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13 дней назад

Principal Engineer, CMC Development Pilot Operations (LNP and Formulation)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
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
Principal Engineer, CMC Development Pilot Operations (LNP and Formulation): Leading integrated LNP and formulation operations for non-GMP IND, ASU-enabling manufacturing, toxicology, and process development with an accent on phase-appropriate manufacturing, quality, compliance, safety, and technical rigor. Focus on building and operating rapid pre-clinical manufacturing workflows, coordinating cross-functional technical execution, and transferring product and process knowledge across the manufacturing network.

Location: Onsite at hirify.global’s Technology Center campus in Norwood, Massachusetts, United States. hirify.global follows a 70/30 work model with 70% in-office collaboration.

Company

hirify.global develops mRNA-based medicines and vaccines using its mRNA science, delivery technology, and manufacturing platform.

What you will do

  • Lead integrated LNP and formulation operations supporting non-GMP IND and ASU-enabling manufacturing.
  • Deliver high-quality materials across early development, toxicology, and process development.
  • Build and operate a phase-appropriate manufacturing model for rapid execution.
  • Maintain quality, compliance, safety, and technical rigor across pilot operations.
  • Coordinate with CMC Development Quality, analytical laboratories, Process Development, Engineering, Safety, Digital, and GMP manufacturing teams.
  • Support technical readiness, operational excellence, and transfer of product and process knowledge across the manufacturing network.

Requirements

  • Deep experience in a pre-clinical manufacturing environment.
  • Strong understanding of ALCOA principles.
  • Ability to lead cross-functional execution in a fast-paced, science-driven environment.
  • Experience with LNP and formulation operations, manufacturing, or process development.
  • Ability to work onsite at the Norwood, Massachusetts campus.

Culture & Benefits

  • In-person culture emphasizing innovation, teamwork, and direct mentorship.
  • Benefits and well-being resources designed to support employees at work and at home.
  • Smoke-free, alcohol-free, and drug-free work environment.
  • Equal employment opportunity and reasonable workplace accommodations.

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