13 дней назад
Principal Engineer, CMC Development Pilot Operations (LNP and Formulation)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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 ’s Technology Center campus in Norwood, Massachusetts, United States. follows a 70/30 work model with 70% in-office collaboration.
Company
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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