Principal Engineer, CMC Development Pilot Operations

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

The Role

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.

This is an onsite role based at Moderna’s Technology Center campus in Norwood, MA.

Here’s What You’ll Do

• 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.

Here’s What You’ll Need (Basic 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 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.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well‑being resources are designed to support you—at work, at home, and everywhere in between.

• 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

The salary range for this role is $142,500.00 - $256,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world‑class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Our Working Model

As we build our company, we have always believed an in‑person culture is critical to our success. Moderna champions the significant benefits of in‑office collaboration by embracing a 70/30 work model. This 70% in‑office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke‑free, alcohol‑free, and drug‑free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is an E‑Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [e-mail].