Senior LNP & Formulation Manufacturing Leader

RXinsider LTD.; Norwood (MA); Hybrid; USD 143,000 - 257,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Retirement planning

Location-specific perks

Job summary

Moderna seeks a Principal Engineer for the CMC Development Pilot Operations team in Norwood, MA, to lead LNP and formulation operations for IND and ASU enabling manufacturing. You will build a phase-appropriate manufacturing model delivering high-quality material quickly while ensuring compliance and safety.

You will partner with CMC Dev Quality, analytical labs, Process Development, and GMP facilities to ensure readiness and robust transfer of knowledge.

Qualifications

• 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 LNP/formulation.
• Knowledge of technology transfer from PD to pilot facility and from 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 dynamic, fast-paced environment.

Responsibilities

• Lead LNP and formulation manufacturing operations supporting IND and ASU enabling manufacturing activities.
• Provide leadership for the LNP/formulation group across PD to manufacturing execution.
• Build and operate an agile development manufacturing model in LNP/formulation for toxicology studies and process development.
• Ensure manufacturing operations are phased to balance speed, compliance, and scientific rigor.
• Partner with CMC development Quality for deviation management and batch disposition readiness.
• Coordinate with analytical labs for testing readiness and timely material release.
• Ensure readiness across people, process, materials, equipment, facilities, documentation, and testing.
• Drive problem-solving during campaigns, including deviation response and CAPAs.
• Capture and incorporate learnings into future strategies.

Skills

Leadership

Cross-functional collaboration

Project management

Manufacturing operations

Education

Degree in Chemical/Biomedical Engineering or related discipline

Job description

Moderna seeks a Principal Engineer for the CMC Development Pilot Operations team in Norwood, MA, to lead LNP and formulation operations for IND and ASU enabling manufacturing. You will build a phase-appropriate manufacturing model delivering high-quality material quickly while ensuring compliance and safety.

You will partner with CMC Dev Quality, analytical labs, Process Development, and GMP facilities to ensure readiness and robust transfer of knowledge.