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5 дней назад

Manager CMC Program Operations (AI)

141 698 - 173 186$
Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Manager CMC Program Operations (AI) (biopharma and cell & gene therapy): Building integrated CMC project plans, dashboards, and AI-enabled reporting tools to improve program visibility and execution with an accent on critical-path management, regulatory commitments, and operational automation. Focus on designing risk-flagging models, coordinating cross-functional CMC workstreams, and scaling digital processes across the pipeline organization.

Location: Cambridge, Massachusetts, United States

Base salary: $141,698–$173,186 per year, plus performance-based annual bonus and equity compensation.

Company

Develops curative genome-editing treatments for severe and life-threatening diseases.

What you will do

  • Build and maintain integrated CMC project plans, including task interdependencies, critical paths, monitoring mechanisms, and schedule-risk tracking.
  • Design and deploy AI-assisted and automated tools such as dashboards, natural-language status summaries, and predictive risk-flagging models.
  • Publish recurring dashboards and executive-ready reports covering progress, critical-path changes, program health, and emerging risks.
  • Manage CMC meetings, agendas, minutes, action items, risk registers, mitigation plans, and escalation processes.
  • Coordinate Regulatory, Process Development, Manufacturing, Supply Chain, and Quality stakeholders to track RtQ and post-approval commitments.
  • Modernize CMC workflows and scale successful digital tools, process improvements, and operational standards across the pipeline organization.

Requirements

  • Strong project management fundamentals using MS Project, Smartsheet, or similar tools, with critical-path and risk-management experience.
  • Experience using generative AI, automation, low-code/no-code platforms, scripting, Power BI, Tableau, or similar tools for operational reporting and risk analysis.
  • Working knowledge of GMP, quality, supply chain, and regulatory requirements in biopharma or cell and gene therapy.
  • At least 6 years of experience in biopharmaceutical or life sciences organizations, including CMC development, with at least 2 years in CMC or operations project management.
  • Bachelor’s degree in a relevant field; PMP certification is preferred.
  • Ability to influence without authority across matrixed teams, communicate effectively, manage stakeholders, and operate in an ambiguous environment.

Nice to have

  • Cell and gene therapy experience.
  • Hands-on experience building or deploying AI-enabled or automated operations-reporting tools.
  • PMP certification.

Culture & Benefits

  • Mission-driven work focused on curative genome-editing treatments.
  • Values centered on collaboration, curiosity, innovation, execution, and high standards.
  • Performance-based annual cash bonus.
  • New-hire equity grant and eligibility for annual equity awards.
  • Applications are accepted on a rolling basis until the position is filled.

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