Manager CMC Program Operations

Intellia•Cambridge, MA

About The Position

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done. We want all of our people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together. As Intellia continues to advance its pipeline, this newly created role reflects the organization's commitment to operational excellence, scalable project management, and digital transformation within CMC. The Manager, the CMC Program Operations will serve as the operations and digital enablement lead for CMC teams, partnering directly with the Commercial CMC Team Lead to build and maintain integrated project plans, dashboards, and reporting tools that drive execution. This role goes beyond traditional project coordination, it is responsible for designing and deploying practical, generative and agentic AI-enabled tools (e.g., smart dashboards, auto-generated status reports, risk-flagging models) that improve visibility, reduce manual tracking burden, and accelerate decision-making across CMC workstreams. The Manager will drive cross-functional coordination, track program risks, manage regulatory commitment timelines, and act as the primary operations point of contact for the commercial CMC teams, with opportunity to influence broader platform and portfolio operations.

Requirements

Strong project management fundamentals (MS Project, Smartsheet, or similar) with proven critical-path and risk-management experience.
Demonstrated experience using AI/automation tools to build practical operational solutions (e.g., using generative AI, low-code/no-code platforms, scripting, or BI tools like Power BI/Tableau to automate reporting, summarize data, or flag risks).
Working knowledge of GMP, quality, supply chain, and regulatory requirements in a biopharma/cell & gene therapy context.
Proven ability to influence without authority across matrixed, cross-functional teams.
Excellent written/verbal communication and stakeholder management skills.
High attention to detail, strong organizational skills, and comfort operating in a fast-paced, ambiguous environment.
Bachelor’s degree in a relevant field
6+ years in biopharmaceutical/life sciences, including CMC development (cell & gene therapy preferred), with 2+ years in dedicated CMC or operations project management.
Hands-on experience building or deploying AI-enabled or automated tools to support program/operations reporting is strongly preferred

Nice To Haves

PMP certification preferred

Responsibilities

Build and maintain a master CMC project plan (MS Project, Smartsheet, or equivalent), identifying task interdependencies, critical path, and monitoring mechanisms for schedule risk.
Design and implement AI-assisted or automated tools (e.g., dashboard automation, natural-language status summarization, predictive risk flagging) to reduce manual reporting effort and increase real-time visibility into program health.
Publish recurring dashboards and executive-ready reporting to align the team on progress, critical path changes, and emerging risks.
Actively participate in CMC team meetings — set agendas, capture minutes, track action items, and drive follow-through.
Maintain the CMC risk register; apply a structured framework for risk identification, scoring, mitigation, and escalation, and facilitate risk review forums.
Partner with Regulatory, Process Development, Manufacturing, Supply Chain, and Quality representatives to ensure RtQ/PAC commitments are clearly defined, assigned, and tracked.
Coordinate with RegCMC on post-approval commitment (PAC) tracking and provide leadership with regular status reporting, flagging gaps or delays.
Identify opportunities to modernize CMC operations workflows through digital tools and automation; pilot and scale successful solutions across the broader CMC/pipeline organization.
Establish scalable, repeatable processes and tooling standards that improve transparency, accountability, and execution speed across CMC programs.
Lead or contribute to special projects involving process improvements, change management, and operational efficiency.