Manager CMC Program Operations

Posted 4 Days Ago
Be an Early Applicant
Cambridge, MA, USA
In-Office
142K-173K Annually
Senior level
Biotech
The Role
Leads CMC program operations, project planning, risk management, regulatory commitment tracking, dashboards, and executive reporting. Partners cross-functionally across Regulatory, Manufacturing, Quality, Supply Chain, and Process Development teams. Designs and deploys AI-enabled automation, reporting, and risk-flagging tools to improve operational visibility and decision-making. Establishes scalable CMC processes, facilitates meetings, drives follow-through, and supports process improvement and digital transformation across biopharmaceutical programs.
Summary Generated by Built In

Why Join Intellia? 

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.

Duties/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.

Requirements

Skills/Abilities

  • 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.

Education / Certifications

Bachelor’s degree in a relevant field, PMP certification preferred

Experience

  • 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

Physical Requirements

N/A

#LI-KO1

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Applications are accepted on a rolling basis, and will continue to be accepted until the position is filled at which point the position will be taken down.

The base salary for this position is expected to range between $141,698.00 - $173,186.00 USD per year.

The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs. Upon joining Intellia, your salary will be reviewed periodically and additional factors such as time in role and performance will be considered. Intellia may change the published salary range based on company and market factors.

Additional compensation includes a performance-based annual cash bonus, a new hire equity grant, and eligibility to be considered for annual equity awards the value of which are determined annually at the Company’s discretion.

For more information about Intellia’s benefits, please click here.

Skills Required

  • Bachelor's degree in a relevant field
  • 6+ years of experience in biopharmaceutical or life sciences, including CMC development
  • 2+ years of dedicated CMC or operations project management experience
  • Strong project management fundamentals using MS Project, Smartsheet, or similar tools
  • Critical-path and risk-management experience
  • Working knowledge of GMP, quality, supply chain, and regulatory requirements in a biopharmaceutical or cell and gene therapy context
  • Ability to influence without authority across matrixed, cross-functional teams
  • Excellent written and verbal communication skills
  • Stakeholder management skills
  • Strong organizational skills and attention to detail
  • Experience operating in a fast-paced, ambiguous environment
  • Experience using AI or automation tools to build operational solutions
  • Hands-on experience building or deploying AI-enabled or automated tools for program or operations reporting
  • PMP certification
  • Cell and gene therapy experience
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The Company
HQ: Cambridge, MA
668 Employees
Year Founded: 2014

What We Do

Intellia Therapeutics is a leading genome editing company whose mission is to develop potentially curative gene editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. We are focused on the development of proprietary therapeutics using a recently developed biological tool known as the CRISPR/Cas9 system. The promise of the CRISPR/Cas9 system is the driving force behind the creation of Intellia. Our founders have a shared belief that the CRISPR/Cas9 technology has the potential to transform medicine by permanently editing disease-associated genes in the human body with a single treatment course. This technology offers the potential for us to develop curative therapeutic options for patients with chronic diseases by addressing the underlying cause of the disease. It can bring new hope and cures to people who now have nowhere to turn for help. Our combination of deep scientific expertise and clinical development experience, along with our leading intellectual property portfolio, puts Intellia in a unique position to unlock broad therapeutic applications of the CRISPR/Cas9 technology and create a new class of therapeutic products. Intellia has the right people, assets and ambitious vision needed to take full advantage of the CRISPR/Cas9 technology’s attributes – high potency, specificity, simplicity of use, broad applicability, and multifunctional programmability – and accelerate the advancement of curative products into the clinic. View our social media community guidelines at https://www.intelliatx.com/terms-and-conditions/

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