Principal Engineer, CMC Development Pilot Operations

Moderna • Norwood, MA

1d • $142,500 - $256,500 • Onsite

About The Position

Moderna’s CMC Development Pilot Operations team is seeking a Principal Engineer to lead integrated LNP and formulation operations supporting non-GMP IND as well as ASU enabling manufacturing. This role will be responsible for delivering high-quality material with agility and speed across early development, toxicology, and process development. This leader will be accountable for building and operating a phase-appropriate manufacturing model that enables rapid execution while maintaining quality, compliance, safety, and technical rigor. The role requires deep experience in a pre-clinical manufacturing environment, strong understanding of ALCOA principles, and the ability to lead cross-functional execution in a fast-paced, science-driven setting. The Principal Engineer will partner closely with CMC Dev Quality, analytical testing laboratories, Process Development, Engineering, Safety, Digital, and the GMP manufacturing facility to ensure seamless material delivery, technical readiness, operational excellence, and robust transfer of product and process knowledge across the manufacturing network.

Requirements

• Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline
• Minimum of 5 years (PhD), 10 years (MS), 12 years (BS) industry experience in biopharmaceutical development
• Experience in managing development teams and serving on or leading such teams comprising membership from various functional areas.
• Experience in pilot operations and commercialization of a range of relevant LNP and formulation experience.
• Knowledge and understanding of technology transfer from PD to the pilot facility and from the pilot facility to GMP manufacturing .
• Prior management and mentorship experience; passion for people management and development
• Ability to work independently as well as part of a team in a highly dynamic, fast-paced, matrixed environment with rapidly evolving priorities.

Responsibilities

• Lead LNP and formulation manufacturing operations supporting IND and ASU enabling manufacturing activities.
• Provide leadership for the LNP/formulation group, ensuring scientific and technical understanding is seamless between process development through manufacturing execution.
• Build and operate an agile development manufacturing model in the LNP/formulation space capable of rapidly delivering material for toxicology studies, process development studies, and technology evaluation.
• Ensure manufacturing operations are executed in a phase-appropriate manner, balancing speed, compliance, scientific rigor, and operational discipline.
• Partner with CMC development Quality to ensure appropriate deviation management, batch disposition readiness, and phase-appropriate compliance.
• Partner with analytical testing laboratories to ensure testing readiness, sample flow, analytical timelines, investigation support, and timely release of material.
• Ensure operational readiness across people, process, materials, equipment, facilities, documentation, and testing prior to manufacturing execution.
• Drive technical problem-solving during manufacturing campaigns, including real-time escalation, deviation response, root-cause analysis, and implementation of corrective and preventive actions.
• Ensure learnings from manufacturing activities are captured, communicated, and incorporated into future strategies.
• Foster a culture of scientific curiosity, ownership, accountability, collaboration, compliance, and urgency.

Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Principal