Engineer III, Process Development
About The Position
Moderna is 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.
Requirements
- 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.
Nice To Haves
- 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
- 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.
Responsibilities
- 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).
Benefits
- Best-in-class healthcare coverage, 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 investment opportunities to help you plan for the future
- Location-specific perks and extras
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
