control, GMP Manufacturing, Regulatory Affairs, Finance and sponsor partners.
• Facilitate IPT working sessions and Joint Steering Committee (JSC) meetings; frame decisions with full context, scenario analysis, and downstream impact.
• Champion IPD principles: shared risk/reward, open-book collaboration, and joint decision-making across all workstreams.
• Drive escalation to governance committees at the right level and time; iterate on PMO frameworks, risk registers, and project review boards to improve oversight.
• Lead end-to-end program execution, including therapeutic design, process and analytical development, pivotal readiness, method qualification/validation, pilot & engineering run strategies, and regulatory submission readiness.
• Drive cross-functional alignment across SynBio, PD, AD, MSAT, QC, and GMP Manufacturing to ensure process consistency, data integrity, and regulatory compliance.