Назад
Company hidden
6 дней назад

Sr. CMC Project Manager

135 000 - 150 000$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
/
TL;DR
Sr. CMC Project Manager (Small-Molecule Drug Development): Leading portfolio-level CMC planning and execution for small-molecule assets from initial tox supplies through Phase 2 scale-up across drug substance and drug product with an accent on timelines, budgets, CDMO coordination, and regulatory documentation. Focus on building risk registers and controlled document workflows, managing manufacturing campaigns and deliverables across multiple geographies, and applying AI and automation safely to operational workflows.

Location: Remote, United States

Salary: $135,000–$150,000 annually

Company

hirify.global is a clinical-stage, AI-enabled biotech developing medicines and has raised $311M in Series E funding.

What you will do

  • Lead program- and portfolio-level CMC planning and execution for multiple small-molecule assets from initial tox supplies through Phase 2 scale-up across drug substance and drug product.
  • Own CMC project plans, risk registers, development strategies, timelines, deliverables, and budget tracking.
  • Coordinate CROs and CDMOs across China, the EU, and the US, including manufacturing campaigns, batch execution timelines, documentation, issue escalation, and closure.
  • Chair cross-functional and CDMO meetings, track actions and decisions, and communicate project status, risks, and mitigation strategies.
  • Manage proposals, purchase orders, change orders, multi-year budget forecasts, commitments, accruals, and variance analysis.
  • Improve controlled document review workflows and identify opportunities to accelerate timelines, streamline execution, and anticipate resourcing needs.

Requirements

  • B.S., M.S., or Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a similar field; M.S. or Ph.D. preferred.
  • 5+ years of CMC project management experience in biotech or pharma, including hands-on small-molecule drug substance and drug product development from IND-enabling through early clinical phases.
  • Familiarity with analytical method development, process chemistry, formulation, and regulatory documentation.
  • Experience managing external CROs and CDMOs across multiple geographies, including planning, communication, deliverable quality, and issue escalation and closure.
  • Ability to lead cross-functional initiatives, set priorities, and manage timelines and budgets in a resource-constrained, fast-paced environment.
  • Experience designing and operating structured document workflows, approval processes, and standards in a GxP and submission-relevant context.
  • Experience or strong interest in applying AI and automation to operational workflows with safety, transparency, and human oversight.
  • Strong technical and operational aptitude with Smartsheet, Box, Domo, Slack, and Zoom, plus comfort building or owning custom applications and integrations.
  • Excellent oral and written communication, organizational, interpersonal, problem-solving, flexibility, adaptability, and resourcefulness skills.

Nice to have

  • PMP certification.
  • Late-stage development experience.

Culture & Benefits

  • Remote, full-time role in a fast-paced startup environment.
  • Medical, dental, and vision coverage at 90% starting Day 1.
  • 401(k) with company match, flexible PTO, and a company-wide weeklong recharge break.
  • Adoption assistance.
  • Values include Curiosity, Agency, Journey, Charity, and Unity.

Hiring process

  • Recruiter screen followed by a hiring manager conversation.
  • Work sample, technical interview, and culture interview.
  • Applicants will communicate with real hirify.global team members through video or in-person conversations; official communication comes from an @hirify.global.com or @hirify.globalbio.com address.

Будьте осторожны

Если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого. Это мошенники. Обязательно жмите «Пожаловаться» или пишите в поддержку. Подробнее в гайде →