Engineer III, Process Development

Technical Development Scientist

Moderna is working to develop first-in-class messenger RNA (mRNA) based medicines. We are seeking a highly skilled and motivated individual to join Moderna's Technical Development organization in Norwood, MA.

In this role, you will support the development of manufacturing processes for Moderna's mRNA-based medicines to enable clinical and commercial supply, with a focus on process understanding and process control strategy definition, and the transfer of established RNA production processes into fully integrated, automated, next-generation manufacturing systems. The ideal candidate will combine deep expertise in RNA manufacturing with a systems-level mindset, enabling the design and implementation of next-generation equipment and end-to-end production workflows.

The individual will act as a subject matter expert (SME), collaborating with cross-functional teams in R&D, MS&T, and Manufacturing to apply standardized design practices and deliver innovative solutions aligned with Moderna's engineering and quality standards.

Here's What You'll Do

• Serve as a technical SME for RNA manufacturing processes (e.g. IVT, purification) and translate processes into detailed functional and technical requirements for automated systems.

• Participate in the development of process flow diagrams (PFDs), P&IDs, User Requirement Specifications (URS), and Functional Requirement Specifications (FRS) for Drug Substance of manufacturing systems.

• Support the design, scale-up, and implementation of modular and small-scale process skids in alignment with GxP requirements and Moderna's global standards.

• Partner with engineering, automation, and equipment vendors to design novel manufacturing platforms that enable closed and continuous operations that meet performance, safety, regulatory, and data integrity requirements.

• Contribute to Clean-In-Place (CIP) system design and optimization, focusing on process safety, efficiency, and reliability.

• Contribute to technical reviews, design evaluations, and standardization initiatives under Moderna's Technical Authority governance model.

• Ensure compliance with GxP/GMP regulations and Moderna's quality and documentation systems.

• Support global site startup activities via tech transfer, process investigations and provide person-in-plant support may require domestic or international travel (up to 15% of working time).

Here's What You'll Need (Basic Qualifications)

• BS or MS in chemical engineering, biological engineering, chemistry, biochemistry, or closely related field
• BS with 5+ years, or MS with 2+ years of relevant industry experience in bioprocess development, pharmaceutical development, or closely related area
• Hands-on experience with chromatography, ultrafiltration, normal flow filtration, and/or development of innovative unit operations or experience in nucleic acid drug development (DNA, RNA, oligonucleotides) and/or nanoparticle delivery.
• Experience in designing, executing, and analyzing scientific experiments
• Proven ability to support process design and equipment specification in a regulated manufacturing setting.

Here's What You'll Bring to the Table (Preferred Qualifications)

• Experience in technology transfer and optimization of manufacturing processes.
• Familiarity with bioprocess skid design, automation, and process analytical technologies (PAT).
• Experience supporting or leading cross-functional technical projects.
• Exposure to personalized medicine or individualized manufacturing processes
• Certifications/Training:
  GxP/GMP compliance training.
• Strong understanding of FDA, EMA, and ICH regulations.
• Strong communication and collaboration skills across functional teams and organizational levels.
• Demonstrated ability to manage multiple technical priorities within a fast-paced, matrixed environment.
• Proven problem-solving and analytical skills to identify and resolve complex technical issues.
• Commitment to data integrity, safety, and quality excellence in all work activities.

Pay & Benefits

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