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Engineer III, Process Development

External
Moderna logoModerna · Norwood, MA
Full-timeOn-site4d ago
ComplianceDocumentationSystem Design
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About the role

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 At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. 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 The salary range for this role is $89,900.00 - $143,800.00. 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 n

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Engineer III, Process Development at Moderna