远程工作雷达

CMC项目运营经理

Manager CMC Program Operations

职能支持限定地区(需当地身份)
公司Intellia Therapeutics, Inc.
薪资$141,698 - $173,186/年
工作地点United States
地域资格限定地区(需当地身份)
时区要求日间重叠约 9 小时,基本正常作息
用工类型Full Time
发布时间今天
数据来源Himalayas
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注意地域限制:该职位明确限定在 United States 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。

为什么加入Intellia?

我们的使命是开发能够积极改变严重和危及生命疾病患者生活的治愈性基因编辑疗法。

除了科学,我们践行四大核心价值观:团结、探索、颠覆、交付,并坚信在Intellia你可以实现更多。我们一心一意追求卓越与共同成功。我们相信好奇心和突破边界的强大动力。我们欢迎挑战性的想法和想象力,以开发创新解决方案。我们知道患者正期待我们兑现承诺,因此我们必须保持高标准并完成任务。

我们希望每一位员工都能超越可能的界限。我们不受传统终点限制,也不只是“治疗”患者。我们在此追求更深远的目标。我们致力于治愈并推动变革。想象一下我们能一起实现的可能。

随着Intellia不断推进其产品管线,这个新设立的职位体现了公司对运营卓越、可扩展项目管理以及CMC领域数字化转型的承诺。
CMC项目运营经理将作为CMC团队的运营和数字赋能负责人,直接与商业CMC团队负责人合作,构建和维护集成的项目计划、仪表盘和报告工具,以推动执行。该职位超越传统的项目协调,负责设计和部署实用、生成式和代理式AI驱动的工具(例如智能仪表盘、自动生成的状态报告、风险预警模型),以提高可见性,减少手动跟踪负担,并加快CMC各工作流的决策速度。该经理将推动跨职能协作,跟踪项目风险,管理监管承诺时间线,并作为商业CMC团队的主要运营联系人,同时有机会影响更广泛的平台和组合运营。

职责/责任

  • 构建和维护主CMC项目计划(MS Project、Smartsheet或同等工具),识别任务依赖关系、关键路径和进度风险监控机制。
  • 设计和实施AI辅助或自动化工具(例如仪表盘自动化、自然语言状态摘要、预测性风险预警)以减少手动报告工作量,并提高项目健康状况的实时可见性。
  • 定期发布
查看英文原文

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 wantall ofour 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
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.
Originally posted on Himalayas

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