Senior LNP & Formulation Manufacturing Engineer

BioSpace; Norwood (MA); On-site; USD 143,000 - 257,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being resources

Paid time off & sabbatical

Job summary

Moderna's CMC Development Pilot Operations seeks a Principal Engineer to lead integrated LNP and formulation operations supporting non-GMP IND and ASU enabling manufacturing. You will build and operate a phase-appropriate manufacturing model ensuring quality, compliance, safety, and speed in early development to process development stages.

The role requires deep pre-clinical manufacturing experience, ALCOA principles, and the ability to lead cross-functional execution in a fast-paced,

Qualifications

• Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline.
• 5 years (PhD), 10 years (MS), 12 years (BS) industry experience in biopharmaceutical development.
• Experience in managing development teams and leading cross-functional teams.
• Experience in pilot operations and commercialization of LNP/formulation experiences.
• Knowledge and understanding of technology transfer from PD to pilot facility and from pilot facility to GMP manufacturing.
• Prior management and mentorship experience; passion for people development.
• Ability to work independently as well as in a fast-paced, matrixed environment.

Responsibilities

• Lead LNP and formulation manufacturing operations for IND and ASU enabling manufacturing.
• Provide leadership for the LNP/formulation group across PD to manufacturing.
• Build and operate an agile development manufacturing model for toxicology studies and process development.
• Ensure manufacturing is executed with 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 material release timelines.
• Ensure readiness of people, process, materials, equipment, facilities, documentation, and testing before manufacturing.
• Drive problem-solving during manufacturing campaigns and implement CAPAs.
• Capture learnings and apply to future manufacturing strategies.
• Foster a culture of curiosity, ownership, collaboration, and urgency.

Skills

Leadership

Team management

Pilot operations

Technology transfer

Biopharma development

Independent work

Education

Chemical/Biomedical Engineering degree

Pharmaceutical Sciences degree

Job description

Moderna's CMC Development Pilot Operations seeks a Principal Engineer to lead integrated LNP and formulation operations supporting non-GMP IND and ASU enabling manufacturing. You will build and operate a phase-appropriate manufacturing model ensuring quality, compliance, safety, and speed in early development to process development stages.

The role requires deep pre-clinical manufacturing experience, ALCOA principles, and the ability to lead cross-functional execution in a fast-paced,